A Phase I Study of SCC244 in Patients with Advanced MET Alterations Solid Tumors
- Conditions
- Advanced Solid Tumor
- Interventions
- Drug: Gumarontinib Tablets
- Registration Number
- NCT03457532
- Lead Sponsor
- Haihe Biopharma Co., Ltd.
- 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;
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 177
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose escalation study of Gumarontinib Gumarontinib Tablets To determine the maximum tolerated dose (MTD) of Gumarontinib
- Primary Outcome Measures
Name Time Method DLT(Dose limit toxity) 35 days To evaluate the DLT in patients with advanced solid tumor
MTD(Max tolerance does) 35 days To evaluate the MTD in patients with advanced solid tumor
BED(Biological effective dose) 35 days To evaluate the BED in patients with advanced solid tumor
objective response rate (ORR) 8 weeks To evaluate the ORR in patients with advanced solid tumor in Ib
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai East hospital
🇨🇳Shanghai, China