RecruitingPhase 1/2

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

United States, Australia, Canada180 participantsStarted 2026-01-30

Plain-language summary

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).

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum tolerated dose (dose escalation)

Timeframe: Treatment + follow-up (estimated 9 months)

Recommended Phase 2 doses (dose escalation)

Timeframe: Treatment + follow-up (estimated 9 months)

Safety/tolerability - incidence of AEs, SAEs, abnormal laboratory parameters (dose escalation + expansion)

Timeframe: Treatment + follow-up (estimated 21 months)

Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion)

Timeframe: Treatment + follow-up (estimated 21 months)

Trial details

NCT IDNCT07258407

SponsorT.O.A.D. Oncology SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-03

Contact for this trial

TOAD Clinical Operations

41 41 556 64 01 contact@toadonco.com

View on ClinicalTrials.gov More Metastatic Castration-Resistant Prostatic Cancer trials

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum tolerated dose (dose escalation)

Timeframe: Treatment + follow-up (estimated 9 months)

Recommended Phase 2 doses (dose escalation)

Timeframe: Treatment + follow-up (estimated 9 months)

Safety/tolerability - incidence of AEs, SAEs, abnormal laboratory parameters (dose escalation + expansion)

Timeframe: Treatment + follow-up (estimated 21 months)

Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion)

Timeframe: Treatment + follow-up (estimated 21 months)