This is a phase II, Single-arm,Open-label Study evaluating the safety and efficacy of CT053PTSA in Advanced Solid Tumors With MET Exon 14 Skipping Mutations
This study is being carried out in two parts, part 1 and part 2. Part 1:Observation phase of dose tolerance: Objective To observe the tolerability and safety of 60 mg CT053PTSA in advanced NSCLC patients with Metex14 skipping mutation, and to determine the recommended dose (RED) in the dose expansion phase。 Part 2: This is the expansion part and will continue to evaluate the safety and efficacy of CT053PTSA at the dose of RED in advanced NSCLC patients with Metex14 skipping mutation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
CT053PTSA will be administered orally once a day
Recommended Extended Dose
Recommended dose for expansion phase
Time frame: Cycle 1Day 1 to Cycle 1 Day 28±3
Objective response rate
Objective response rate (ORR) is defined as the percentage of the participants in the analysis population who have a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 by investigators
Time frame: up to 4 years
Duration of response
Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first. Includes participants with complete response or partial response
Time frame: up to 4 years
Progression-free survival
defined as the time from date of randomization until the earliest date of disease progression, as determined by independent central review of objective radiographic disease assessments per RECIST 1.1, or death from any cause, whichever comes first.
Time frame: up to 4 years
Overall survival
Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.
Time frame: up to 4 years
Disease Control Rate
proportion of patients with best overall response of CR, PR or stable disease (SD)
Time frame: up to 4 years
Adverse events related to CT053
description, timing, grade (Common Terminology Criteria for Adverse Events Version 5.0 \[CTCAE v5.0\]), severity, seriousness, and relatedness
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Time frame: up to 4 years