An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characters, and Preliminary Efficacy of SCC244 in Patients with Advanced MET Alterations Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Gumarontinib Tablets
- Conditions
- Advanced Solid Tumor
- Sponsor
- Haihe Biopharma Co., Ltd.
- Enrollment
- 177
- Locations
- 1
- Primary Endpoint
- DLT(Dose limit toxity)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a Phase 1a/1b multi-center and open label study to evaluate the safety, tolorability, pharmacokinetics and priliminary efficacy of SCC244 in advanced solid tumors patients with c-MET alteration
Detailed Description
This is a phase I study, its purpose to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD)/ biologically effective dose (BED) and the recommended phase II dose (RP2D) of SCC244 monotherapy in patients with advanced MET alterations solid tumors;
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose escalation study of Gumarontinib
To determine the maximum tolerated dose (MTD) of Gumarontinib
Intervention: Gumarontinib Tablets
Outcomes
Primary Outcomes
DLT(Dose limit toxity)
Time Frame: 35 days
To evaluate the DLT in patients with advanced solid tumor
MTD(Max tolerance does)
Time Frame: 35 days
To evaluate the MTD in patients with advanced solid tumor
BED(Biological effective dose)
Time Frame: 35 days
To evaluate the BED in patients with advanced solid tumor
objective response rate (ORR)
Time Frame: 8 weeks
To evaluate the ORR in patients with advanced solid tumor in Ib