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New antibody drug targets Hard-to-Treat cancers in early trial

NCT ID NCT06402201

Disease control Sponsor: CDR-Life AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new drug called CDR404 in up to 42 adults with advanced solid tumors that have a specific marker (MAGE-A4) and tissue type (HLA-A*02:01). The drug is designed to help the body's immune T-cells find and attack cancer cells. The main goals are to check safety, find the right dose, and see if the drug can shrink tumors.

What this could mean

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

Active substance
CDR404 (a bispecific antibody that engages T-cells to attack cancer cells)
What this could lead to
If it works, this could point toward a new treatment option for certain hard-to-treat solid tumors that express the MAGE-A4 protein.
What could go wrong
This is a very early, first-in-human trial with only 42 participants, so safety and effectiveness are not yet known. The treatment may cause side effects or fail to shrink tumors.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 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. Provision of written informed consent 2. HLA-A\*02:01 positive 3. MAGE-A4 positive tumor 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \[ECOG PS\] 0 or 1 5. Selected advanced solid tumors 6. Relapsed from, refractory to, or intolerant of standard therapy 7. Measurable disease per RECIST v1.1 8. Adequate organ function 9. If applicable, must agree to use highly effective contraception Exclusion Criteria: 1. Symptomatic or untreated central nervous system metastasis 2. Inadequate washout from prior anticancer therapy 3. Significant ongoing toxicity from prior anticancer treatment 4. Recent surgery 5. Clinically significant cardiac disease 6. Active infection requiring systemic antibiotic treatment 7. Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes 8. Active hepatitis B virus (HBV) or hepatitis C virus (HBC) 9. Ongoing treatment with systemic steroids or other immunosuppressive therapies 10. Significant secondary malignancy 11. History of chronic or recurrent active autoimmune disease requiring treatment 12. Uncontrolled intercurrent illness 13. Pregnancy or lactation.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Select advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cliniques Universitaires Saint-Luc, UCL Ouvain

    RECRUITING

    Brussels, 1200, Belgium

  • Hospital 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO)

    RECRUITING

    Barcelona, 08908, Spain

  • Institut Jules Bordet

    RECRUITING

    Brussels, 1070, Belgium

  • Instituto de Investigacion Sanitaria (INCLIVA)

    RECRUITING

    Valencia, 46026, Spain

  • Isituto Europeo di Oncologia (IEO)

    RECRUITING

    Milan, 20141, Italy

  • Istituto Clinico Humanitas

    RECRUITING

    Milan, 20089, Italy

  • Pennsylvania Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19106, United States

  • Providence Cancer Institute

    RECRUITING

    Portland, Oregon, 97213, United States

    Contact Email: •••••@•••••

  • Rigshospitalet

    RECRUITING

    Copenhagen, DK-2100, Denmark

  • Royal Marsden Hospital

    RECRUITING

    Sutton, London, SM2 5PT, United Kingdom

  • START Madrid

    RECRUITING

    Madrid, 28050, Spain

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Antwerp, 2650, Belgium

    Contact Email: •••••@•••••

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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