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

NCT07288957 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ABSK131-101
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumors (Phase 1)

Keywords

ABSK131; MTAP; PRMT5

Outcome Measures

Primary Outcomes (4)

• Incidence of DLT

  Dose-limiting toxicities

  from Run-in to Day21

• AEs

  Adverse events

  The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months.

• AESIs

  Adverse events of special interest (AESIs)

  he date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months.

• SAEs

  Serious adverse events (SAEs)

  The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months

Secondary Outcomes (10)

• Cmax

  From date of enrollment（Run-） until the date of end of treatment visit, assessed up to 30 months

• AUC

  From date of enrollment（R） until the date of end of treatment visit, assessed up to 30 months

• t1/2

  From date of enrollment（Run-in） until the date of end of treatment visit, assessed up to 30 months

• CL/F

  From date of enrollment（Run-in） until the date of end of treatment visit, assessed up to 30 months

• tmax

  From date of enrollment（R） until the date of end of treatment visit, assessed up to 30 months

Study Arms (1)

Escalation and expansion part

EXPERIMENTAL

No more than 86 patients are anticipated to be enrolled in the escalation part. No more than 180 patients will be enrolled in the expansion part

Drug: ABSK131

Interventions

ABSK131 DRUG

In the escalation part，patients will first orally receive a single dose of ABSK131 on D-2, followed by a two-day run-in period to assess the PK profile of single-dose ABSK131 administration. Thereafter, patients will continuously receive ABSK131 once daily (QD). In the expansion part， patients will orally receive ABSK131 at the recommended dose for expansion (RDE)

Escalation and expansion part

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients should understand, sign, and date the written informed consent form before screening.
• \. Male or female aged 18 years or older.
• \. 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.
• \. 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.
• \. Patients should provide archival tumor sample or undergo tumor biopsy at baseline if archival sample is not available or inadequate.
• \. 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.
• \. Patients must have at least one measurable target lesion according to RECIST v1.1.
• \. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• \. Life expectancy ≥3 months.
• Adequate organ function and bone marrow function as indicated by the screening assessments performed within 14 days prior to the first dose of study drug.
• Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the first dose.
• Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control from signing the informed consent to approximately 6 months after the last dose of study drug. A condom is also required to be used by vasectomized men to prevent delivery of the drug via seminal fluid.

You may not qualify if:

• \. Known allergy or hypersensitivity to any component of ABSK131.
• \. Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
• \. Another active primary malignancy.
• \. 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.
• \. Any of the situation within the specified time frame prior to the first administration of study drug.
• \. 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.
• \. 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.
• \. Proton pump inhibitors, such as omeprazole, lansoprazole, dexlansoprazole, or pantoprazole within 7 days before the first dose of study treatment.
• \. 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).
• 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.
• Impaired cardiac function or clinically significant cardiac disease.
• Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1/2 antibody.
• Patients with ascites or pleural effusion, or pericardial effusion which is refractory/uncontrolled, or requiring the intervention within 2 weeks prior to the first dose.
• Confirmed or suspected ILD/pneumonitis or history of (non-infectious) ILD/pneumonitis that required oral or IV steroids or supplemental oxygen.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test within 7 days prior to the start of study drug.

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 201210, China

RECRUITING

Central Study Contacts

Ying Li

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 17, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): July 30, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)