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New Antibody-Drug conjugate takes aim at Hard-to-Treat prostate cancer

NCT ID NCT07258407

Disease control Sponsor: T.O.A.D. Oncology SA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new drug called TD001 in men with a type of advanced prostate cancer that has stopped responding to hormone therapy. TD001 is an antibody-drug conjugate designed to deliver a cancer-killing payload directly to prostate cancer cells that have a specific marker (PSMA). The trial will enroll 180 participants to find the safest dose and schedule, and to see if the drug can slow the cancer.

What this could mean

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

Active substance
TD001 (an antibody-drug conjugate that targets PSMA on prostate cancer cells)
What this could lead to
If it works, this could point toward a new treatment option for men with advanced prostate cancer that has stopped responding to hormone therapy.
What could go wrong
This is an early phase 1/2 trial, so the main goals are safety and finding the right dose. It is too soon to know if TD001 will shrink tumors or improve survival, 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

About 180 people

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

Started

Jan 2026

Expected to finish

Mar 2029

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

Male participants only

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: * Patient must fully understand the study requirements and voluntarily sign informed consent. * PSMA-expressing metastatic CRPC with documented progression based on serum PSA, RECIST 1.1 with PCWG3, and/or bone disease. * At least one measurable metastatic lesion per RECIST 1.1. * Adequate organ function. * Prior orchiectomy and/or ongoing androgen deprivation therapy. * Prior treatment with at least one androgen receptor pathway inhibitor (ARPI) drug. Exclusion Criteria: * Previous treatment with strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemi-body irradiation, within 6 months before treatment. * Systemic anticancer therapy including an investigational agent within 28 days before treatment. * Known hypersensitivity to the components of TD001, its analogs, or excipients. * Current dyspnea at rest, other disease requiring continuous oxygen therapy, or history of pneumonitis

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

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

Metastatic castration-resistant prostatic cancer

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

    7 sites in 5 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Hôpital Paris Saint Joseph

    RECRUITING

    Paris, 75014, France

  • Institut Bergonié

    RECRUITING

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Vall d'Hebron Institute of Oncology

    RECRUITING

    Barcelona, 08035, Spain

  • Yale University, Yale Cancer Center

    NOT_YET_RECRUITING

    New Haven, Connecticut, 06520, United States

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