NCT07288957

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors (Phase 1)

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-07-22
• Primary completion: 2028-12-30
• Completion: 2029-07-30
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study