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RECRUITING
NCT07288957
PHASE1

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2025-07-22

Completion Date

2029-07-30

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DRUG

ABSK131

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)

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China