NCT07417189

A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )

A Phase I/II, Open-Label Study of ABSK141 to Assess Safety, Tolerability, Efficacy and Pharmacokinetics in Patients With KRAS G12D Mutant Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 401 (estimated)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human (FIH), exploratory, multicenter, open-label, phase I/II study of ABSK141 in patients with advanced solid tumors to to evaluate safety, tolerability, PK and optimize the dosage.

Detailed description

The study will start with a dose escalation of oral ABSK141 in patients with advanced solid tumors harboring KRAS G12D mutation to evaluate safety, tolerability, and PK. The expansion part will investigate oral ABSK141 at the recommended doses for expansion (RDEs) to evaluate safety and efficacy among selected tumor types harboring KRAS G12D mutation and optimize the dosage. The phase II study will further investigate oral ABSK141 at the recommended phase 2 doses (RP2Ds) to evaluate safety and efficacy among selected tumor types harboring KRAS G12D mutation.

Conditions

• Solid Tumors, Adult

Interventions

Type	Name	Description
DRUG	ABSK141-400mg	In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 400mg administration. Thereafter, patients will continuously receive ABSK141 400mg once daily (QD).
DRUG	ABSK141-Recommended Dose for Expansion (RDE)	In the expansion part# patients will orally receive ABSK141 at the recommended dose for expansion (RDE).patients will continuously receive ABSK141 Recommended Dose for Expansion (RDE) once daily (QD).
DRUG	ABSK141-800mg	In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 800mg administration. Thereafter, patients will continuously receive ABSK141 800mg once daily (QD).
DRUG	ABSK141-1200mg	In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 1200mg administration. Thereafter, patients will continuously receive ABSK141 1200mg once daily (QD).
DRUG	ABSK141-Recommended Phase 2 dose (RP2D)	Phase II #patients will orally receive ABSK141 at the Recommended Phase 2 Dose (RP2D).

Timeline

• Start date: 2026-03-02
• Primary completion: 2028-12-30
• Completion: 2029-07-30
• First posted: 2026-02-18
• Last updated: 2026-03-11

Locations

1 site across 1 country: China