NCT06078800

A Study of YL-17231 in Patients With Advanced Solid Tumors

Phase I Clinical Study on the Safety, Tolerance, Pharmacokinetics and Efficacy of Pan-KRAS Inhibitor YL-17231 in Patients With Advanced Solid Tumors With KRAS Mutation

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of oral YL-17231 in patients with advanced solid tumors with KRAS mutation, so as to confirm the recommended phase 2 dose of YL-17231 and obtain the preliminary efficacy information of patients with advanced solid tumors with KRAS mutation.

Detailed description

The study will be conducted in China to provide safety, efficacy and PK data. A dose escalation part 1 will be conducted to determine the MTD, DLTs, and part 2 will confirm the safety/tolerability of the recommended Phase 2 dose (RP2D), of YL-17231 given twice daily, in patients with advanced solid tumors to obtain preliminary efficacy information. PK samplings at single dose stage Day 1 and at steady-state conditions (Cycle 1, Day 14) will be performed.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	YL-17231	After a screening period of approximately 14 days, eligible patients will receive oral YL-17231 once or twice daily until documented disease progression, unacceptable AEs, intercurrent illness preventing further administrations of study treatment, investigator's decision to withdrawal, the patient's consent of withdrawal, pregnancy, or for administrative reasons. Following the end of treatment, patients will continue to be followed for safety for 30 days. Patients who permanently discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient's consent of withdrawal, lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.

Timeline

• Start date: 2023-09-28
• Primary completion: 2025-03-01
• Completion: 2025-12-01
• First posted: 2023-10-12
• Last updated: 2023-10-12

Locations

1 site across 1 country: China