Synovial SarcomaPhase 1NCT05355753
A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors
A Phase 1 study testing CFT8634 in people with Synovial Sarcoma and Soft Tissue Sarcoma, run by C4 Therapeutics, Inc. at 12 sites in United States.
Trial summary
This is an open-label, non-randomized, first-in-human Phase 1/2 study designed to evaluate the safety and tolerability of CFT8634 in subjects with synovial sarcoma and SMARCB1-null tumors who: have received prior systemic therapy; have relapsed/refractory tumors; have unresectable or metastatic disease; and are not… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Synovial Sarcoma, Soft Tissue Sarcoma
- What is being tested?
- CFT8634
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 12 sitesUnited States
- Study dates
- 25 Mar 2022to 19 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject (and legal guardian where applicable) is (are) willing and able to provide signed informed consent (or assent, where applicable) and can follow protocol requirements
- 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
- Phase 1: subject must have received ≥1 prior line of systemic anticancer therapy considered to be Standard of Care per the Investigator's judgment, in the metastatic or unresectable setting b. Phase 2: i. 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 ii. Arm B: subject must have received ≥1 prior line of systemic anticancer therapy considered to be Standard of Care per the Investigator's judgment, in the metastatic or unresectable setting
- Subject must be:
- ≥18 years of age (no minimum weight),
- ≥16 and <18 years old and weighs ≥50 kg,
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- ≥12 and <16 years of age and weighs ≥40kg,
- or ≥16 and <18 years of age and weighs ≥40kg and <50kg
- Subject must be able to safely swallow capsules
- Subject must have measurable disease as defined by RECIST v1.1
- Subject must have Eastern Cooperative Oncology Group performance status ≤2 or Lansky performance scale (LK scale) ≥ 60
- Subject must have adequate organ function, defined as:
- Bone marrow function: absolute neutrophil count ≥1.0 x 109/L independent of growth factor support for ≤7 days prior to first dose of study drug for granulocyte colony-stimulating factor and ≤14 days prior to first dose of study drug for peg-filgrastim; hemoglobin ≥8 g/dL independent of transfusion support for ≤7 days prior to first dose of study drug; platelet count ≥75 x 109 /L independent of transfusion support for ≤3 days prior to first dose of study drug
- Coagulation: Prothrombin time (PT)/international normalized ratio (INR) <1.5x the upper limit of normal (ULN) and activated partial thromboplastin time (aPTT) <1.5x ULN (unless the subject is receiving anticoagulant therapy and INR and partial PT/aPTT are within therapeutic range of intended use of anticoagulants)
- Liver function: total bilirubin ≤1.5x ULN (≤3.0x ULN for subjects with Gilbert's syndrome), aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0x ULN; except for subjects who have tumor infiltration of the liver, where ALT and AST ≤5x ULN
- Renal function: must have a creatinine clearance ≥60 mL/min (via Cockcroft-Gault equation, institutional standard, or measured)
- Cardiac function: baseline corrected QT interval using Fredericia's formula ≤470 ms (adolescents 12-17 years of age: ≤450 ms) and a left ventricular ejection fraction ≥50% evaluated via echocardiogram or multi-gated acquisition (MUGA) scan
- Availability of archival tumor tissue sample or newly obtained core/excisional biopsy of a tumor not previously irradiated
- A female subject may be eligible to participate if she is not pregnant or planning a pregnancy, not breastfeeding, and following protocol mediated guidance to avoid pregnancy
- A male subject must have had a prior vasectomy and agree to use a condom during the treatment period and for at least 90 days after the last dose of study treatment
- A male subject must refrain from donating sperm while taking CFT8634 and for 90 days post-last dose
- A female subject must refrain from donating ova while taking CFT8634 and for 180 days after discontinuation
- All subjects must refrain from donating blood and blood products while receiving study drug and for 30 days post-last dose
Who cannot join
- Subject has had major surgery within 21 days prior to the planned first dose of CFT8634
- Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 21 days prior to first dose of CFT8634
- 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
- Prior treatment with BRD9 degrader
- Subject has central nervous system (CNS) involvement (primary tumor or metastatic disease), except in the following circumstances:
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- Subjects with previously treated brain metastases may be permitted to participate provided they are stable (without evidence of progression by imaging 14 days prior to the first dose of study drug and any neurologic symptoms have stabilized), have no evidence of new or enlarging brain metastases, and if they are taking corticosteroids, they are on stable or tapering doses for at least 7 days prior to first dose of study drug. Antiseizure therapy is permitted provided the medication is not otherwise excluded and seizures have been controlled for at least 28 days since the last antiseizure medication adjustment
- Subjects with asymptomatic brain metastases found on Screening magnetic resonance imaging (MRI) may be permitted to be entered into the study without prior radiation therapy to the brain if they do not require immediate surgical or radiation therapy in the opinion of the treating investigator and in the opinion of a radiation therapy or neurosurgical consultant
- Subject has any evidence of a CNS bleed including intra-tumoral hemorrhage
- Subject has known bleeding diathesis
- Subject has impaired cardiac function or clinically significant cardiac disease (i.e. uncontrolled heart disease/hypertension, clinically significant arrythmias, unstable angina/myocardia infarction/stroke within 180 days prior to screening)
- Subject with presence of inflammatory vascular disease or microangiopathy (eg, thrombotic microangiopathies, hemolytic uremic syndrome [HUS], atypical HUS)
- Subject with known malignancy, other than study indication, that is progressing or has required treatment within the past 3 years
- Subject with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (i.e. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded
- Subject has received live, attenuated vaccine within 28 days prior to first dose administration
- Subject with known history of human immunodeficiency virus (HIV) infection
- Subject had a venous thrombosis within 14 days prior to first dose of study drug
- Subject with gastrointestinal absorption issues (e.g., malabsorption syndrome or other illness that could affect oral absorption).
- Concurrent administration of strong cytochrome P450 (CYP) 3A4 inhibitors and inducers, and multidrug resistance mutation 1 (MDR1) inhibitors.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Colorado - Aurora Cancer Center
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
City of Hope
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Columbia University
New York, New York, 10027
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Sarcoma Oncology Research Center
Santa Monica, California, 90403
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1/2 Open-Label, Multicenter Study to Characterize the Safety and Tolerability of CFT8634 in Subjects With Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors
This is an open-label, non-randomized, first-in-human Phase 1/2 study designed to evaluate the safety and tolerability of CFT8634 in subjects with synovial sarcoma and SMARCB1-null tumors who: have received prior systemic therapy; have relapsed/refractory tumors; have unresectable or metastatic disease; and are not candidates for available therapies known to confer clinical benefit. The study will characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of CFT8634.
Read the detailed description
The study was intended to be Phase 1/2 trial but did not advance to Phase 2.
- Conditions
- Synovial Sarcoma, Soft Tissue Sarcoma
- Being tested
- CFT8634
- Keywords
- Synovial Sarcoma, SMARB1-Null Tumors, CFT8634, Soft Tissue Sarcoma, Myoepithelial Carcinoma, Extraskeletal Myxoid Chondrosarcoma, Renal Medullary Carcinoma, Chordoma, Epithelioid Sarcoma
- Medical subject headings
- Sarcoma, Synovial, Sarcoma, Chondrosarcoma, Extraskeletal Myxoid, Chordoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFT8634Drug
Oral dose of CFT8634
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase 1/Part1: CFT8634 | Experimental | 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 Receives: Drug: CFT8634 |
| Dose Escalation Phase 1/Part 2: CFT8634 | Experimental | 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 Receives: Drug: CFT8634 |
| Phase 2 - Arm A: CFT8634 | Experimental | Approximately 30 subjects with locally advanced or metastatic synovial sarcoma at the recommended phase 2 dose (RP2D) having received 1-2 prior anticancer therapies Receives: Drug: CFT8634 |
| Phase 2 - Arm B: CFT8634 | Experimental | Approximately 20 subjects with locally advanced or metastatic SMARCB1-null tumors at the RP2D having received ≥1 prior anticancer therapy Receives: Drug: CFT8634 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of AEs and serious adverse events (SAEs)
Phase 1 and Phase 2
Measured: From screening until at least 30 days after completion of study treatment
Number of subjects with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
Phase 1 and Phase 2
Measured: From screening until at least 30 days after completion of study treatment
Frequency of dose interruptions and dose reductions
Phase 1 and Phase 2
Measured: From first dose until end of treatment
Incidence of dose limiting toxicities (DLTs)
Phase 1 only
Measured: From first dose until 28 days after first dose
Overall Response Rate (ORR)
Phase 2 only according to RECIST v1.1 criteria
Measured: Up to approximately 24 months
Secondary outcomes (8)
Plasma concentration of CFT8634 to characterize the pharmacokinetics (PK) parameters of CFT8634
Plasma concentration of CFT8634 at the scheduled timepoints
Measured: At multiple time points up to approximately 24 weeks
Asses dose proportionality assessment
Dose proportionately assessment at the scheduled timepoints
Measured: At multiple time points up to approximately 24 weeks
Assess the pharmacodynamics by percent reduction from baseline of target protein
Tumor BRD9 degradation at scheduled timepoints
Measured: At multiple time points up to approximately 24 weeks
ORR
Phase 1 only according to RECIST v1.1 criteria
Measured: Up to approximately 24 months
Duration of Response (DOR)
DOR defined as time from first assessment of PR or CR to follow-on first assessment of progressive disease (PD)
Measured: Up to approximately 24 months
Progression Free Survival (PFS)
PFS defined as the time from first treatment received until PD is assessed
Measured: Up to approximately 24 months
Overall Survival (OS)
OS is defined as the time from first dose of study treatment to the date of death, irrespective of the cause of death. (Phase 2 only)
Measured: Up to approximately 48 months
Time to next treatment
Interval from the date of initiation of a treatment to the date of commencement of the next line of therapy
Measured: Up to approximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start25 Mar 2022
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Why it stopped: High levels of BRD9 degradation did not result in sufficient efficacy in heavily pre-treated synovial sarcoma and SMARCB1-null solid tumor patients treated with CFT8634 as a single agent.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Synovial SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- C4 Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355753
- Sponsor's protocol ID
- CFT8634-1101
- Status last verified
- Dec 2024
- First submitted
- 23 Apr 2022
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-Label, Multicenter Study to Characterize the Safety and Tolerability of CFT8634 in Subjects With Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors
- ClinicalTrials.gov ID
- NCT05355753
- Acronym / sponsor ID
- CFT8634-1101
- Conditions
- Synovial Sarcoma, Soft Tissue Sarcoma
- Keywords
- Synovial Sarcoma, SMARB1-Null Tumors, CFT8634, Soft Tissue Sarcoma, Myoepithelial Carcinoma, Extraskeletal Myxoid Chondrosarcoma, Renal Medullary Carcinoma, Chordoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High levels of BRD9 degradation did not result in sufficient efficacy in heavily pre-treated synovial sarcoma and SMARCB1-null solid tumor patients treated with CFT8634 as a single agent.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- C4 Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, non-randomized, first-in-human Phase 1/2 study designed to evaluate the safety and tolerability of CFT8634 in subjects with synovial sarcoma and SMARCB1-null tumors who: have received prior systemic therapy; have relapsed/refractory tumors; have unresectable or metastatic disease; and are not candidates for available therapies known to confer clinical benefit. The study will characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of CFT8634.
Detailed description
The study was intended to be Phase 1/2 trial but did not advance to Phase 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase 1/Part1: CFT8634 | Experimental | Drug: CFT8634Up 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 |
| Dose Escalation Phase 1/Part 2: CFT8634 | Experimental | Drug: CFT8634Up 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 |
| Phase 2 - Arm A: CFT8634 | Experimental | Drug: CFT8634Approximately 30 subjects with locally advanced or metastatic synovial sarcoma at the recommended phase 2 dose (RP2D) having received 1-2 prior anticancer therapies |
| Phase 2 - Arm B: CFT8634 | Experimental | Drug: CFT8634Approximately 20 subjects with locally advanced or metastatic SMARCB1-null tumors at the RP2D having received ≥1 prior anticancer therapy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Subject (and legal guardian where applicable) is (are) willing and able to provide signed informed consent (or assent, where applicable) and can follow protocol requirements
- 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
- Subject must be:
- Subject must be able to safely swallow capsules
- Subject must have measurable disease as defined by RECIST v1.1
Key exclusion criteria (19 listed)
- Subject has had major surgery within 21 days prior to the planned first dose of CFT8634
- 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
- Prior treatment with BRD9 degrader
- Subject has central nervous system (CNS) involvement (primary tumor or metastatic disease), except in the following circumstances:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CFT8634Oral dose of CFT8634 | Drug | Dose Escalation Phase 1/Part 2: CFT8634, Dose Escalation Phase 1/Part1: CFT8634, Phase 2 - Arm A: CFT8634, Phase 2 - Arm B: CFT8634 |
Primary outcome
Frequency and severity of AEs and serious adverse events (SAEs)
Time frame: From screening until at least 30 days after completion of study treatment
Phase 1 and Phase 2
Number of subjects with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
Time frame: From screening until at least 30 days after completion of study treatment
Phase 1 and Phase 2
Frequency of dose interruptions and dose reductions
Time frame: From first dose until end of treatment
Phase 1 and Phase 2
Incidence of dose limiting toxicities (DLTs)
Time frame: From first dose until 28 days after first dose
Phase 1 only
Overall Response Rate (ORR)
Time frame: Up to approximately 24 months
Phase 2 only according to RECIST v1.1 criteria
8 secondary outcomes
Plasma concentration of CFT8634 to characterize the pharmacokinetics (PK) parameters of CFT8634
Time frame: At multiple time points up to approximately 24 weeks
Asses dose proportionality assessment
Time frame: At multiple time points up to approximately 24 weeks
Assess the pharmacodynamics by percent reduction from baseline of target protein
Time frame: At multiple time points up to approximately 24 weeks
ORR
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Progression Free Survival (PFS)
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 48 months
Time to next treatment
Time frame: Up to approximately 8 months
Results and safety
The study was stopped early (reason given: High levels of BRD9 degradation did not result in sufficient efficacy in heavily pre-treated synovial sarcoma and SMARCB1-null solid tumor patients treated with CFT8634 as a single agent.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CFT8634 in people with Synovial Sarcoma and Soft Tissue Sarcoma, run by C4 Therapeutics, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: High levels of BRD9 degradation did not result in sufficient efficacy in heavily pre-treated synovial sarcoma and SMARCB1-null solid tumor patients treated with CFT8634 as a single agent.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of AEs and serious adverse events (SAEs) (time frame: From screening until at least 30 days after completion of study treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.