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New antibody takes on Hard-to-Treat cancers

NCT ID NCT04243499

Disease control Sponsor: ImCheck Therapeutics, an Ipsen company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 6 times

Summary

This early-stage trial tests a new drug called ICT01, a lab-made antibody, in 292 people with advanced cancers that have not responded to standard treatments. The drug is given alone or with another cancer drug (Keytruda). The main goals are to check safety and see if the drug can control tumor growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ICT01 (a monoclonal antibody targeting BTN3A)
What this could lead to
If successful, this could point toward a new treatment option for advanced cancers that have stopped responding to standard therapies.
What could go wrong
This is an early Phase 1/2 trial, so the main goal is safety, not proof of effectiveness. It may not work for many patients, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

293 people

The number who actually took part.

Started

Mar 2020

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily signed informed consent form. 2. Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer, including: Group A: bladder, breast, colon, gastric, melanoma, ovarian, prostate and PDAC Group B: hematologic malignancies including acute myeloid leukemia, acute lymphocytic leukemia, Diffuse large B cell lymphoma and follicular lymphoma Group C: melanoma, cervical, bladder, gastric, head and neck SCC, and lymphoma (according to the approved package labeling of the ICI) Part 2, Group D: Ovarian cancer (2L/3L) with baseline g9d2 T cells \> 20K Part 2, Group E: metastatic castrate resistant prostate cancer (2L/3L) with baseline g9d2 T cells \> 20K Part 2, Group F: newly diagnosed AML starting venetoclax/azacitidine Part 2, Group G: checkpoint-refractory metastatic melanoma with g9d2 T cells \>5K Part 2, Group H: chemotx-refractory or Pt-ineligible urotherlial cancer (bladder) with g9d2 T cells \>5K Part 2, Group I: checkpoint-refractory, metastatic HNSCC with g9d2 T cells \>5K 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 4. Life expectancy \> 3 months as assessed by the Investigator 5. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or \>5% marrow blasts Exclusion Criteria: 1. Any malignancy of Vγ9Vδ2 T cell origin 2. Any anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment (does not apply to patients receiving ICI for the combination arm) 3. Treatment with investigational drug(s) within 28 days before study treatment 4. Systemic steroids at a daily dose of \> 10 mg of prednisone, \> 2 mg of dexamethasone or equivalent, for the last 28 days and need for ongoing treatment. 5. Patients with rapidly progressing disease defined as advanced/metastatic, symptomatic, visceral spread, with a risk of life-threatening complications in the short term (e.g., during Screening Period/ treatment washout) that includes patients with massive uncontrolled effusions pleural, pericardial, peritoneal, pulmonary lymphangitis, and over 50% liver involvement 6. Ongoing immune-related adverse events (irAEs) and/or AEs ≥grade 2 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with replacement hormone therapy. 7. Within 4 weeks of major surgery 8. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months 9. Primary or secondary immune deficiency 10. Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematopoietic/lymphoid cancer Solid tumor, adult

Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • CHU Lyon

    Lyon, France

  • CHU Nantes

    Nantes, 44093, France

  • CHU Poitiers

    Poitiers, 86000, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Hospitalier Lyon Sud

    Lyon, 69310, France

  • Centre Lyon Berard

    Lyon, France

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Gustave Roussy

    Paris, France

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Haut Leveque

    Bordeaux, 33600, France

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Institut Bergonie

    Bordeaux, 33000, France

  • Institut Curie

    Paris, 75248, France

  • Institut Jules Bordet

    Brussels, Belgium

  • Institut Paoli-Calmettes

    Marseille, France

  • Institute of Cancer Research

    London, United Kingdom

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre

    Glasgow, United Kingdom

  • Pitie-Salpetriere

    Paris, 75013, France

  • START Barcelone HM Nou Delfos

    Barcelona, 08023, Spain

  • START Madrid-FJD, Hospital Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • US Oncology Research

    Irving, Texas, 75063, United States

  • University Carl Gustav Carus Clinical Trial Unit

    Dresden, Germany

  • University of Washington

    Seattle, Washington, 98133, United States

  • Vall d'Hebron Instiute of Oncology

    Barcelona, Spain

  • Yale Cancer Center

    New Haven, Connecticut, 06511, United States

  • universitatklinikum Wurburg

    Würzburg, Germany

More trials for these conditions

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