Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors
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
Cosmo Technologies Ltd
90 participants
Jun 14, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Signed informed consent For Part 1 (Dose Escalation): Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor, not amenable to standard therapy For Part 2 (Dose Expansion): Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor limited to a specific tumor subtype as determined by the SRC Age >18 years Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 For Part 1 (Dose Escalation): Measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria For Part 2 (Dose Expansion): Measurable disease as per RECIST v1.1 criteria. Adequate renal, hepatic and bone marrow function as defined by Screening labs Negative pregnancy test for females of childbearing potential at the Screening Visit and use of appropriate method of birth control.
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Interventions
CB-03-10, 100 mg capsule for oral use
Locations(6)
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NCT03863145