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Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors
Sponsor: Cosmo Technologies Ltd
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.
Official title: Open Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 With Dose Expansion Phase, in Subjects With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2022-06-14
Completion Date
2026-06-01
Last Updated
2024-02-07
Healthy Volunteers
No
Interventions
CB-03-10
CB-03-10, 100 mg capsule for oral use
Locations (6)
University of California Irvine Health Chao Family Comprehensive Cancer Center
California City, California, United States
University of Colorado Cancer Center
Colorado Springs, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Barbara Ann Karmanos Cancer Institute
Michigan Center, Michigan, United States
Gabrail Cancer Center
Ohio City, Ohio, United States
Tranquil Clinical Research
Texas City, Texas, United States