Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07288957

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

Led by Abbisko Therapeutics Co, Ltd · Updated on 2025-12-17

266

Participants Needed

1

Research Sites

209 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must understand and sign the informed consent form before screening.
  • Male or female aged 18 years or older.
  • Histologically or cytologically confirmed metastatic or locally advanced solid tumor.
  • Disease progressed, refractory, or intolerant to standard therapy or lack of standard therapy for the tumor type.
  • Homozygous deletion of MTAP gene by central or sponsor-accepted local testing, or MTAP expression loss in tumor by central testing.
  • Provide archival tumor sample or undergo baseline tumor biopsy if archival sample is unavailable or inadequate.
  • For expansion cohorts, patients must have one of these cancers and no more than 3 prior therapy lines: NSCLC, pancreatic, esophageal, gastric cancer, or mesotheliomas.
  • Ability to eat a standardized high-fat meal within 30 minutes; no primary gastrointestinal tumors or metastasis.
  • At least one measurable target lesion per RECIST v1.1.
  • ECOG performance status 0 or 1.
  • Life expectancy of at least 3 months.
  • Adequate organ and bone marrow function per assessments within 14 days before first dose.
  • Controlled blood pressure 60;150/90 mmHg at screening; stable antihypertensive medications for at least 1 week before first dose.
  • Non-surgically sterilized patients of childbearing potential must agree to use effective birth control from consent until about 6 months after last dose; vasectomized men must also use condoms.
Not Eligible

You will not qualify if you...

  • Known allergy or hypersensitivity to any component of ABSK131.
  • Prior treatment with PRMT5 or MAT2A inhibitor therapy.
  • Presence of another active primary malignancy.
  • Unable to swallow capsules or having malabsorption syndrome or significant gastrointestinal disease affecting function.
  • Prior toxicities from cancer therapies not resolved to Grade 60;1 severity except allowed exceptions.
  • Use of potent CYP3A inhibitors or inducers within 2 weeks before first dose; consumption of certain fruit products within 3 days before first dose.
  • Use of proton pump inhibitors within 7 days before first dose.
  • Imaging showing tumor invasion of large blood vessels or bleeding risk.
  • Current spinal cord compression, leptomeningeal disease, or symptomatic unstable brain metastases.
  • Impaired cardiac function or significant cardiac disease.
  • Known AIDS-related illness or positive HIV test.
  • Hepatitis infection.
  • Uncontrolled or refractory ascites, pleural or pericardial effusion requiring intervention within 2 weeks before first dose.
  • Confirmed or suspected interstitial lung disease or pneumonitis requiring steroids or oxygen.
  • Pregnant or nursing women.
  • Live vaccine within 4 weeks before first dose except inactivated vaccines.
  • History of allogenic tissue or solid organ transplant.
  • Psychiatric or substance abuse disorder interfering with study compliance.
  • Other significant comorbidities that could compromise safety or study compliance.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China, 201210

Actively Recruiting

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Research Team

Y

Ying Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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