Phase l, First in Human, Multi-centre, Open-label, Clinical Trial of MPT0B640 in Subject with Locally Advanced or Metastatic Solid Malignancies
Phase I. Advanced or metastatic solid malignancy First in Human. HSP90 inhibitor Multi-center clinical trials. Open label.
To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640

Start Date01 Dec 2025

Sponsor / Collaborator

J INTS BIO

NCT06223542 / RecruitingPhase 1IIT

A Phase I Study to Investigate the Safety of the Ubiquitin Activating Enzyme Inhibitor TAK-243 in Adult Solid Tumor and Lymphoma Patients

This phase I trial studies the side effects and best dose of ubiquitin-activating enzyme (UAE) inhibitor TAK-243 (TAK-243) in treating patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) and in patients with lymphoma. TAK-243 is a drug that binds to and inhibits the ubiquitin-activating enzyme, an enzyme that is more active on cancer cells than healthy cells, inhibiting tumor cell proliferation and survival.

Start Date27 May 2025

Sponsor / Collaborator

National Cancer Institute

NCT06630416 / Not yet recruitingPhase 2IIT

A Phase II Trial to Evaluate Pemetrexed Response in Relation to Tumor Alterations of Gene Status in Patients With Previously Treated Metastatic Urothelial Carcinoma and Other Solid Tumors

This phase II trial tests how well pemetrexed works in treating patients with urothelial bladder cancer and other solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) with mutations that result in a loss of function in the MLL4-protein/KMT2D-gene or UTX-protein/KDM6A-gene or MTAP enzyme. Loss of function due to a genetic mutation means a gene's activity may be reduced or eliminated. Mutations that result in a loss of function in the MLL4-protein or KMT2D-gene are found in 9.96% of all cancers including bladder carcinoma patients, esophageal squamous cell carcinoma and esophageal adenocarcinoma patients. In addition, mutations that result in a loss of function in the UTX-protein or KDM6A-gene are found in approximately 5% of all tumors, including bladder cancers, endometrial cancer, and esophagogastric cancer amongst many other tumor types. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Giving pemetrexed may increase response in patients with metastatic urothelial bladder cancer and other solid tumors with the loss of function in the MLL4-protein/KMT2D-gene or UTX-protein/KDM6A-gene or MTAP enzyme.

Start Date10 May 2025

Sponsor / Collaborator

Northwestern University

[+1]

100 Clinical Results associated with Metastatic Solid Tumor

100 Translational Medicine associated with Metastatic Solid Tumor

0 Patents (Medical) associated with Metastatic Solid Tumor

1,073

Literatures (Medical) associated with Metastatic Solid Tumor

01 Dec 2024·International Journal of Cancer

Improving the clinical meaning of surrogate endpoints: An empirical assessment of clinical progression in phase III oncology trials

Article

Author: Msaouel, Pavlos ; Lin, Timothy A. ; Sherry, Alexander D. ; Abi Jaoude, Joseph ; Koay, Eugene J. ; Miller, Avital M. ; Kouzy, Ramez ; Thomas, Charles R. ; Fuller, Clifton David ; Kupferman, Gabrielle S. ; McCaw, Zachary R. ; Tang, Chad ; Passy, Adina H. ; Beck, Esther J. ; Ludmir, Ethan B.

AbstractDisease progression in clinical trials is commonly defined by radiologic measures. However, clinical progression may be more meaningful to patients, may occur even when radiologic criteria for progression are not met, and often requires a change in therapy in clinical practice. The objective of this study was to determine the utilization of clinical progression criteria within progression‐based trial endpoints among phase III trials testing systemic therapies for metastatic solid tumors. The primary manuscripts and protocols of phase III trials were reviewed for whether clinical events, such as refractory pain, tumor bleeding, or neurologic compromise, could constitute a progression event. Univariable logistic regression computed odds ratios (OR) and 95% CI for associations between trial‐level covariates and clinical progression. A total of 216 trials enrolling 148,190 patients were included, with publication dates from 2006 through 2020. A major change in clinical status was included in the progression criteria of 13% of trials (n = 27), most commonly as a secondary endpoint (n = 22). Only 59% of trials (n = 16) reported distinct clinical progression outcomes that constituted the composite surrogate endpoint. Compared with other disease sites, genitourinary trials were more likely to include clinical progression definitions (16/33 [48%] vs. 11/183 [6%]; OR, 14.72; 95% CI, 5.99 to 37.84; p < .0001). While major tumor‐related clinical events were seldom considered as disease progression events, increased attention to clinical progression may improve the meaningfulness and clinical applicability of surrogate endpoints for patients with metastatic solid tumors.

01 Nov 2024·Advances in Therapy

Efficacy and Safety of Iparomlimab, an Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors: A Phase 1c Study

Article

Author: Wang, Jianhua ; Yang, Mengxiang ; Wang, Zhongfeng ; Ouyang, Weiwei ; Niyazi, Huerxidan ; Chen, Yan ; Lou, Hanmei ; Li, Lingyan ; Kang, Xiaoyan ; Zhang, Baihui ; Xiong, Jianping ; Sun, Ping ; Gao, Zhenyuan ; Zhou, Huan ; Guo, Weijian ; Xu, Zhongyuan ; Zheng, Ling ; Liu, Ying ; Guo, Yabing

INTRODUCTIONIparomlimab (QL1604) is a humanized immunoglobulin G4 mAb against programmed cell death protein 1 (PD-1). Here, we report the preliminary efficacy, safety, pharmacokinetics, and immunogenicity of iparomlimab in patients with advanced solid tumors.METHODSIn this open-label, phase 1c study, patients with advanced or metastatic solid tumors, either failed or had no standard therapies available, were enrolled and received intravenous iparomlimab at 3 mg/kg once every 3 weeks. The primary efficacy endpoint was the objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.RESULTSBetween July 20, 2020, and September 6, 2021, 71 patients were enrolled and received at least one dose of iparomlimab. The ORR was 9.9% (7/71) and disease control rate was 36.6% (26/71). Median duration of response of all responders was 10.7 months [95% confidence interval (CI), 1.4-not estimable]. Additionally, the median time to progression, progression-free survival, and overall survival were 1.4 months (95% CI, 1.4-2.8), 1.4 months (95% CI, 1.4-2.7), and 9.7 months (95% CI, 7.2-15.3), respectively. A total of 52 (73.2%) patients experienced treatment-related adverse events (TRAEs) (grade ≥ 3, 19.7%). The most common TRAE (≥ 10%) was anemia (18.3%). A total of 20 (28.2%) experienced immune-related adverse events (grade ≥ 3, 7.0%). TRAEs leading to discontinuation of study drug occurred in 4 (5.6%) patients, including immune-mediated myocarditis (2 patients), Guillain-Barré syndrome (1 patient), and diarrhea (1 patient).CONCLUSIONSIparomlimab showed preliminary clinical activity and had a manageable safety profile in patients with advanced solid tumors. These results support further investigation of iparomlimab as monotherapy or in combination therapy in advanced solid tumors.TRIAL REGISTRATIONClinicalTrials.gov identifier, NCT05801094. Retrospectively registered in 2023-03-24.

10 Oct 2024·Journal of Clinical Oncology

Efficacy and Safety of Sacituzumab Govitecan in Patients With Advanced Solid Tumors (TROPiCS-03): Analysis in Patients With Advanced Endometrial Cancer

Article

Author: Butrynski, James ; Santin, Alessandro D. ; Kuo, Peiwen ; Willmott, Lyndsay ; Patel, Jilpa ; Tse, Ka Yu ; Spira, Alexander ; Wu, Tia ; Mekan, Sabeen ; Corr, Bradley R. ; Lin, Kai-Wen ; Dumbrava, Ecaterina E.

PURPOSEPatients with advanced endometrial cancer (EC) who progress on or after platinum-based therapy and immunotherapy have poor prognosis. We report efficacy and safety of sacituzumab govitecan (SG), a trophoblast cell-surface antigen 2 (Trop-2)–directed antibody-drug conjugate, in patients with advanced EC.METHODS TROPiCS-03 (ClinicalTrials.gov identifier: NCT03964727 ) is a multicohort, open-label, phase II basket study in patients with metastatic solid tumors. Eligible patients in the EC cohort received SG 10 mg/kg once on days 1 and 8 every 3 weeks. Primary end point was objective response rate (ORR) by investigator's assessment per RECIST v1.1. Secondary end points included clinical benefit rate (CBR; complete and partial response, and stable disease ≥6 months), duration of response (DOR), and progression-free survival (PFS) per investigator assessment, overall survival, and safety. Trop-2 expression of archival or baseline tumor specimens was analyzed by immunohistochemistry. RESULTSAt data extraction date, 41 patients were enrolled. Median follow-up was 5.8 months (range, 0.7-19.3); median previous therapies was three (range, 1-6); and 85% of patients received previous chemotherapy and immunotherapy. ORR was 22% (95% CI, 11 to 38); CBR was 32% (95% CI, 18 to 48). Median DOR was 8.8 months (95% CI, 2.8 to not estimable); median PFS was 4.8 months (95% CI, 2.8 to 9.8). Trop-2 exploratory analysis was conducted retrospectively for 39 patients. Tumor Trop-2 protein was highly expressed in EC, showing limited correlation with efficacy. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 73% of patients. Study drug discontinuation due to TRAEs was 5%. Two deaths occurred, deemed unrelated to SG.CONCLUSIONFindings from TROPiCS-03 showed encouraging efficacy of SG with a manageable toxicity profile in a heavily pretreated population with advanced EC. Safety findings were consistent with the known SG safety profile.

483

News (Medical) associated with Metastatic Solid Tumor

24 Oct 2024

·www.biospace.com

NiKang Therapeutics® Presents Discovery of NKT3964, a First-in-Class, Highly Potent and Selective, Orally Bioavailable CDK2 PROTAC Degrader for Cancer Therapy, at the EORTC-NCI-AACR Symposium 2024

- NKT3964 is a first-in-class, highly potent and selective CDK2 degrader, and causes prolonged CDK2 pathway inhibition without cyclin E accumulation - NKT3964 is designed to treat patients with cyclin E driven cancers WILMINGTON, Del.--(BUSINESS WIRE)--NiKang Therapeutics ® Inc. (“NiKang”) is a clinical stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need. The company announced today the unveiling of NKT3964 at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (“Triple Meeting”) during a Poster Spotlight Session. The conference is being held October 23-25, 2024, in Barcelona, Spain. NKT3964 is a first-in-class, orally bioavailable small molecule CDK2 degrader that selectively degrades CDK2, demonstrating high specificity over CDK1 and other CDK family members. Its high potency and unique mechanism of action result in sustained inhibition of CDK2 pathway without causing cyclin E accumulation. NKT3964 is designed to treat patients with aberrant CDK2/cyclin E pathway activation, including those with ovarian, endometrial, gastric and HR+HER2- breast cancers. NiKang has initiated a phase 1, open-label, dose escalation study of NKT3964 as a single agent. This first-in-human study (NCT06586957) is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion of NKT3964 in adults with advanced or metastatic solid tumors. “We are excited to share the discovery of NKT3964, a first-in-class oral CDK2 degrader at this year’s Triple Meeting,” said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. “This is the second of three programs targeting the cell cycle (CDK2 inhibitor NKT3447, CDK2 degrader NKT3964, and a CDK2/4 selective dual degrader) that we have advanced to the clinic. We believe CDK2 plays a critical role in driving tumor growth. Recent clinical data presented at ESMO further validates CDK2 as a key oncology target. We are developing a cutting-edge portfolio of CDK2 and CDK2/4 degraders that can achieve sustained CDK pathway inhibition while avoiding paradoxical cyclin E increase. Our multi-pronged approach allows us to thoroughly and deeply interrogate this pathway. We look forward to exploring NKT3964’s potential in treating patients with advanced or metastatic solid tumors.” Poster Presentation Details: Title: Discovery of NKT3964: a first-in-class, highly potent and selective, orally bioavailable CDK2 PROTAC degrader for cancer therapy Presenter: Jianlin Geng, Ph.D. Abstract Number: PB002 Session: Posters in the Spotlight Date/Time: 2:00 p.m.-2:40 p.m. CEST on October 24, 2024 About NKT3964 NKT3964 is a first-in-class, highly potent and selective, orally bioavailable CDK2 PROTAC degrader, causing prolonged CDK2 pathway inhibition without cyclin E accumulation. It has the potential to maximally inhibit the CDK2 pathway, fully harnessing the therapeutic benefits of CDK2 inhibition. NKT3964 is currently under evaluation in a Phase 1 clinical study in advanced or metastatic solid tumors as a single agent (NCT06586957). About NiKang Therapeutics NiKang Therapeutics is a clinical-stage biotech company focused on discovering and developing innovative small molecule oncology medicines to bring transformative therapies to patients in need. Our target selection is driven by deep insight into disease biology and molecular pathways. Our discovery approach is informed by target structure biology and capitalizes on structure-based drug design. The successful implementation of our strategy enables us to rapidly and efficiently discover and advance proprietary drug candidates with the most desirable pharmacological features into clinical studies. We have successfully advanced three programs into clinical trials, including NKT2152 (HIF2α), NKT3447 (CDK2), and NKT3964 (CDK2). For more information, please visit Contacts Kelsey Chen Chief Financial and Operating Officer IR@nikangtx.com

Phase 1AACR

23 Oct 2024

·www.globenewswire.com

TransCode Therapeutics Announces Safety Review Committee Approval of Second Cohort Opening in Phase 1 TTX-MC138 Clinical Trial Following Favorable Review of Cohort 1 Safety Data

The clinical trial Safety Review Committee (SRC) approved opening of Cohort 2 after review of safety data from the three patients comprising Cohort 1No significant safety or dose limiting toxicities have been reported in Cohort 1Patients are currently being evaluated for eligibility in Cohort 2TTX-MC138 is a therapeutic candidate based on microRNAmicroRNA technology was recognized with the 2024 Nobel Prize in Physiology and MedicineTransCode is the only company with an ongoing US clinical trial targeting microRNA in cancer BOSTON, Oct. 23, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced that the Safety Review Committee (SRC) monitoring its Phase 1 clinical trial has unanimously approved opening of the second cohort of patients based on its favorable review of Cohort 1 safety data. The therapeutic candidate being evaluated, TTX-MC138, is TransCode’s lead candidate designed to inhibit microRNA-10b, a microRNA critical to the emergence and progression of metastatic cancer. All patients in the first cohort remain on study for continued treatment. No significant safety or dose limiting toxicities have been reported. The dose administered to the second cohort will be approximately double the dose administered to the first cohort. “An SRC is a group of clinicians and experts that oversee the safety of subjects during the conduct of the trial. The SRC makes decisions on whether and how the study should proceed, including dose escalation and de-escalation decisions per the study design. The recommendations of the SRC are used to decide whether a clinical trial should be continued as designed, changed, or terminated,” commented Sue Duggan, TransCode’s Senior Vice President of Operations. Duggan added, “No dose-limiting toxicities were reported in the first cohort of patients treated with TTX-MC138. Eligible subjects may now be scheduled in Cohort 2 for treatment with the next dose level of TTX-MC138.” About TTX-MC138 TTX-MC138 is a first-in-class therapeutic candidate that targets microRNA-10b, a micro-RNA widely believed to be a driver of metastatic disease. TransCode’s 2023 Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions and pharmacodynamic activity, even at a microdose of the drug candidate, suggesting a broad therapeutic window for TTX-MC138. About the Trial TransCode’s Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study, designed to generate critical data to support evaluation of the safety and tolerability of TTX-MC138 in patients with a variety of metastatic solid cancers. While not an endpoint, the trial may provide early evidence of clinical activity of TTX-MC138. The trial comprises an initial dose-escalation phase followed by a dose-expansion phase. The primary objective of the dose-escalation phase is to evaluate the safety and tolerability of escalating dose levels of TTX-MC138. In the dose-expansion phase, the safety, tolerability and anti-tumor activity of TTX-MC138 will be further evaluated in certain tumor types selected based on preliminary results from the dose-escalation phase. Further information is available at www.clinicaltrials.gov NCT Identifier: (NCT06260774). About TransCode Therapeutics TransCode is a clinical-stage oncology company focused on treating metastatic disease. The company is committed to defeating cancer through the intelligent design and effective delivery of RNA therapeutics based on its proprietary TTX nanoparticle platform. The company’s lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors which overexpress microRNA-10b, a unique, well-documented biomarker of metastasis. In addition, TransCode is developing a portfolio of other first-in-class RNA therapeutic candidates designed to overcome the challenges of RNA delivery and thus unlock therapeutic access to a variety of novel genetic targets that could be relevant to treating a variety of cancers. Forward-Looking Statements This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the timing, conduct and results of the Phase 1 clinical trial, statements about microRNAs and their involvement in cancer, and statements concerning the therapeutic potential of TransCode’s TTX-MC138. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risks associated with drug discovery and development; the risk that the results of clinical trials will not be consistent with TransCode’s pre-clinical studies or expectations or with results from previous clinical trials; risks associated with the conduct of clinical trials; risks associated with TransCode’s financial condition and its need to obtain additional funding to support its business activities, including TransCode’s ability to continue as a going concern; risks associated with the timing and outcome of TransCode’s planned regulatory submissions; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with TransCode’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; risks of competition from other companies developing products for similar uses; risks associated with TransCode’s dependence on third parties; and risks associated with geopolitical events and pandemics, including the COVID-19 coronavirus and military actions. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause TransCode’s actual results to differ from those contained in or implied by the forward-looking statements, see the section entitled “Risk Factors” in TransCode’s Annual Report on Form 10-K for the year ended December 31, 2023, as well as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the Securities and Exchange Commission. All information in this press release is as of the date of this release; TransCode undertakes no duty to update this information unless required by law. For more information, please contact: TransCode Therapeutics, Inc. Tania Montgomery-Hammon, VP of Business Development tania.montgomery@transcodetherapeutics.com

Phase 1Clinical Result

22 Oct 2024

·www.biospace.com

SOTIO Announces Upcoming Poster Presentations at the 2024 SITC Annual Meeting

PRAGUE & BASEL, Switzerland & BOSTON--(BUSINESS WIRE)-- SOTIO Biotech , a clinical-stage immuno-oncology company owned by PPF Group, today announced it will present three posters at the 2024 Society for Immunotherapy of Cancer Meeting taking place November 6 - 10, 2024, in Houston, TX. Data to be presented include the investigation of a novel chimeric PGC-1α transgene to enhance CAR T cell efficacy in patients with solid tumors. The VICTORIA-01 study is currently evaluating the safety, tolerability and initial efficacy of SOT201 monotherapy for the treatment of advanced solid tumors, as well as data around SOT201, a next-generation clinical stage PD-1-targeting immunocytokine. Poster details are as follows: Title: “Chimeric PGC-1α expression in CAR-T cells improves metabolic function and anti-tumor efficacy in solid tumors” Abstract Number: 273 Date: Thursday, November 7 and Friday, November 8, 2024 Presenting Author: Amy Jensen-Smith Title: “VICTORIA-01: A multicenter, open-label, phase 1 study to evaluate the safety and preliminary efficacy of SOT201 in patients with advanced or metastatic solid tumors” Abstract Number: 675 Date: Friday, November 8, 2024 Presenting Author: Aung Naing Title: “SOT201, a novel cis-acting PD-1/IL-15 mutein-based immunocytokine that reinvigorates anti-tumor immunity qualitatively superior to PD-1/IL-2v-based IL-2/15Rβγ agonism” Abstract Number: 940 Date: Saturday, November 9, 2024 Presenting Author: Irena Adkins Presentation materials will be available after presentations conclude here . About SOTIO Biotech SOTIO Biotech (SOTIO) is shaping the future of targeted cancer therapies by translating compelling science into patient benefit. The SOTIO pipeline includes three clinical-stage programs: SOT102, a next-generation Claudin-18.2-targeted antibody-drug conjugate; BOXR1030, a metabolically-enhanced CAR-T cell therapy targeting GPC3-expressing tumors; and SOT201, a next-generation PD-1-targeting immunocytokine. SOTIO is a member of the PPF Group. For more information, please visit the company’s website at . SOTIO is a registered trademark of SOTIO Biotech a.s. in selected countries. Contacts Company contact: Richard Kapsa Head of Communication T: (+420) 224 174 448 M: (+420) 603 280 971 kapsa@sotio.com Media contact: Lisa Raffensperger Ten Bridge Communications M: +1 (617) 903-8783 lisa@tenbridgecommunications.com

ImmunotherapyPhase 1Cell TherapyAACR

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