CB-03-10 for Advanced Cancers

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Cosmo Technologies Ltd

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: CNS metastases, Second cancer, Autoimmune, Cardiac, others

No Placebo Group

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

My cancer has returned or didn’t respond to treatment and can't be treated with standard methods.

My cancer has returned or didn’t respond to treatment and is now advanced or has spread.

For Part 1 (Dose Escalation): Measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria

+6 more

Exclusion Criteria

My cancer has spread to my brain or spinal cord.

Known infection with hepatitis B or C virus

I have HIV with a CD4+ T-cell count below 350.

+9 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

8 weeks

Weekly visits for 2 cycles, then every 2 weeks

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.

8 weeks

Weekly visits for 1 cycle, then every 2 weeks

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.

Long-term

Participant Groups

The trial is testing different doses of an oral drug called CB-03-10 in two parts: first to find the highest dose patients can take without severe side effects (MTD) and then to see how well it works at that dose (RP2D). Patients will be monitored regularly for their body's response to the drug and any changes in their tumors.

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

Part 1 (Dose Escalation): 100 mg daily.