CFT8634 for Advanced Sarcoma

Recruiting at12 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: C4 Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called CFT8634 to see if it is safe and effective for patients with specific types of cancer who have no other treatment options. Researchers aim to find out if the drug can help reduce or control tumor growth.

Research Team

Eligibility Criteria

This trial is for adults and adolescents with advanced or metastatic synovial sarcoma or SMARCB1-null tumors who have tried other treatments without success. They must be able to swallow capsules, have adequate organ function, and not be pregnant or planning pregnancy. Participants need measurable disease per RECIST v1.1 criteria and can't join if they've had certain recent surgeries, therapies, CNS involvement that's unstable, significant cardiac issues, HIV infection, or are taking drugs affecting CFT8634 metabolism.

Inclusion Criteria

Phase 2: Arm A: subject must have received only 1-2 prior lines of systemic anticancer therapy considered to be Standard of Care per the Investigator's judgment, in the metastatic or unresectable setting

A male subject must refrain from donating sperm while taking CFT8634 and for 90 days post-last dose

All subjects must refrain from donating blood and blood products while receiving study drug and for 30 days post-last dose

Exclusion Criteria

Subject has received standard of care or investigational systemic anti-neoplastic therapy within 14 days or 5 half-lives, whichever is shorter, prior to the planned first dose of CFT8634

Subject has received radiation therapy within 14 days prior to the planned first dose of CFT8634

You have taken medication called BRD9 degrader before.

Treatment Details

Interventions

• CFT8634 (Other)

Trial Overview The study tests the safety and tolerability of a new drug called CFT8634 in patients with specific types of cancer that disrupt the SMARCB1 gene. It's an early-phase trial (Phase 1/2), meaning it's one of the first times this drug is being given to humans to see how safe it is and how well it works against these cancers.

Participant Groups

Group I: Phase 2 - Arm B: CFT8634 Experimental Treatment 1 Intervention

Approximately 20 subjects with locally advanced or metastatic SMARCB1-null tumors at the RP2D having received ≥1 prior anticancer therapy

Group II: Phase 2 - Arm A: CFT8634 Experimental Treatment 1 Intervention

Approximately 30 subjects with locally advanced or metastatic synovial sarcoma at the recommended phase 2 dose (RP2D) having received 1-2 prior anticancer therapies

Group III: Dose Escalation Phase 1/Part1: CFT8634 Experimental Treatment 1 Intervention

Up to approximately 40 subjects ≥18 years of age or between ≥16 and \<18 years of age and weighing ≥50 kg with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors, having received ≥ 1 prior anticancer therapy

Group IV: Dose Escalation Phase 1/Part 2: CFT8634 Experimental Treatment 1 Intervention

Up to approximately 6-12 subjects ≥12 and \<16 years of age and weighing ≥40 kg or ≥16 and \<18 years of age and weighing ≥40 kg and \<50 kg with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors

Who Is Running the Clinical Trial?

C4 Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

480+