What side effects are associated with this type of intervention?

Common treatments for synovial sarcoma, such as chemotherapy (e.g., doxorubicin, ifosfamide) and targeted therapies (e.g., pazopanib), are associated with side effects including nausea, vomiting, hair loss, fatigue, increased infection risk, hypertension, liver toxicity, and hand-foot syndrome. Investigational agents like those in the CFT8634 trial may have unique side effects that are still being studied but could include similar toxicities.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of soft tissue sarcomas, including Synovial Sarcoma. Pazopanib, a tyrosine kinase inhibitor, is one such drug that has shown efficacy in treating advanced soft tissue sarcomas. Additionally, drugs like eribulin and trabectedin have been approved for liposarcoma and leiomyosarcoma, which are related types of soft tissue sarcomas. These treatments generally target cellular pathways involved in tumor growth and proliferation. While specific information on drugs with mechanisms similar to CFT8634 is not detailed, these examples provide a broad overview of the types of treatments available for Synovial Sarcoma.

What other types of research exist?

Promising novel alternatives to CFT8634 for Synovial Sarcoma patients include Pazopanib, which is a tyrosine kinase inhibitor approved for advanced soft tissue sarcomas, and Eribulin, which has shown activity in various subtypes of soft tissue sarcoma. Additionally, ongoing research into targeted therapies and immunotherapies may provide new options in the near future.

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CFT8634 for Advanced Sarcoma

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 48 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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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.