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TD001 for Metastatic Prostate Cancer

This study is testing a new drug called TD001 in men with metastatic castration-resistant prostate cancer (CRPC). This is prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone therapy. TD001 is an antibody-drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells that have a specific marker called PSMA. The main goals are to find a safe dose of TD001 and see how well it's tolerated. You may be able to join if you have PSMA-expressing metastatic CRPC that has progressed, have at least one measurable tumor, and meet other health requirements. The study is currently enrolling up to 180 participants.

Study design
This is a first-in-human, open-label study, meaning both you and the study team will know you are receiving TD001. It will involve a dose escalation part to find the best dose, followed by an expansion part, and plans to enroll 180 participants.
What's involved
You would receive TD001 as an intravenous (IV) infusion at specific doses and schedules until your disease progresses or treatment needs to stop.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for an estimated 21 months after treatment, and the maximum tolerated dose will be assessed for an estimated 9 months.

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NCT07258407

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
T.O.A.D. Oncology SA
~180 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:TD001

At a glance

Recruiting sites
6 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (dose escalation)
Measured over Treatment + follow-up (estimated 9 months)
+3 more outcomes measured

Conditions

Metastatic Castration-Resistant Prostatic Cancer

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Where it's being run

7 sites across 5 states
France3
Connecticut1
Victoria1
Ontario1
Spain1

Who to contact

TOAD Clinical Operations
[email protected]
41 41 556 64 01
Email the study team

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Eligibility criteria

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

What this trial measures

  • Maximum tolerated dose (dose escalation)Treatment + follow-up (estimated 9 months)

    Number of participants with dose-limiting toxicity; incidence of adverse events (AEs), serious AEs (SAEs), abnormal laboratory parameters, TD001 discontinuation or modification due to AEs, as assessed by CTCAE v6.0

  • Recommended Phase 2 doses (dose escalation)Treatment + follow-up (estimated 9 months)

    Incidence of AEs, SAEs, abnormal laboratory parameters, TD001 discontinuation or modification due to AEs, as assessed by CTCAE v6.0

  • Safety/tolerability - incidence of AEs, SAEs, abnormal laboratory parameters (dose escalation + expansion)Treatment + follow-up (estimated 21 months)

    AEs, SAEs, abnormal laboratory parameters by type, severity, and relatedness as assessed by CTCAE v6.0

  • Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion)Treatment + follow-up (estimated 21 months)

    AEs by type, severity, and relatedness as assessed by CTCAE v6.0