NCT05119933

A Phase 1/2, Study of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation

A Phase 1/2, Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, open-label, multicenter study designed to evaluate the maximum tolerated, safety, tolerability and PK of oral YY-15293 in patients with advanced solid tumors with a KRAS G12C mutation, to confirm the recommended phase 2 dose of YY-15293, and to obtain preliminary efficacy information in patients with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation.

Detailed description

The study will be conducted in the United States of America (USA) and China to provide safety, efficacy and PK data from these regions. A dose escalation part 1 will be conducted to determine the MTD, DLT's, and part 2 will confirm the safety/tolerability of the recommended Phase 2 dose (RP2D), of YL-15293 given once daily, in patients with advanced NSCLC to obtain preliminary efficacy information. PK samplings at Cycle 1, Day 1 and at steady-state conditions (Cycle 1, Day 28) will be performed. PD evaluations will occur at cycle 1 and cycle 2.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	YL-15293	After a screening period of approximately 28 days, eligible patients will receive oral YL-15293 once daily until documented disease progression, unacceptable AEs, intercurrent illness prevents further administrations of study treatment, investigator's decision to withdraw the patient, the patient withdraws consent, pregnancy of the patient, or for administrative reasons (see Section 7.1). 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 withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.

Timeline

• Start date: 2021-11-09
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2021-11-15
• Last updated: 2021-11-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study