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RecruitingLast updated: 15 May 2026

Evaluating a new targeted treatment called TD001 for people with PSMA-Expressing metastatic castration-resistant prostate cancer (mCRPC)A Phase 1/2 Dose Escalation Trial With Administration Schedule Exploration Evaluating Single Agent TD001, a PSMA-Targeted Antibody-Drug Conjugate, in Patients With PSMA-Expressing Metastatic Castration-Resistant Prostate Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Clinical summary

Summary

Testing a new treatment called TD001 in people with advanced prostate cancer that has spread and continues to grow despite hormone therapy (castration-resistant). TD001 is a type of targeted drug designed to find cancer cells and deliver chemotherapy directly to them.

The study will look at how safe the treatment is, how well it is tolerated, how the drug moves through the body, and whether it may help shrink or control the cancer. Researchers will start with lower doses and gradually increase them to find the best dose to use in future studies.

 

Conditions

This trial is treating people with metastatic castration-resistant prostate cancer that expresses PSMA and has progressed on prior treatment

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

T.O.A.D. Oncology SA

Scientific Title

A Phase 1/2 Dose Escalation Trial With Administration Schedule Exploration Evaluating Single Agent TD001, a PSMA-Targeted Antibody-Drug Conjugate, in Patients With PSMA-Expressing Metastatic Castration-Resistant Prostate Cancer

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