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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbisko Therapeutics Co, Ltd

About this trial

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.

Eligibility criteria

Qualifiers

Participants should understand, sign, and date the written informed consent form prior to screening.

Male or female age 18 years or older

Participants with histologically confirmed locally-advanced or metastatic solid tumors harboring KRAS alteration

ECOG performance status 0 or 1

Disqualifiers

Known allergy or hypersensitivity to any component of the investigational product

Participants who were previously treated with any inhibitors targeting specific KRAS alleles, pan-KRAS inhibitors, pan- or multi-RAS inhibitors, or any other treatments directly targeting RAS.

Has a known additional malignancy that is progressing or has required active treatment

Has swallowing dysfunction or malabsorption syndrome

Trial design

Treatments tested in this trial

  • ABSK211

Treatment groups

247 Participants
are divided into 1 treatment group

Sponsors and collaborators