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RECRUITINGPHASE1

A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors

A Phase 1, First-in-Human, Multicenter, Open-Label Study of ABSK131 to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Patients With MTAP-Deficient Advanced/Metastatic Solid Tumors

NCT07288957•Abbisko Therapeutics Co, Ltd

View on ClinicalTrials.gov

Summary

This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.

Detailed Description

The study will be started with a dose escalation part of ABSK131 administered in repeated 21-day cycles in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors. The expansion part of oral ABSK131 at the recommended dose of expansion (RDE) will be followed to evaluate safety, tolerability, and preliminary antitumor activity among patients with MTAP-Deficient Advanced/Metastatic Solid Tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Patients should understand, sign, and date the written informed consent form before screening.
•2\. Male or female aged 18 years or older.
•3\. Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumor; have received and progressed, are refractory or are intolerant to standard therapy or lack of standard therapy for the particular tumor type.
•4\. Patients with homozygous deletion of MTAP gene based on central testing or sponsor-accepted local report (depending on the availability of regional genetic testing), or with MTAP expression loss in the tumor based on the central testing.
•5\. Patients should provide archival tumor sample or undergo tumor biopsy at baseline if archival sample is not available or inadequate.
•6\. Backfill cohorts and expansion cohorts: Patients with 1 of the following cancers and have received no more than 3 prior lines of therapy。1)NSCLC；2) Pancreatic cancer；3)Esophageal cancer；4)Gastric cancer；5)Mesotheliomas.
•Food effect: a. Be able to eat a standardized high-fat meal within 30 minutes. b. Without primary GI tumors or metastasis.
•7\. Patients must have at least one measurable target lesion according to RECIST v1.1.
•8\. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
•9\. Life expectancy ≥3 months.
+3 more criteria

Exclusion Criteria

•1\. Known allergy or hypersensitivity to any component of ABSK131.
•2\. Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
•3\. Another active primary malignancy.
•4\. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction, or current evidence of GI disease that present with diarrhea. If any of these conditions exist, the sites' staff should discuss with the sponsor to determine patient eligibility.
•5\. Any of the situation within the specified time frame prior to the first administration of study drug.
•6\. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤ 1 severity (CTCAE v5.0) with the exception of which eligibility criteria allows, or alopecia, vitiligo, hypothyroidism stable on hormone replacement, or Grade 2 peripheral neurotoxicity.
•7\. Potent strong inhibitors or inducers of CYP3A family within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort); consumption of grapefruit juice, grapefruit hybrids, pomegranates, starfruits, pomelos, seville oranges or juice products within 3 days prior to the first dose of study treatment.
•8\. Proton pump inhibitors, such as omeprazole, lansoprazole, dexlansoprazole, or pantoprazole within 7 days before the first dose of study treatment.
•9\. Imaging (CT or MRI) showed tumor invasion of large blood vessels (such as aorta, pulmonary artery, pulmonary vein, vena cava, etc.) or risk of bleeding (such as esophageal and gastric varices).
•10.Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic) or symptomatic unstable brain metastases. Patients with a history of brain metastases have been treated and are stable ≥ 28 days may be enrolled. Patients with no steroid use for at least 2 weeks prior to the time of enrollment are permitted.
+10 more criteria

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

July 22, 2025

Primary Completion Date

December 30, 2028

Completion Date

July 30, 2029

Last Updated

December 17, 2025

Enrollment

266

ESTIMATED participants

Conditions

Solid Tumors (Phase 1)

Interventions

ABSK131

DRUG

Contacts

Ying Li

CONTACT

+86-21-68910052 ying.li@abbisko.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4

First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors

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