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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
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.
Innovative Clinical Research Institute
Whittier, California, United States
NOT_YET_RECRUITINGThe Tisch Cancer Institute Mount Sinai Health System Icahn School of Medicine at Mount Sinai
New York, New York, United States
NOT_YET_RECRUITINGOncology Consultants
Houston, Texas, United States
RECRUITINGThe overall response rate (ORR)
The overall response rate (ORR) will be estimated based on the proportion of evaluable patients whose overall response (ORR) during study treatment is CR or PR. Disease response will be assessed by the investigator using RECIST v1.1.
Time frame: Throughout the study for approximately 2 years
Progression free survival, PFS
PFS, defined as the time from the first dose of study treatment to first
Time frame: Throughout the study for approximately 2 years
Overall survival, OS
The time from randomization to death for any reason
Time frame: Throughout the study for approximately 2 years
Disease control rate, DCR
The percentage of cases with remission (PR+CR) and stable lesions (SD) after treatment
Time frame: Throughout the study for approximately 2 years
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