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CFT8634 for Advanced Sarcoma

Phase 1 & 2
Waitlist Available
Research Sponsored by C4 Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 48 months
Awards & highlights

Summary

This trial is testing a new drug for people with cancer who have had other treatments that didn't work and can't have any other treatments that are known to help.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for CFT8634 aren't listed here as it’s a first-in-human study, common side effects from similar cancer treatments may include nausea, fatigue, liver problems like increased enzymes indicating inflammation or damage; blood disorders such as low counts leading to higher infection risk; digestive issues; potential heart rhythm changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and severity of AEs and serious adverse events (SAEs)
Frequency of dose interruptions and dose reductions
Incidence of dose limiting toxicities (DLTs)
+2 more
Secondary outcome measures
Asses dose proportionality assessment
Assess the pharmacodynamics by percent reduction from baseline of target protein
Duration of Response (DOR)
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2 - Arm B: CFT8634Experimental Treatment1 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: CFT8634Experimental Treatment1 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: CFT8634Experimental Treatment1 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: CFT8634Experimental Treatment1 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Synovial Sarcoma treatments typically include chemotherapy, radiation, and targeted therapies. Chemotherapy kills rapidly dividing cells, including cancer cells, while radiation therapy damages the DNA of cancer cells, leading to their death. Targeted therapies, such as tyrosine kinase inhibitors, focus on specific molecular abnormalities in cancer cells, sparing normal cells. The trial CFT8634 is investigating a new treatment, likely with a novel mechanism of action, which could provide more effective and less toxic options. Understanding these mechanisms helps in selecting the best treatment strategy, improving outcomes and minimizing side effects for patients.
Precision Oncology Framework for Investigation of Exercise As Treatment for Cancer.Targeted therapies for soft-tissue sarcomas.

Find a Location

Who is running the clinical trial?

C4 Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
364 Total Patients Enrolled

Media Library

CFT8634 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05355753 — Phase 1 & 2
Synovial Sarcoma Research Study Groups: Dose Escalation Phase 1/Part1: CFT8634, Dose Escalation Phase 1/Part 2: CFT8634, Phase 2 - Arm B: CFT8634, Phase 2 - Arm A: CFT8634
Synovial Sarcoma Clinical Trial 2023: CFT8634 Highlights & Side Effects. Trial Name: NCT05355753 — Phase 1 & 2
CFT8634 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05355753 — Phase 1 & 2
~15 spots leftby Jul 2025
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