CFT8634 for Synovial Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MD Anderson Cancer Center, Houston, TX
Synovial Sarcoma+3 More
CFT8634 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors with unresectable or metastatic disease, following at least 1 prior line of standard-of-care systemic therapy and must not be candidates for therapies available that are known to confer clinical benefit.

Eligible Conditions

  • Synovial Sarcoma
  • Soft Tissue Sarcoma (STS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Synovial Sarcoma

Study Objectives

6 Primary · 7 Secondary · Reporting Duration: Up to approximately 48 months

Week 6
Assess the pharmacodynamics by percent reduction from baseline of target protein
Plasma concentration of CFT8634 to characterize the pharmacokinetics (PK) parameters of CFT8634
Day 30
Frequency and severity of AEs and serious adverse events (SAEs)
Frequency of dose interruptions and dose reductions
Incidence of dose limiting toxicities (DLTs)
Number of participants with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
Number of participants with changes from baseline in ECG parameters
Month 30
Duration of Response (DOR)
ORR
Overall Response Rate (ORR)
Month 40
Progression Free Survival (PFS)
Month 48
Overall Survival (OS)
Time to next treatment

Trial Safety

Safety Progress

1 of 3

Other trials for Synovial Sarcoma

Trial Design

3 Treatment Groups

Phase 2 - Arm B: CFT8634
1 of 3
Phase 1: CFT8634
1 of 3
Phase 2 - Arm A: CFT8634
1 of 3
Experimental Treatment

110 Total Participants · 3 Treatment Groups

Primary Treatment: CFT8634 · No Placebo Group · Phase 1 & 2

Phase 2 - Arm B: CFT8634
Drug
Experimental Group · 1 Intervention: CFT8634 · Intervention Types: Drug
Phase 1: CFT8634
Drug
Experimental Group · 1 Intervention: CFT8634 · Intervention Types: Drug
Phase 2 - Arm A: CFT8634
Drug
Experimental Group · 1 Intervention: CFT8634 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 48 months
Closest Location: MD Anderson Cancer Center · Houston, TX
Photo of MD Anderson Cancer Center 1Photo of MD Anderson Cancer Center 2Photo of MD Anderson Cancer Center 3
2004First Recorded Clinical Trial
6 TrialsResearching Synovial Sarcoma
520 CompletedClinical Trials

Who is running the clinical trial?

C4 Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
158 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have synovial sarcoma.\n
You have Eastern Cooperative Oncology Group performance status ≤2.
Coagulation: Prothrombin time (PT)/international normalized ratio (INR) <1.
You are willing and able to provide informed consent (or assent when applicable) and can follow protocol requirements.
You have a tumor that is positive for SMARCB1 protein.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.