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RECRUITING
NCT07718165
PHASE1

A Phase I Study of ABSK211 in Participants With Advanced Solid Tumors With KRAS Alteration

Sponsor: Abbisko Therapeutics Co, Ltd

View on ClinicalTrials.gov

Summary

This is a first-in-human (FIH), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.

Official title: A Phase I, Open-Label Study of ABSK211 to Assess Safety, Tolerability, Efficacy and Pharmacokinetics in Participants With Advanced Solid Tumors With KRAS Alteration

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

247

Start Date

2026-08-28

Completion Date

2030-06-30

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

ABSK211

During the escalation part ,all participants will firstly receive a single dose of ABSK211 as a run-in period to access the safety and PK of ABSK211. Then, participants will continuously receive ABSK211 once daily (QD), with each treatment cycle of 21 days; In the expansion part,participants will orally receive ABSK211 at the recommended dose for expansion (RDE).

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China