CB-03-10 for Advanced Cancers
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you should not have had anticancer therapy within 28 days before starting the study. It's best to discuss your specific medications with the trial team.
Eligibility Criteria
Adults over 18 with advanced solid tumors that can't be treated with standard therapy may join. They must have a performance status indicating they're still fairly active, proper organ function, and for women of childbearing age, a negative pregnancy test and use of birth control. People are excluded if they have autoimmune diseases, serious heart issues, uncontrolled high blood pressure, recent major surgery or radiation, recent other cancer treatments, hepatitis B/C or HIV infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Subjects 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.
Dose Expansion
Subjects receive CB-03-10 at the RP2D determined in Part 1 of the study. Indications included in each group will be determined by the Safety Review Committee.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response will be re-evaluated at least 4 weeks later for confirmation.
Treatment Details
Interventions
- CB-03-10
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cosmo Technologies Ltd
Lead Sponsor