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RECRUITING
NCT03863145
EARLY_PHASE1

Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors

Sponsor: Cosmo Technologies Ltd

View on ClinicalTrials.gov

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

DRUG

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