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

May 28, 2026 updated by: T.O.A.D. Oncology SA

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a first-in-human, open-label, multicenter Phase 1/2 study with a dose escalation part to determine recommended Phase 2 doses (RP2Ds) of TD001 for further evaluation in an expansion part of the study. Multiple dosing schedules may be evaluated. The safety and preliminary efficacy endpoints of this study will support dose optimization in this patient population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonie
      • Paris, France, 75014
        • Recruiting
        • Hôpital Paris Saint Joseph
      • Villejuif, France, 94805
        • Recruiting
        • Institut Gustave Roussy
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron Institute of Oncology
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Not yet recruiting
        • Yale University, Yale Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose escalation
Sequential groups of participants receive TD001 at escalating doses
Drug: TD001
Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment
Experimental: RP2D dose expansion
Groups of participants receive TD001 at the recommended Phase 2 doses (RP2Ds)
Drug: TD001
Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recommended Phase 2 doses (dose escalation)
Time Frame: 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
Treatment + follow-up (estimated 9 months)
Safety/tolerability - incidence of AEs, SAEs, abnormal laboratory parameters (dose escalation + expansion)
Time Frame: Treatment + follow-up (estimated 21 months)
AEs, SAEs, abnormal laboratory parameters by type, severity, and relatedness as assessed by CTCAE v6.0
Treatment + follow-up (estimated 21 months)
Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion)
Time Frame: Treatment + follow-up (estimated 21 months)
AEs by type, severity, and relatedness as assessed by CTCAE v6.0
Treatment + follow-up (estimated 21 months)
Maximum tolerated dose (dose escalation)
Time Frame: 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
Treatment + follow-up (estimated 9 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma PK - AUC
Time Frame: Estimated 6-8 months
Area under the concentration-time curve for total ADC, total antibody, and unconjugated payload
Estimated 6-8 months
Plasma PK - AUClast
Time Frame: Estimated 6-8 months
Area under concentration-time curve from time zero to the last measurable concentration for total ADC, total antibody, and unconjugated payload
Estimated 6-8 months
Plasma PK - Cmax
Time Frame: Estimated 6-8 months
Maximum concentration for total ADC, total antibody, and unconjugated payload
Estimated 6-8 months
Plasma PK - Tmax
Time Frame: Estimated 6-8 months
Time to maximum concentration for total ADC, total antibody, and unconjugated payload
Estimated 6-8 months
Plasma PK - T1/2
Time Frame: Estimated 6-8 months
Terminal elimination half-life for total ADC, total antibody, and unconjugated payload
Estimated 6-8 months
Plasma PK - Ctrough
Time Frame: Estimated 6-8 months
Trough concentration for total ADC, total antibody, and unconjugated payload
Estimated 6-8 months
PSA progression-free survival
Time Frame: Treatment + follow-up (estimated 21 months)
Per PCWG3
Treatment + follow-up (estimated 21 months)
Radiographic progression-free survival
Time Frame: Treatment + follow-up (estimated 21 months)
per PCWG3-modified RECIST 1.1
Treatment + follow-up (estimated 21 months)
Duration of response
Time Frame: Treatment + follow-up (estimated 21 months)
For PSA and radiographic response
Treatment + follow-up (estimated 21 months)
Disease control rate
Time Frame: Treatment (estimated 8 months)
Best response of CR, PR or SD
Treatment (estimated 8 months)
Overall survival
Time Frame: Treatment + follow-up (estimated 21 months)
Treatment + follow-up (estimated 21 months)
Immunogenicity - prevalance and incidence of ADAs
Time Frame: Treatment period + follow-up (estimated 9 months)
ADAs against TD001 prior to first dose and at any time on treatment
Treatment period + follow-up (estimated 9 months)
Plasma PK - AUCtau
Time Frame: Estimated 6-8 months
Area under concentration-time curve from time zero to the end of the dosing interval for total ADC, total antibody, and unconjugated payload
Estimated 6-8 months
PSA50 response rate
Time Frame: Treatment (estimated 8 months)
≥50% PSA decrease from baseline, per PCWG3
Treatment (estimated 8 months)
Overall response rate
Time Frame: Treatment (estimated 8 months)
Best response of CR or PR per PCWG3-modified RECIST 1.1
Treatment (estimated 8 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
T.O.A.D. Oncology SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TD001-101
  • 2025-523273-41-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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