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RecruitingPhase 1 / Phase 2

A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests TD001, a drug linked to an antibody that targets a protein called PSMA. It is for men whose prostate cancer has spread, has PSMA, and keeps growing despite treatment to lower testosterone. The study checks safety, side effects, drug levels in the body, and early signs that TD001 may fight cancer.

This study will evaluate the safety, tolerability, drug levels (pharmacokinetics) and preliminary antitumor activity of TD001, an antibody-drug conjugate (ADC) targeting prostate-specific membrane antigen (PSMA), in men with metastatic PSMA-expressing castration-resistant prostate cancer (CRPC).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Understand the study requirements and freely sign a consent form.
  • Have prostate cancer that has spread, has PSMA, and is getting worse despite treatment to lower testosterone, as shown by blood tests or scans.
  • Have at least one area of cancer spread that can be measured on a scan.
  • Have organs that work well enough for the study.
  • Have had surgery to remove the testicles, be taking treatment to lower testosterone, or both.
  • Have taken at least one drug that blocks the action of male hormones, called an ARPI.

Who can't join

  • Received strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or radiation to half the body within 6 months before treatment.
  • Received cancer treatment that acts throughout the body, including an experimental drug, within 28 days before treatment.
  • Have a known allergy to TD001, similar drugs, or any of its ingredients.
  • Have shortness of breath while resting, need oxygen all the time for another illness, or have had pneumonitis (lung inflammation).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

CT