A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

Start Date16 Nov 2023

Sponsor / Collaborator

Olema Pharmaceuticals, Inc.

NCT05508906 / RecruitingPhase 1

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, or With the mTOR Inhibitor Everolimus in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows:
Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation).
Treatment Group 3: OP-1250 in combination with everolimus.

Start Date31 Aug 2022

Sponsor / Collaborator

Olema Pharmaceuticals, Inc.

[+1]

ACTRN12621001419853 / RecruitingPhase 1

A Phase 1 Dose Escalation and Dose Expansion Open-label, Multicenter, Study of OP-1250 in Combination with the CDK4/6 Inhibitor Palbociclib in Adult Subjects with Advanced or Metastatic HR-positive, HER2-negative Breast Cancer

Start Date03 Feb 2022

Sponsor / Collaborator

Olema Pharmaceuticals, Inc.

100 Clinical Results associated with Palazestrant

100 Translational Medicine associated with Palazestrant

100 Patents (Medical) associated with Palazestrant

Literatures (Medical) associated with Palazestrant

04 Mar 2024·Molecular cancer therapeutics

Palazestrant (OP-1250), A Complete Estrogen Receptor Antagonist, Inhibits Wild-type and Mutant ER-positive Breast Cancer Models as Monotherapy and in Combination

Article

Author: Barratt, Susanna A ; Sun, Richard ; Hodges-Gallagher, Leslie ; Peña, Guadalupe ; Myles, David C ; Ortega, Fabian E ; Palanisamy, Gopinath S ; Parisian, Alison D ; Kulp, David ; Robello, Brandon ; Kushner, Peter J ; Harmon, Cyrus L ; Sapugay, Judevin

Abstract:

The estrogen receptor (ER) is a well-established target for the treatment of breast cancer, with the majority of patients presenting as ER-positive (ER+). Endocrine therapy is a mainstay of breast cancer treatment but the development of resistance mutations in response to aromatase inhibitors, poor pharmacokinetic properties of fulvestrant, agonist activity of tamoxifen, and limited benefit for elacestrant leave unmet needs for patients with or without resistance mutations in ESR1, the gene that encodes the ER protein. Here we describe palazestrant (OP-1250), a novel, orally bioavailable complete ER antagonist and selective ER degrader. OP-1250, like fulvestrant, has no agonist activity on the ER and completely blocks estrogen-induced transcriptional activity. In addition, OP-1250 demonstrates favorable biochemical binding affinity, ER degradation, and antiproliferative activity in ER+ breast cancer models that is comparable or superior to other agents of interest. OP-1250 has superior pharmacokinetic properties relative to fulvestrant, including oral bioavailability and brain penetrance, as well as superior performance in wild-type and ESR1-mutant breast cancer xenograft studies. OP-1250 combines well with cyclin-dependent kinase 4 and 6 inhibitors in xenograft studies of ER+ breast cancer models and effectively shrinks intracranially implanted tumors, resulting in prolonged animal survival. With demonstrated preclinical efficacy exceeding fulvestrant in wild-type models, elacestrant in ESR1-mutant models, and tamoxifen in intracranial xenografts, OP-1250 has the potential to benefit patients with ER+ breast cancer.

News (Medical) associated with Palazestrant

10 Dec 2024

·www.globenewswire.com

Olema Oncology Presents Updated Clinical Results for Palazestrant in Combination with Ribociclib at the San Antonio Breast Cancer Symposium

Palazestrant, in combination with ribociclib, demonstrated promising clinical activity, a safety profile consistent with ribociclib and endocrine therapy, and favorable tolerability in patients with ER+/HER2- advanced or metastatic breast cancer With a median follow-up of 12 months, median progression-free survival (PFS) has not been reached6-month PFS rate was 73% in all patients, 81% in patients with ESR1 mutations, 70% in ESR1 wild-type patients, and 68% in patients with prior CDK4/6 inhibitor treatment; data continue to mature Conference call today at 8:00 a.m. ET SAN FRANCISCO, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced updated clinical results from the ongoing Phase 1b/2 study of palazestrant in combination with CDK4/6 inhibitor, ribociclib, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer. Results as of September 25, 2024, will be presented in a poster session at the San Antonio Breast Cancer Symposium (SABCS 2024) being held December 10-13 at the Henry B. Gonzalez Convention Center in San Antonio, Texas. Updated results as of November 11, 2024, are detailed below. “We believe these data, while still maturing, are compelling and highly differentiated, with robust clinical activity shown across both ESR1 wild-type and mutant patient populations after prior treatment with a CDK4/6 inhibitor in combination with endocrine therapy. Mutations in the ESR1 gene are one of the most common resistance mechanisms arising during current front-line standard of care treatment, leading to progression. Palazestrant has demonstrated its potential to work in combination with ribociclib by completely blocking estrogen receptor signaling and suppressing tumor growth to extend progression-free survival after prior progression on the current standard of care, regardless of ESR1 status,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “These data provide the foundation to initiate OPERA-02, our planned pivotal Phase 3 trial of palazestrant in combination with ribociclib in front-line metastatic breast cancer next year. We look forward to sharing mature data from this combination in 2025 and continuing the development of palazestrant as we work to advance our goal of creating innovative therapies to improve the lives of breast cancer patients.” Interim Results from the Phase 1b/2 Study of Palazestrant in Combination with RibociclibEnrollment62 patients with advanced or metastatic ER+/HER2- breast cancer were treated with palazestrant (n=56 at the recommended Phase 2 dose (RP2D) of 120 mg once daily) plus ribociclib (600 mg once daily; three weeks on treatment followed by one week off treatment). The majority of participants (48 (77%)) were 2/3+ line patients; 48 (77%) patients received prior endocrine therapy for metastatic breast cancer, 46 (74%) patients received prior treatment of endocrine therapy with CDK4/6 inhibitors (CDK4/6i), 12 (19%) received two prior lines of treatment with CDK4/6i, and 11 (18%) patients received chemotherapy for metastatic breast cancer.36 (58%) patients had visceral disease; 42 (68%) patients had measurable disease at baseline. Of 60 patients whose circulating tumor DNA (ctDNA) was assessed, 28% had activating mutations in ESR1 at baseline. EfficacyPalazestrant combined with ribociclib showed promising clinical activity including tumor responses, prolonged disease stabilization, and progression-free survival in patients with ESR1 wild-type and ESR1 activating mutations at baseline and in those previously treated with one or two lines of CDK4/6i. Efficacy data continue to mature; 30 (48%) patients remain on treatment, and the longest duration on treatment is approximately 18 months (79 weeks) and was ongoing as of the data cutoff date of November 11, 2024. With a median follow-up of 12 months, the median PFS was not reached as of the data cutoff date. Across all patients, the 6-month PFS rate was 73%. In those who received prior treatment with a CDK4/6i plus an endocrine therapy, the 6-month PFS rate was 68%. The 6-month PFS rate in ESR1 mutant patients was 81% and in ESR1 wild-type patients it was 70%.In those who were clinical benefit rate (CBR)1-eligible, the CBR was 76% (37/49) in all patients, 81% (13/16) in patients with ESR1 mutations, and 74% (23/31) in ESR1 wild-type patients. In patients with prior CDK4/6i treatment, the CBR was 71% (25/35), 81% (12/16) in patients with ESR1 mutations, and 65% (11/17) in ESR1 wild-type patients.As of the data cutoff date, there were 11 responses (two confirmed complete responses, eight confirmed partial responses, and one unconfirmed partial response). Among 37 response-evaluable patients with measurable disease, the ORR was 27% (10/37). 60% of the 37 had a reduction in target lesion size. Safety and TolerabilityAcross 62 treated patients, the combination of up to 120 mg of palazestrant with the approved dose for metastatic disease of 600 mg of ribociclib daily was well tolerated with no new safety signals or increase in toxicity. The overall safety profile was consistent with the established safety profile of ribociclib 600 mg plus an endocrine therapy. Treatment with palazestrant up to 120 mg combined with ribociclib (600 mg) was well tolerated with no dose-limiting toxicities.The majority of treatment-emergent adverse events (TEAEs) were Grade 1 or 2, and the severity and incidence of adverse events were consistent with the expected safety profile of ribociclib plus endocrine therapy. PharmacokineticsPalazestrant did not affect ribociclib drug exposure when compared with published exposure data for single-agent ribociclib. Steady-state trough values showed no clinically significant difference between the combination and single-agent palazestrant. ConclusionsFindings from this study support the advancement of palazestrant in combination with ribociclib into clinical development for the first-line treatment of ER+/HER2- advanced or metastatic breast cancer. “Palazestrant is not an endocrine therapy where you need to wait six months to see a patient derive benefit. We have seen impressive responses quickly and a significant reduction of disease burden. The patients I have seen feel much better than they have on other treatments available in the armamentarium today,” said Virginia Borges, M.D., Professor, Medicine-Medical Oncology at the University of Colorado, and Principal Investigator for the palazestrant plus ribociclib combination study. “The findings presented at SABCS show that the combination of palazestrant and ribociclib is well-tolerated with meaningful preliminary efficacy that I believe has the potential to outperform the current standard of care and change how metastatic breast cancer is treated. I look forward to the continued development of palazestrant.” A copy of the poster presented at SABCS reflecting a September 25, 2024 data cutoff date will be made available on the Publications page of Olema’s website in alignment with the Symposium’s embargo policy. 1CBR is the proportion of patients who remained on treatment through at least 24 weeks with a confirmed complete response or partial response, or stable disease. Conference Call InformationOlema will hold a conference call to discuss these results today with the investment community at 8:00 a.m. ET (7:00 a.m. CT). Register to join the webcast by visiting the Events and Presentations page on the Investors section of Olema’s website. About Palazestrant (OP-1250)Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In preclinical studies, palazestrant completely blocks ER-driven transcriptional activity in both ESR1 wild-type and mutant forms of breast cancer. In Olema’s ongoing clinical trials for advanced or metastatic ER+/HER2- breast cancer, palazestrant has demonstrated anti-tumor activity along with attractive pharmacokinetics and exposure, favorable tolerability, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus). For more information on OPERA-01, please visit www.opera01study.com. About Olema OncologyOlema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), currently in a Phase 3 clinical trial called OPERA-01. In addition, Olema is developing a potent KAT6 inhibitor (OP-3136). Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com. Forward Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “may,” “potential,” “upcoming,” “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential beneficial characteristics, safety, tolerability, efficacy, and therapeutic effects of palazestrant and the development of palazestrant, in each case, including in combination with other drugs, the potential of palazestrant to work in combination with ribociclib to suppress tumor growth or extend progression-free survival, the initiation and timing of clinical trials, and Olema’s potential to transform the endocrine therapy standard of care treatments for patients living with ER+/HER2- metastatic breast cancer. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and other filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Media and Investor Relations ContactCourtney O’KonekVice President, Corporate CommunicationsOlema Oncologymedia@olema.com

Clinical ResultPhase 3Fast TrackPhase 2

10 Dec 2024

·endpts.com

Olema Oncology makes case for its oral SERD with fresh data cut from early breast cancer trial

Olema Oncology unveiled new data from a Phase 1b/2 breast cancer trial on Tuesday, as it strives to catch up with other companies with oral selective estrogen receptor degraders (SERDs). Olema’s vision is to co-administer palazestrant with front-line standard-of-care CDK4/6 inhibitors, such as Novartis’ Kisqali, in patients with advanced or metastatic ER-positive, HER2-negative breast cancer. The company says giving patients this combination could limit resistance to CDK4/6 inhibitors. Several companies, including Eli Lilly and Pfizer in partnership with Arvinas, are also at this year’s San Antonio Breast Cancer Symposium to report data from their respective oral SERDs. The new cut from Olema’s open-label trial focuses on 62 patients. After a year, the median progression-free survival had not been reached at the data cutoff of November 11, the company said. Among all patients, the six-month PFS rate was 73%, and 68% among those who received prior CDK4/6 plus endocrine therapy. The company said that palazestrant is a complete estrogen receptor antagonist as well as a SERD, and can thus treat both ESR1 mutated patients, in whom SERDs work best, and wild-type patients. Among ESR1-mutant patients, the six-month PFS rate was 81%. Importantly, it was 70% in wild-type patients, which is a “huge differentiator,” Olema CEO Sean Bohen told Endpoints News. “[We have shown] post CDK4/6, with the predominant population being wild type, what appears to be a very favorable PFS,” Bohen said. The palazestrant/Kisqali regimen could capture benefits across the whole patient population, which would be “a unique opportunity,” he said. Olema also disclosed two confirmed complete responses, eight confirmed partial responses and one unconfirmed partial response, giving an overall response rate of 27% among 37 response-evaluable patients with measurable disease. Patients in the trial had received palazestrant at increasing doses of up to 120 mg once daily, plus Kisqali. Bohen said 48 patients (77%) were second-, third- or later-line, and the rest were “previously untreated in the advanced or metastatic setting.” Perhaps the best comparators for Olema’s Tuesday data are those from the academic MAINTAIN trial. That study recruited patients with prior CDK4/6 treatment, 82% of whom were given AstraZeneca’s Faslodex, an endocrine therapy, plus Kisqali. In the overall MAINTAIN population, the six-month PFS rate was 41% and the mPFS was 5.3 months. Olema’s data clearly beat these. “The median follow-up [for Olema’s SERD] was 12 months and we’re still not at the median PFS,” Bohen said. “When do we hit that? We don’t know.” An earlier cut from this Phase 1b/2 trial, up to September 25, will be presented at the San Antonio Breast Cancer Symposium on Wednesday. Next year, Olema will kick off the pivotal OPERA-2 trial of the palazestrant/Kisqali combo in the first-line setting, and last week secured a supply of Novartis’s drug. However, other SERDs are already well into Phase 3 development in frontline disease. Expectations are particularly high for Roche’s giredestrant, whose PersevERA trial in combination with Pfizer’s CDK4/6 inhibitor Ibrance could report next year. Elsewhere, Olema is currently conducting a Phase 3 study, OPERA-1, of palazestrant monotherapy in second-line ER-positive, HER2-negative breast cancer, which Bohen said could lead to the monotherapy’s approval as second- and third-line therapy.

Phase 3Clinical ResultASCO

09 Dec 2024

·www.globenewswire.com

Olema Oncology Announces FDA Clearance of Investigational New Drug Application for OP-3136, a Potent KAT6 Inhibitor

Phase 1 clinical trial for OP-3136 to initiate in early 2025 SAN FRANCISCO, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OP-3136, a novel small molecule that potently and selectively inhibits KAT6, a validated epigenetic target that is dysregulated in breast and other cancers. "We are very pleased to have received notification from the FDA that OP-3136 may proceed into the clinic,” said David C. Myles, Ph.D., Chief Discovery and Non-Clinical Development Officer of Olema Oncology. “The compelling activity demonstrated by OP-3136 in preclinical models both as a single agent and in combination with palazestrant has generated strong investigator interest in OP-3136. We expect to initiate the Phase 1 clinical trial early next year and are excited by OP-3136’s potential in breast cancer and beyond.” About Olema OncologyOlema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), currently in a Phase 3 clinical trial called OPERA-01. In addition, Olema is developing a potent KAT6 inhibitor (OP-3136). Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com. Forward Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “may,” “potential,” “upcoming,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the advancement of OP-3136 into clinical development, including timelines for initiation and enrollment, the combinability of OP-3136 with other drugs and potential beneficial characteristics of OP-3136 as a monotherapy and in combination with other drugs. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and other filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Media and Investor Relations ContactCourtney O’KonekVice President, Corporate CommunicationsOlema Oncologymedia@olema.com

INDPhase 1Phase 3Phase 2

100 Deals associated with Palazestrant

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	US	Olema Pharmaceuticals, Inc.	16 Nov 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	AR	Olema Pharmaceuticals, Inc.	16 Nov 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	AU	Olema Pharmaceuticals, Inc.	16 Nov 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	BE	Olema Pharmaceuticals, Inc.	16 Nov 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	BR	Olema Pharmaceuticals, Inc.	16 Nov 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	BG	Olema Pharmaceuticals, Inc.	16 Nov 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	CA	Olema Pharmaceuticals, Inc.	16 Nov 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	CZ	Olema Pharmaceuticals, Inc.	16 Nov 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	FR	Olema Pharmaceuticals, Inc.	16 Nov 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	DE	Olema Pharmaceuticals, Inc.	16 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05508906 (ESMO_BC2024) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer First line HER2 Negative \| ER Positive	33	palazestrant+ribociclib	lgbkwurynf(rzdxfqygbr) = The most common (≥25%) were nausea, neutropenia (G4: 2 pts; 6%), WBC count decreased, fatigue, anemia, and diarrhea. Most TEAEs were grade 1-2 and consistent with the known safety profiles of each drug. ardhmuqyjx (lksdxolojw )	Positive	16 May 2024
GlobeNewswire Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer ESR1 Mutation \| ER Positive \| HER2 Negative	46	palbociclib 125 mg+palazestrant 120 mg	vivklitdlw(cpkkysvevz) = There was no observed drug-drug interaction between palazestrant and palbociclib, and there was no induced metabolism or increase in exposure of either palbociclib or palazestrant when administered in combination. dszdoghvro (owkvayzwcp ) View more	Positive	05 Dec 2023
				palbociclib 125 mg+palazestrant 120 mg (ESR1 mutation)
GlobeNewswire Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer HER2 Negative \| ER Positive	19	Ribociclib 600 mg+Palazestrant 120 mg	udnytklorb(avpbyfvdbu) = well tolerated, with no safety signals or enhancement of toxicity and an overall safety profile remains consistent with the expected safety profile of ribociclib plus an endocrine therapy. cvgpfesxya (tlarldephz ) View more	Positive	05 Dec 2023
NCT04505826 (ESMO2023) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer ER Positive \| HER2 Negative	86	OP-1250 120 mg	buojwwtzmk(wivjmybfwl) = nausea, vomiting, neutropenia, fatigue, headache, constipation, and diarrhea dwdwnpxrnq (nswtbsryye ) View more	Positive	22 Oct 2023
				OP-1250 120 mg (ESR1 mutation)
NCT04505826 (ENA2022) Manual	Phase 1	ER-positive/HER2-negative Breast Cancer ER positive \| HER2 negative	37	OP-1250 (60mg)	ahgsbwvpsm(rimodusgsn) = The most common treatment emergent adverse events reported (≥10%) in Phase 1b in the 60 mg/120 mg cohorts were nausea (28%/21%), vomiting (17%/16%), fatigue (17%/5%) and headache (11%/ 11%). gvnatpkifh (pajmrfuxue ) View more	Positive	28 Oct 2022
				OP-1250 (120mg)
NCT04505826 (Biospace) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer ER positive \| HER2 negative	-	OP-1250	tkqflilfzm(omgxkmprfd) = nnjxizfmwo pmifnhsyuv (mxkbjxxpnf ) View more	Positive	30 Nov 2021

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

Chat with Hiro

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

Palazestrant

Overview

Basic Info

Structure

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation