Phase 2 Study of Paclitaxel (NSC #673089) + Ipatasertib (NSC #781451) in Taxane-Refractory Participants With PTEN/AKT-Altered Advanced Non-Breast Solid Tumors: A ComboMATCH Treatment Trial

This phase II ComboMATCH treatment trial tests the usual treatment of chemotherapy (paclitaxel) plus ipatasertib in patients with solid tumor cancers that that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced) or from where it first started (primary site) to other places in the body (metastatic), and has PTEN and AKT genetic changes. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy, such as Ipatasertib, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of ipatasertib to paclitaxel in solid tumors with PTEN and AKT genetic changes could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression). Researchers hope to learn if paclitaxel plus ipatasertib will shrink this type of cancer or stop its growth.

Start Date22 Sep 2023

Sponsor / Collaborator

National Cancer Institute

NCT05332561

/ RecruitingPhase 2IIT

Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer - a Multicenter, Open-label, Umbrella Phase-II Study - COGNITION-GUIDE

In early breast cancer (eBC), pathological complete response (pCR) after neoadjuvant therapy acts as surrogate marker for metastasis and overall survival. Therapy intensification by adding an adjuvant therapy line (post-neoadjuvant treatment) substantially lowers the risk of relapse in high-risk breast cancer patients with residual disease after neoadjuvant treatment (non-pCR). While this approach was exemplified in two phase III trials without biomarker-stratification (CREATE-X, KATHERINE), even higher efficiency might be achieved by individualized genomic-guided post-neoadjuvant therapies.
Within the seven-arm umbrella phase-II clinical trial COGNITION-GUIDE, we aim to deliver molecularly-tailored cancer care by implementing an additional response- and genomics-guided post-neoadjuvant therapy after finishing the guideline-compliant post-neoadjuvant treatment in high-risk breast cancer patients with residual cancer burden after neoadjuvant therapy to reduce the substantial risk of local and distant relapse.
The trial evaluates not a single drug but rather a general strategy of precision oncology in the curative setting and provides the basis for future confirmatory biomarker-driven trials.
Allocation to the therapy-arms is conducted by in depth molecular characterization of tumors within the COGNITION registry program.
The study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of each study-arm.
The primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years measured from surgery to local or distant relapse or death. The sample size of the entire trial is 240 eligible patients.

Start Date29 Jun 2023

Sponsor / Collaborator

German Cancer Research Center

NCT05862285

/ RecruitingPhase 3

An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study

The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.

Start Date01 Jun 2023

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

100 Clinical Results associated with Ipatasertib Dihydrochloride

100 Translational Medicine associated with Ipatasertib Dihydrochloride

100 Patents (Medical) associated with Ipatasertib Dihydrochloride

228

Literatures (Medical) associated with Ipatasertib Dihydrochloride

04 Feb 2026·CLINICAL CANCER RESEARCH

Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Article

Author: Ciruelos, Eva ; Pascual, Tomás ; Saura, Cristina ; Chillara, Samyukta ; Tolosa, Pablo ; Bergamino, Milana ; Oliveira, Mafalda ; Paes Dias, Mariana ; Salvador, Fernando ; Morales, Serafín ; Vega, Estela ; Salvador Bofill, Javier ; Quiroga, Vanesa ; Ferrero-Cafiero, Juan M. ; Servitja, Sonia ; Villacampa, Guillermo ; Gonzalez Farre, Xavier ; Henao, Fernando ; Gavilá, Joaquín ; Cortegoso, Alexandra

Abstract:

Purpose::

The aim of this study was to evaluate the safety and feasibility of ipatasertib combined with trastuzumab and pertuzumab (HP) as maintenance therapy after first-line treatment in patients with HER2-positive metastatic breast cancer harboring PIK3CA mutations (PIK3CAmut).

Patients and Methods::

This prospective, multicenter, single-arm, phase Ib study evaluated the safety and preliminary efficacy of ipatasertib, an AKT inhibitor, combined with HP, with or without endocrine therapy as maintainance therapy, in patients with unresectable locally advanced or metastatic PIK3CAmut, HER2-positive breast cancer following first-line induction chemotherapy and HP.

Results::

Seventeen patients were enrolled, with a median follow-up of 27.7 months. During the dose-selection phase, ipatasertib at 400 mg daily (21 days on and 7 days off) with standard HP was established as the recommended phase II dosage. This decision was based on the absence of dose-limiting toxicities in the first six patients treated at this dosage during the initial 28-day cycle, which constituted the primary endpoint. Grade 3 treatment-related adverse events (TRAE) occurred in seven patients (41.2%), most commonly diarrhea and nausea. Two (11.8%) reported four serious TRAE (diarrhea, vomiting, ischemic stroke, and pneumonitis, one case each) related to ipatasertib, from which they recovered. The confirmed overall response rate was 31.1% [95% confidence interval (CI), 12.1%–58.5%], clinical benefit rate 84.6% (95% CI, 53.7%–97.3%), and median progression-free survival 16.4 months (95% CI, 9.4–NR); 47.3% of patients were progression free at 18 months.

Conclusions::

These results support ipatasertib plus HP as a safe and promising maintenance strategy for HER2-positive breast tumors harboring PIK3CAmut.

01 Feb 2026·Translational Stroke Research

Transplantation of Skin-Derived Precursor Schwann Cells Ameliorates Secondary Brain Injury after ICH in Mice by Activating the PI3K/AKT/FOXO3a Signaling Pathway

Article

Author: Li, Aihong ; Sun, Qiuwen ; Sha, Junyi ; Song, Yan ; Tang, Yuqian ; Shen, Jiabing ; Xue, Chengbin ; Zhang, Yejing ; Chen, Yan ; Tong, Muyuan

This study investigated the therapeutic potential of skin-derived precursor Schwann cells (SKP-SCs) for secondary brain injury following intracerebral hemorrhage (ICH) and its underlying mechanisms. An ICH model was established in mice via intrastriatal autologous blood injection. SKP-SCs were administered intranasally 24 h post-ICH, with the AKT inhibitor GDC0068 used for intervention. Results demonstrated that transplanted SKP-SCs survived peri-hematomally, significantly improved short- and long-term neurological function, reduced brain tissue damage and neuronal apoptosis, preserved blood-brain barrier integrity, and suppressed microglial/macrophage activation and neutrophil infiltration. Mechanistically, SKP-SCs exerted neuroprotection by activating the PI3K/AKT/FOXO3a signaling pathway. In conclusion, intranasal SKP-SC transplantation alleviates ICH-induced deficits and secondary injury via this pathway, representing a promising therapeutic strategy during the acute phase following ICH.

01 Dec 2025·CLINICAL CANCER RESEARCH

Ipatasertib in Patients with Tumors with AKT Mutations: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1K

Article

Author: Chen, Alice P. ; Harris, Lyndsay N. ; Rubinstein, Larry V. ; Patton, David R. ; McCourt, Carolyn K. ; McShane, Lisa M. ; Hamilton, Stanley R. ; O’Dwyer, Peter J. ; Kalinsky, Kevin ; Gray, Robert ; Force, Jeremy ; Williams, P. Mickey ; Wei, Zihan ; Pakanati, Anuradha ; Conley, Barbara A. ; Tricoli, James V. ; Wang, Victoria ; Arteaga, Carlos ; Flaherty, Keith T.

Abstract:

Purpose::

Activating mutations in AKT genes are rare but play an important role in the commonly dysregulated PI3K/AKT/mTOR signaling pathway in multiple cancers. NCI-MATCH (EAY131) is a tumor-agnostic platform trial that enrolled patients to targeted therapies based on matching tumor genomic alterations. Subprotocol Z1K evaluated ipatasertib, a pan-AKT inhibitor, in patients with AKT1E17K-mutant metastatic tumors.

Patients and Methods::

Patients received ipatasertib 400 mg orally once daily in a 28-day cycle until progression or unacceptable toxicity. Patients with well-controlled diabetes were eligible. Patients with known KRAS, NRAS, HRAS, or BRAF mutations were excluded. Prior PI3K and mTOR inhibitors were allowed. Prior AKT inhibitors were excluded. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival, 6-month progression-free survival, and toxicity.

Results::

Thirty-five patients were enrolled, and 29 patients were included in the prespecified primary efficacy analysis. Multiple histologies were enrolled, with breast (n = 18) and gynecologic (n = 7) being the most common. The majority had >3 lines of prior therapy (19/29; 65.5%). The ORR was 24.1% (7/29; 90% confidence interval, 11.9%–40.6%) with P < 0.001 against a null rate of 5%. All responses were partial responses. The median response duration was 10.1 months (90% confidence interval, 3.7–10.8). The most common toxicities of any grade included diarrhea (n = 25), nausea (n = 13), and hyperglycemia (n = 9). Grade 3/4 toxicities observed were consistent with reported toxicities for AKT inhibition. Twelve grade 3 events occurred that were thought to be at least possibly related to treatment.

Conclusions::

The study met its primary endpoint with an ORR of 24.1% (P < 0.001), with ipatasertib demonstrating clinically significant activity in heavily pretreated patients with various tumors harboring AKT1E17K mutations.See related commentary by Dahmer Tiecher and Schram, p. 4863

News (Medical) associated with Ipatasertib Dihydrochloride

13 Sep 2024

·www.fiercepharma.com

ESMO: AstraZeneca stands by Truqap despite surprise breast cancer flop

The lack of showing for Truqap in gene-altered patients was disappointing as the AstraZeneca AKT inhibitor was expected to work better in this subgroup. As if a limited initial FDA approval was not bad enough, AstraZeneca’s Truqap has recorded a pivotal trial flop that could raise additional doubts around the first-in-class AKT inhibitor. From AZ’s perspective, a company executive argued the failure was probably a one-off.Through and through, the phase 3 CAPItello-290 study was a bust. Truqap, when added to the chemotherapy paclitaxel, failed to extend the lives of patients with newly diagnosed metastatic triple-negative breast cancer or those in a subgroup with alterations in one of the PIK3CA, AK1 and PTEN genes.It was not a close call at all. The death risks between chemo and the Truqap-chemo combo were roughly the same in both analyses, according to data presented at the European Society for Medical Oncology Congress 2024. Patients in the Truqap arm lived a median 17.7 months, versus 18 months for control. In patients with the gene-altered tumors, the median overall survival was the same at 20.4 months between the two arms.While the study was designed to measure the drug’s survival benefits as the primary endpoint, Truqap did show a numerical advantage in reducing the risk of disease progression or death. The AZ drug reduced this risk by 28% compared with paclitaxel in the overall trial population and 30% in the gene-altered subgroup. Apparently, that didn’t translate into any life-extension benefit.The lack of showing in gene-altered patients was particularly disappointing as Truqap was expected to work better in this subgroup. The drug’s initial FDA nod in HR-positive, HER2-negative breast cancer, obtained in November, is limited to gene-altered patients because the FDA saw the most convincing effects there. The addition of Truqap to chemotherapy led to new toxicities in CAPItello-290. Notably, among adverse events that are grade 3 or above, the rates of diarrhea were 12.7% and 0.7% for Truqap and control, respectively. The rate of neutropenia was also slightly higher for AZ's medicine. Adverse events led to an 8.5% rate of treatment discontinuations in the experimental arm, compared with 4.9% in control.Cristian Massacesi, AstraZeneca’s chief medical officer and oncology chief development officer, argued that safety wasn’t the reason behind Truqap’s defeat in TNBC. Instead, he said that the data speak to “the fact that the practice is changing.” Although Massacesi didn’t elaborate, new therapies such as Gilead Sciences’ Trodelvy have emerged as later-line treatments for TNBC since CAPItello-290 commenced in 2019. Strong subsequent therapies may sometimes muddy the effect of a first-line drug, especially around overall survival.The control arm in CAPItello-290 performed markedly better than the control group in the phase 2 PAKT trial, which prompted AZ to move Truqap into phase 3 testing in first-line TNBC. Patients who received chemo alone lived a median 12.6 months in that phase 2 trial but 18 months in the new phase 3 study. In control patients with gene-altered tumors, the median progression-free survival time was 3.7 months in phase 2, versus 5.6 months in phase 3.TNBC was not meant to be Truqap’s core indication, and the CAPItello-290 failure does not affect AZ’s understanding of the drug in other ongoing phase 3 trials, including in HR+/HER2- breast cancer and prostate cancer, Massacesi told Fierce.The CAPItello-292 study was intended to move Truqap one line earlier in the treatment sequence than its existing U.S. indication. Unlike TNBC, the relevance of the PI3K/AKT pathway is very well-established in HR+/HER2- breast cancer, Massacesi noted. There, Novartis’ PI3K inhibitor Piqray has been approved in patients with PIK3CA-mutated tumors.As for prostate cancer, the CAPItello-281 trial, which could read out this year, is only being conducted in metastatic hormone-sensitive prostate cancer that’s PTEN-deficient. In addition, the phase 3 CAPItello-280 trial is testing the addition of Truqap to docetaxel in metastatic castration-resistant prostate cancer (mCRPC). That study was started because AKT activation seems to be a rescue mechanism prostate cancer develops to evade docetaxel, Massacesi explained. The idea is to block that alternative pathway and maximize the effect of docetaxel. Nevertheless, AKT inhibitors’ track record in prostate cancer has not been great. Roche previously dropped development of its AKT inhibitor ipatasertib. The drug showed a tumor progression benefit in a phase 3 trial in mCPRC with PTEN loss but didn’t move the needle on overall survival. Like Truqap, ipatasertib had also failed in TNBC in the IPATunity-170 trial.Truqap might have a different fate; after all, ipatasertib had also missed the mark in HR+/HER2- breast cancer, where Truqap was successful at least in the gene-altered population.Truqap didn’t have the best start when the FDA’s initial approval in HR+/HER2- breast cancer left out patients without mutations along the PI3K/AKT pathway despite a positive phase 3 trial readout in the overall population. AZ is still following the phase 3 CAPItello-290 trial for a longer overall survival analysis, and Massacesi said the company will share more data when the time is right.

Phase 3Clinical ResultDrug ApprovalClinical Trial TerminationGene Therapy

02 Jun 2024

·www.prnewswire.com

MEDSIR's PRIMED Study Shows Promising Results for Preventing Sacituzumab Govitecan related Side Effects in the Treatment of HER2-negative Advanced Breast Cancer

The PRIMED study found a way to reduce treatment-related side effects among participants, decreasing dose reductions, treatment interruptions, and permanent discontinuations. The strategic alliance between MEDSIR and Oncoclínicas has enabled the company to present 13 studies at the 2024 ASCO Annual Meeting. CHICAGO, June 2, 2024 /PRNewswire/ -- Leading international medical research company, MEDSIR, today announced the results of the recent PRIMED clinical trial during the 2024 ASCO Annual Meeting. Carried out under the company's collaborative model, this Investigator-Initiated Trial (IIT) demonstrated the effectiveness of preventative administration of drugs to treat the common side effects of neutropenia and diarrhea that can occur while taking sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2 that has extended overall survival for patients with pretreated triple negative and HR-positive/HER2-negative advanced breast cancer in two previous Phase 3 studies, ASCENT and TROPiCS-02. In the PRIMED study, adding primary prophylactic granulocyte colony-stimulating growth factors (G-CSF) and loperamide during the first two sacituzumab govitecan treatment cycles led to clinically meaningful reductions in neutropenia and diarrhea, lowering the need for dose reductions, treatment interruptions, and permanent discontinuations. Continue Reading Dr. Antonio Llombart-Cussac and Dr. Javier Cortés at ASCO24 Dr. Antonio Llombart-Cussac and Dr. Javier Cortés at ASCO "This is an exciting finding that highlights the high potential of prophylactic strategies that can mitigate side effects to help keep patients on promising treatments, which was made possible by our collaborative research model," shared Dr. Antonio Llombart-Cussac, Senior Scientific Leader of MEDSIR. "By using a partnership model that combines the benefits of company-sponsored research with all the advantages of IITs, we are turning brilliant ideas into full clinical trials that will safely and efficiently advance cancer solutions. It is our hope that, by working together, we will continue to generate new opportunities for patients worldwide." Among PRIMED study participants, the incidence of any grade of neutropenia (in the first two cycles) was 28%, compared to 63% and 70% in ASCENT and TROPiCS-02 (in the full study), respectively. The incidence of any grade diarrhea (in the first two cycles) was 34%, compared to 59% and 57% in ASCENT and TROPiCS-02 (in the full study), respectively. The other side effects PRIMED study participants experienced were consistent to the known safety profile of sacituzumab govitecan, with the exception of constipation, which occurred in 46% of patients during the first two cycles compared to 17% in ASCENT and 19% in TROPiC-02 (in the full study). However, most cases of constipation were mild, and no patients experienced adverse events that led to permanent treatment discontinuation. The study, which is still ongoing to evaluate efficacy and collect longer-term safety data, enrolled 50 patients between February 2023 and September 2023 across 10 sites across Spain, providing them with G-CSF and loperamide during the first two sacituzumab govitecan treatment cycles (physician's decision to continue after two cycles). These two drugs are commonly used to treat neutropenia and diarrhea, respectively, but are usually administered only after these side effects occur. In PRIMED, researchers wanted to test whether early administration of these drugs, before patients experienced any neutropenia or diarrhea, could reduce the incidence of these side effects and determine how this affected the need for dose reductions, treatment interruptions, and permanent discontinuations. Showcasing Numerous Promising Collaborative Trials at ASCO PRIMED was not the only trial MEDSIR presented during the ASCO Annual Meeting. It shared the results of several other recent and ongoing studies as well. Recently published in The Lancet, MEDSIR's PHERGain phase II trial (NCT03161353) demonstrated how a third of patients with HER2-positive early breast cancer could be safely treated without using chemotherapy. At the 2024 ASCO Annual Meeting, MEDSIR presented a subanalysis of this study comparing PET scan and magnetic resonance imaging (MRI) results; both tests that participants undergo to observe the evolution of their cancer. The comparative study shows tumor assessments can be analyzed with both PET scan and MRI. Although PET scan is the recommended imaging technique for early treatment response, this exploratory study suggests that MRI could alternatively guide the treatment when PET scan are not available. MEDSIR's PATHFINDER study evaluated the safety, tolerability, and preliminary efficacy of ipatasertib in combination with non-taxane chemotherapy in patients with advanced triple negative breast cancer who had previously experienced tumor progression after treatment with taxane chemotherapy. Study results revealed that combining ipatasertib with capecitabine and eribulin has an acceptable safety profile in these patients, but that adding ipatasertib alongside carboplatin plus gemcitabine proved to be intolerable. Additionally, the combination of ipatasertib and eribulin demonstrated encouraging efficacy, warranting further investigation. TUXEDO-3, one of MEDSIR's ongoing clinical trials in Austria and Spain, is the first study evaluating the efficacy and safety of patritumab deruxtecan as an anti-cancer therapy for patients with pretreated metastatic breast cancer and advanced non-small cell lung cancer with brain metastases, and metastatic solid tumors with leptomeningeal disease. If positive, this study could streamline the introduction of HER3-DXd as a new treatment for these patients who currently have very limited therapeutic options. ABOUT UMMET CANCER NEEDS Unmet cancer needs refer to gaps in resources, support, and treatment options that exist for cancer patients. Addressing unmet cancer needs is crucial to improving quality of life and outcomes for cancer patients. Through the collaborative work of healthcare providers, policymakers, and patient advocacy groups unmet cancer needs can be identified to help provide patients with comprehensive and quality care. ABOUT MEDSIR Founded in 2012, MEDSIR works closely with its partners to drive innovation in oncology research. Based in Spain and the United States, the company manages all aspects of clinical trials, from study design to publication, utilizing a global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that helps research partners experience the best of both worlds from industry-based clinical research and investigator-driven trials. To promote independent cancer research worldwide, MEDSIR has a strategic alliance with Oncoclínicas, the leading oncology group in Brazil with the greatest research potential in South America. Learn how MEDSIR brings ideas to life at . SOURCE MEDSIR

Clinical ResultASCOPhase 2Phase 3

23 May 2024

·www.prnewswire.com

Rutgers Cancer Institute and RWJBarnabas Health Set to Unveil Extensive, New Cancer Research Findings at 2024 ASCO Annual Meeting

49 scheduled presentations will explore several types of cancer, as well as the next frontier of health equity NEW BRUNSWICK, N.J., May 23, 2024 /PRNewswire/ -- Clinicians and scientists from Rutgers Cancer Institute and RWJBarnabas Health will lead sessions and present their latest discoveries from their innovative cancer research program at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago (and online) from May 30-June 4. A total of 49 accepted abstracts and presentations will cover cutting-edge topics, including two oral sessions highlighting the National Surgical Quality Improvement Program (NSQIP) audit of enhanced recovery after surgery protocols for radical cystectomy, as well as social vulnerability and clinical trial enrollment's role in the next frontier of health equity. Continue Reading Rutgers Cancer Institute and RWJBarnabas Health "Our world-renowned integrated network of researchers and clinicians at Rutgers Cancer Institute and RWJBarnabas Health continues to innovate and investigate strategies that will achieve the best possible outcomes for our patients. This is reflected in the dynamic lineup of presentations featured at the 2024 ASCO Annual Meeting, underscoring our team's commitment and dedication," said Steven K. Libutti, MD, FACS, Director, Rutgers Cancer Institute and Senior Vice President, Oncology Services, RWJBarnabas Health. "As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center and the leading cancer program in the state, we are at the forefront of advancing cancer research and care to conquer a disease that impacts so many. We look forward to sharing our array of recent advancements and findings at this year's meeting." The research accepted for presentation at ASCO includes one late-breaking abstract, oral and poster sessions as well as publication-only abstracts highlighting data in numerous types of cancer, including breast, colorectal, lymphoma, and lung. Highlights of the accepted abstracts include the following: Findings from a study that assesses how social vulnerability impacts clinical trial enrollment and explores the interaction between race and social vulnerability among patients with one of the top five cancers - breast, prostate, lung, colorectal and pancreas. Findings confirm that neighborhood social vulnerability is a barrier to trial enrollment, even more so among Black patients. Utilization of enhanced recovery after surgery (ERAS) protocols for radical cystectomy has been associated with improved postoperative recovery and shorter hospital stays. This study was designed to assess the impact of increasing compliance to ERAS components on postoperative outcomes in patients who underwent radical cystectomy. Researchers reviewed 3,708 patients from the National Surgical Quality Improvement Program database who underwent radical cystectomy from 2019 – 2021. Updates from CTEP 10492, a Phase 1/1b study investigating the AKT inhibitor ipatasertib with chemoradiation to treat locally advanced head and neck squamous cell carcinoma (HNSCC). The primary objective of this study is to determine the maximum tolerated dose and recommended Phase 2 dose of ipatasertib in combination with definitive chemoradiation therapy (CRT) in locally advanced HNSCC based on dose-limiting toxicities. This phase 1/1b study will be the first to establish safety and preliminary efficacy of ipatasertib combined with standard of care definitive CRT for HNSCC. Data from a Phase 3 clinical trial evaluates the efficacy and safety of odronextamab plus CHOP vs rituximab plus CHOP in previously untreated diffuse large B-cell lymphoma (DLBCL) patients. OLYMPIA-3 is a Phase 3, randomized, open-label, multicenter study of O-CHOP vs. R-CHOP in patients with previously untreated DLBCL and intermediate- or high-risk features. The primary endpoints of the study are the incidence of dose-limiting toxicities, and incidence and severity of treatment-emergent adverse events as well as progression-free survival by independent central review. CIPHER (NCT05333874), a single institution pilot study, evaluated whether trend of circulating tumor DNA (ctDNA) testing during neoadjuvant therapy (NAT) can serve as an early indicator of treatment response and inform disease management in the adjuvant setting. The study included 35 patients with stage II-III triple negative and HER2+ breast cancer and longitudinal ctDNA testing performed during standard of care NAT. The full list of presentations at this year's 2024 American Society of Clinical Oncology Annual Meeting can be found here. About Rutgers Cancer Institute As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, Rutgers Cancer Institute, together with RWJBarnabas Health, offers the most advanced cancer treatment options, including bone marrow transplantation, proton therapy, CAR T-cell therapy and complex surgical procedures. Along with clinical trials and novel therapeutics such as precision medicine and immunotherapy – many of which are not widely available – patients have access to these cutting-edge therapies at Rutgers Cancer Institute in New Brunswick, Rutgers Cancer Institute at University Hospital in Newark, as well as through RWJBarnabas Health facilities. For journalists – contact: Krista Didzbalis Corporate Communications Specialist, Strategic Communications, RWJBarnabas Health 732.507.8307 [email protected] For patient appointments/inquiries – contact: 844-CANCERNJ (844-226-2376) SOURCE Rutgers Cancer Institute and RWJBarnabas Health

Phase 3ASCOImmunotherapyClinical ResultCell Therapy

100 Deals associated with Ipatasertib Dihydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Ipatasertib Dihydrochloride	-	DB11743

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	Phase 3	Australia	Hoffmann-La Roche, Inc.	27 Jan 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	Canada	Hoffmann-La Roche, Inc.	27 Jan 2021
ER-positive/HER2-negative Breast Cancer	Phase 3	New Zealand	Hoffmann-La Roche, Inc.	27 Jan 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	Czechia	-	04 Oct 2019
Triple Negative Breast Cancer	Phase 3	United States	F. Hoffmann-La Roche Ltd.	06 Jan 2018
Triple Negative Breast Cancer	Phase 3	United States	Roche China Holding Ltd.	06 Jan 2018
Triple Negative Breast Cancer	Phase 3	Japan	F. Hoffmann-La Roche Ltd.	06 Jan 2018
Triple Negative Breast Cancer	Phase 3	Japan	Roche China Holding Ltd.	06 Jan 2018
Triple Negative Breast Cancer	Phase 3	Argentina	Roche China Holding Ltd.	06 Jan 2018
Triple Negative Breast Cancer	Phase 3	Argentina	F. Hoffmann-La Roche Ltd.	06 Jan 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04650581 (FINER \| CCTG/BCT MA.40/FINER, CTgov)	Phase 3	ER-positive/HER2-negative Breast Cancer	250	fulvestrant+Ipatasertib	ozhmouhfho = ownpdyzcvv fptbdbvgyd (gnykqtauwv, xnjdvsaqcj - ozclzehejz) View more	-	28 Jan 2026
NCT06400251 (CTgov)	Phase 2	Refractory Malignant Solid Neoplasm \| Advanced Malignant Solid Neoplasm \| Advanced Lymphoma ... View more	35	Computed Tomography+Ipatasertib	zqqxoougee = rmktgdsnsw vfdqnllexx (tebwmisoww, piakllqcxr - zpghnasvwn) View more	-	26 Aug 2025
NCT04650581 (CCTG/BCT MA.40/FINER, ASCO2025) Manual	Phase 3	Breast Cancer Second line ER Positive \| HER2 Negative	250	ipatasertib plus fulvestrant	bsdbetqwoq(ksvvlehcmf) = azgpuqkivj xnfjugmaru (ghigrvvtou, 3.58 - 5.62) View more	Positive	30 May 2025
				placebo plus fulvestrant	bsdbetqwoq(ksvvlehcmf) = spspdvfsgi xnfjugmaru (ghigrvvtou, 1.84 - 3.22) View more
NCT04060862 (IPATunity150, CTgov)	Phase 1	Hormone receptor positive HER2 negative breast cancer	20	Fulvestrant+Palbociclib+Ipatasertib (Phase 1b: Ipatasertib + Palbociclib +Fulvestrant)	fnlimsftnf = fgjboigzjr pyfwpgtcpx (zfdssbyzpi, csmjqnsjrh - dasmkeflxf) View more	-	08 Nov 2024
				Fulvestrant+Palbociclib+Ipatasertib (Phase Ib: Ipatasertib + Palbociclib +Fulvestrant)	zffiylwfqe(fferftzkeg) = qhurvhpwcg axlainnddk (ernftipjtc, 52.6) View more
NCT04931342 (ENGOT-GYN2，GOG-3051，BOUQUET)	Phase 2	Ovarian Epithelial Carcinoma \| Recurrent Platinum-Resistant Ovarian Carcinoma Last line \| Second line \| Third line HER2阳性，PI3K/AKT/mTOR通路改变	41	恩美曲妥珠单抗	znqabixask(cypnoajwby) = jpocyypdip docfjirfpn (vimklydkme ) View more	Positive	05 Nov 2024
				Ipatasertib+紫杉醇Ipatasertib+紫杉醇	znqabixask(cypnoajwby) = nvqctttrmh docfjirfpn (vimklydkme )
NCT04589845 (TAPISTRY, ASCO2024) Manual	Phase 2	AKT1 mutation positive Solid Tumors \| AKT2 mutation positive Solid Tumors \| AKT3 mutation positive Solid Tumors AKT2 Mutation \| AKT3 Mutation \| AKT1 Mutation	50	Ipatasertib 400 mg	ptriwoqwtk(pwmekzfvew) = gypnfqgbkd cfjnqsklht (vdkesvcbym, 18.7 - 46.3) View more	Positive	24 May 2024
NCT04464174 (PATHFINDER, ASCO2024)	Phase 2	Advanced Triple-Negative Breast Carcinoma PI3K/AKT/mTOR pathway	54	Ipatasertib (IPA) + Capecitabine (CA)	umnedbrjho(blrormnwig) = wgwzgatiyg aehlbfdifn (xxdsqtkyfh ) View more	Positive	24 May 2024
				Ipatasertib (IPA) + Eribulin (E)	umnedbrjho(blrormnwig) = msaterrxde aehlbfdifn (xxdsqtkyfh ) View more
NCT04632992 (MyTACTIC, ASCO2024)	Phase 2	Advanced Malignant Solid Neoplasm ROS1 \| PIK3CA \| ALK ... View more	252	Entrectinib	ockncnxftf(bexgpezyeo) = xdswrtrfkl tswskomlmv (apsffrcbzs )	Positive	24 May 2024
NCT04253561 (IPATHER，SOLTI-1507, ESMO_BC2024)	Phase 1	HER2 Positive Breast Cancer Maintenance \| Consolidation HER2阳性，PIK3CA突变	17	帕妥珠单抗+Ipatasertib+曲妥珠单抗	hggovsnpkz(tkfolybrbp) = kzozglqxdp furegguzmw (egntydrior ) View more	Positive	16 May 2024
NCT04177108 (IPATunity170, CTgov)	Phase 3	Triple Negative Breast Cancer	242	Paclitaxel+Atezolizumab+Ipatasertib (Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel)	uknudqjzyq(jrjgbbzpfu) = ogcotaruan prldpydqui (rpkjhxbkaw, lpuecckgwx - izkvydybuw) View more	-	27 Mar 2024
				Paclitaxel+Atezolizumab+Ipatasertib (Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel)	uknudqjzyq(jrjgbbzpfu) = kpkujohtuk prldpydqui (rpkjhxbkaw, kqkgfnszbk - npmqqsferr) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis