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Metastatic Myxoid LiposarcomaPhase 2NCT07686367

Testing the Anti-Cancer Drug, Brenetafusp (IMCF106C), in Rare Cancers

A Phase 2 study testing Anti-PRAME T-cell Receptor/Anti-CD3 scFv Fusion Protein IMC-F106C, Biopsy Procedure and Biospecimen Collection in people with Metastatic Myxoid Liposarcoma and Metastatic Synovial Sarcoma, run by National Cancer Institute (NCI).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This phase II trial studies how well brenetafusp (IMC-F106C) works in treating patients with preferentially expressed antigen of melanoma (PRAME) positive synovial sarcoma and myxoid/round cell liposarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Anti-PRAME T-cell Receptor/Anti-CD3 scFv Fusion Protein IMC-F106C, Biopsy Procedure and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
23 Nov 2026to 30 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have metastatic or unresectable synovial sarcoma or myxoid/round cell liposarcoma confirmed by molecular testing (fluorescence in situ hybridization [FISH], immunohistochemistry [IHC] for fusion protein, or next-generation sequencing [NGS])
  • Patients must be HLA-A*02:01 positive. If HLA-A*02:01 status is already known (from standard of care testing in a Clinical Laboratory Improvement Act [CLIA]-certified laboratory, e.g., in synovial sarcoma), then results from the patient record should be submitted. For patients with unknown HLA-A*02:01 status, pre-enrollment blood should be submitted for testing through the American National Red Cross Histocompatibility Laboratory Services - Philadelphia for testing
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam
  • Patients must have received at least one line of systemic therapy (neo/adjuvant chemotherapy counts as a line of therapy). The number of prior lines for metastatic or unresectable disease is limited to three (3)
  • Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of brenetafusp (IMC-F106C) in patients < 18 years of age, children are excluded from this study
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)
Show all 23Show fewer
  • Absolute neutrophil count ≥ 1,000/mcL (within 28 days of study enrollment)
  • Platelets ≥ 75,000/mcL (within 28 days of study enrollment)
  • Hemoglobin (Hgb) ≥ 9 g/dL (within 28 days of study enrollment)
  • Total bilirubin ≤ 2 × institutional upper limit of normal (ULN) (within 28 days of study enrollment)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN (within 28 days of study enrollment)
  • Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 (within 28 days of study enrollment)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with treated brain metastases are eligible if:
  • Follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
  • Treated CNS lesions are asymptomatic and radiographically stable for ≥ 2 weeks after intervention (surgery and/or radiation)
  • Participants are neurologically stable off systemic corticosteroids for at least 2 weeks prior to enrollment
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
  • The effects of brenetafusp (IMC-F106C) on the developing human fetus are unknown. For this reason and because ImmTAC agents are known to be teratogenic, women of child-bearing potential and their partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during study treatment, and for 5 months after the last dose of brenetafusp (IMC-F106C). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women should not breastfeed while taking brenetafusp (IMC-F106C) and for 5 months after completion of treatment. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 5 months after completion of brenetafusp (IMC-F106C) administration
  • Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants

Who cannot join

  • Patients who received prior treatment with an agent targeting PRAME
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
  • Patients who are receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to brenetafusp (IMC-F106C)
  • Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
  • Pregnant women are excluded from this study because brenetafusp (IMC-F106C) is an ImmTAC agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with brenetafusp (IMC-F106C), breastfeeding should be discontinued if the mother is treated with brenetafusp (IMC-F106C)
  • Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease will not be eligible for either the synovial sarcoma or myxoid liposarcoma cohorts
  • Patients who have received prior T-cell receptor T-cell (TCR-T) therapy (including prior treatment with Afamitresgene autoleucel)

About this study

Official title: A Phase 2 Trial of IMC-F106C, a PRAME Targeted ImmTAC, in Rare Cancers

This phase II trial studies how well brenetafusp (IMC-F106C) works in treating patients with preferentially expressed antigen of melanoma (PRAME) positive synovial sarcoma and myxoid/round cell liposarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Brenetafusp (IMC-F106C) is in a new class of immunotherapy called immune mobilizing monoclonal T-cell receptors against cancer (ImmTAC). Brenetafusp (IMC-F106C), may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the efficacy, as defined by overall response rate (ORR), of anti-PRAME T-cell receptor/anti-CD3 scFv fusion protein IMC-F106C (brenetafusp [IMC-F106C]) in patients with preferentially expressed antigen of melanoma (PRAME) positive synovial sarcoma and myxoid/round cell liposarcoma.

SECONDARY OBJECTIVES:

  1. To estimate progression free survival (PFS) at 3 months, 12 months, and median PFS in patients with PRAME positive synovial sarcoma and myxoid/round cell liposarcoma.

II. To assess PRAME expression by ribonucleic acid sequencing (RNAseq) at baseline and correlate PRAME expression with response to brenetafusp (IMC-F106C).

III. To correlate PFS and disease control rate (DCR) with changes in circulating tumor deoxyribonucleic acid (DNA) (ctDNA).

IV. To determine the efficacy, as defined by ORR, of brenetafusp in the intention to treat population.

  1. To estimate the PFS at 3 months, 12 months, and the median PFS in the intention to treat population.

EXPLORATORY OBJECTIVES:

  1. To identify biomarkers associated with response to brenetafusp (IMC-F106C) in patients with PRAME positive synovial sarcoma and myxoid/round cell liposarcoma.

II. To detect the pathogenic fusion protein in circulating blood and to correlate changes in circulating tumor DNA with response.

III. To correlate DCR with tumor reduction.

OUTLINE:

Patients receive brenetafusp (IMC-F106C) intravenously (IV) over 15-60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study as well as biopsy and blood sample collection on study.

After completion of study treatment, patients are followed for up to 30 days.

Being tested
Anti-PRAME T-cell Receptor/Anti-CD3 scFv Fusion Protein IMC-F106C, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging
Medical subject headings
Liposarcoma, Myxoid, Sarcoma, Synovial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-PRAME T-cell Receptor/Anti-CD3 scFv Fusion Protein IMC-F106CBiological

    Given IV

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

Study groups in NCT07686367
Study groupRoleWhat they receive
Treatment (brenetafusp [IMC-F106C])ExperimentalPatients receive brenetafusp (IMC-F106C) IV over 15-60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the study as well as biopsy and blood sample collection on study.
Receives: Biological: Anti-PRAME T-cell Receptor/Anti-CD3 scFv Fusion Protein IMC-F106C; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria. The time interval for best response evaluation is within the first 6 cycles (after the third response assessment on study), with confirmation of response allowed within 8 cycles (2 cycles after initial response). Each disease cohort will be considered separately. Will use a two-stage Minimax design.

    Measured: Up to 8 cycles (Cycle length = 21 days)

Secondary outcomes (4)

  1. Progression free survival (PFS)

    Will be calculated using a Kaplan-Meier estimator. Will report the point estimates at specified timepoints (3 months, 6 months, 12 months) and the corresponding 95% confidence interval. Will also report the median PFS.

    Measured: From study initiation to first evidence of disease progression or death, assessed at 3, 6, and 12 months

  2. Overall survival (OS)

    Will be calculated using a Kaplan-Meier estimator. Will report the point estimates at specified timepoints (3 months, 6 months, 12 months) and the corresponding 95% confidence interval. Will also report the median OS with the corresponding 95% confidence intervals (if evaluable).

    Measured: At 3, 6, and 12 months

  3. Preferentially expressed antigen of melanoma (PRAME) expression

    PRAME expression in tumor will first be measured by transcriptomic (ribonucleic acid) assessment and immunohistochemistry and then will be correlated with response to treatment. Analysis will be primarily descriptive.

    Measured: At baseline and end of treatment

  4. Changes in circulating tumor deoxyribonucleic acid (ctDNA)

    Changes in ctDNA will be correlated with the clinical outcomes of PFS and disease control rate (DCR).

    Measured: At baseline, cycle 2 day 1, and end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start23 Nov 2026 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07686367
Sponsor's protocol ID
NCI-2026-04705
Other IDs
NCI-2026-04705, 10740, 10740, UM1CA186709
Status last verified
Sep 2026
First submitted
3 Jul 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-PRAME T-cell Receptor/Anti-CD3 scFv Fusion Protein IMC-F106C, Biopsy Procedure and Biospecimen Collection in people with Metastatic Myxoid Liposarcoma and Metastatic Synovial Sarcoma, run by National Cancer Institute (NCI).

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 8 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Overall response rate (time frame: Up to 8 cycles (Cycle length = 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07686367.

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 25 Sep 2026.

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