Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors
- Conditions
- Advanced Refractory Solid TumorsSubjects Considered Likely to Respond to CB-03-10
- Interventions
- Registration Number
- NCT03863145
- Lead Sponsor
- Cosmo Technologies Ltd
- Brief Summary
Subjects will undergo baseline evaluation and an assessment of extent of disease.
Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints for all subjects.
Subjects in Part 2 (Dose Expansion) of the study will receive CB-03-10 at the RP2D determined in the Part 1 of the study. The indications included in each group will be determined at the completion of Part 1 of the study by Safety Review Committee (SRC).
Subjects will be evaluated weekly initially (for 2 cycles in Part 1 and for 1 cycle in Part 2) and every 2 weeks thereafter. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation.
- Detailed Description
Subjects will undergo baseline evaluation and an assessment of extent of disease.
Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints for all subjects.
Subjects in Part 2 (Dose Expansion) of the study will receive CB-03-10 at the RP2D determined in the Part 1 of the study. The indications included in each group will be determined at the completion of Part 1 of the study by Safety Review Committee (SRC).
Subjects will be evaluated weekly initially (for 2 cycles in Part 1 and for 1 cycle in Part 2) and every 2 weeks thereafter. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 1 CB-03-10 Part 1 (Dose Escalation): 100 mg daily.
- Primary Outcome Measures
Name Time Method Determine the maximum tolerated dose 29 days Determine the maximum tolerated dose (MTD) of CB-03-10 in subjects with advanced solid tumors
Determine the dose-limiting toxicity 28 days Determine the dose-limiting toxicity (DLT) of CB-03-10 in subjects with advanced solid tumors
- Secondary Outcome Measures
Name Time Method Determine a recommended Phase 2 dose (RP2D) of CB-03-10 28 days Determine a recommended Phase 2 dose (RP2D) of CB-03-10
Trial Locations
- Locations (6)
Gabrail Cancer Center
🇺🇸Ohio City, Ohio, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Michigan Center, Michigan, United States
University of Colorado Cancer Center
🇺🇸Colorado Springs, Colorado, United States
University of California Irvine Health Chao Family Comprehensive Cancer Center
🇺🇸California City, California, United States
Tranquil Clinical Research
🇺🇸Texas City, Texas, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States