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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
Subject has histologically or cytologically confirmed synovial sarcoma or SMARCB1-null sold tumor that is relapsed/refractory, and unresectable or metastatic; the subject must not be a candidate for available therapies that are known to confer clinical benefit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 48 months
Awards & highlights
No Placebo-Only Group

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a type of cancer called synovial sarcoma or SMARCB1-null solid tumor that has come back, is not responding to treatment, and has spread to other parts of your body. You cannot receive any other treatments that have been proven to help.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

C4 Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
260 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widely is this clinical experiment being conducted within the state?

"Currently, 10 medical centres are recruiting participants for this trial. These locations span Aurora, Duarte and New york City; other nearby cities also offer sites to enrol in the study. To reduce travel needs, it is wise to select a facility close by your home or work location."

Answered by AI

Are researchers currently seeking participants for this trial?

"Affirmative. According to clinicaltrials.gov, this experiment was initially advertised on March 25th 2022 and recently modified on September 26th of the same year; it currently requires 110 participants spread across 10 different sites."

Answered by AI

How many participants are actively engaged in this research endeavor?

"C4 Therapeutics, Inc. is responsible for facilitating the clinical trial and has determined that 110 qualified participants are needed to proceed with data collection. The study will be conducted in two locations: University of Colorado - Aurora Cancer Center in Aurora,Colorado and City of Hope in Duarte, California."

Answered by AI

What results is this trial designed to produce?

"This clinical trial intends to evaluate the frequency and intensity of adverse events (AEs) and serious adverses events (SAEs) over a period extending from enrolment until at least 30 days after completion of treatment. Secondary endpoints include assessing the percent reduction in tumour BRD9 degradation, characterizing CFT8634's pharmacokinetics parameters through plasma concentration monitoring, and measuring DOR - defined as time from first assessment of PR or CR to follow-on first assessment of progressive disease (PD)."

Answered by AI

Who else is applying?

What site did they apply to?
City of Hope
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
~18 spots leftby Feb 2025