RecruitingPhase 1NCT07288957

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

Sponsor

Abbisko Therapeutics Co, Ltd

Enrollment

266 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

Conditions

Solid Tumors (Phase 1)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ABSK131 for people with solid tumors (phase 1). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABSK131

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)