Clinical trialPhase 1 / Phase 2Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 2 March 2026
- Expected end
- 30 July 2029
- Enrollment
- 401 participants
- Sites
- 1
- Primary outcomes
- Incidence of DLTs; Incidence and severity of AEs; Incidence and severity of SAEs
- Sponsor
- Industry
- Results posted
- No
- Last update
- 11 March 2026
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.