Metastatic Castration-Resistant Prostatic CancerPhase 1/2NCT07258407
A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer
A Phase 1/2 study testing TD001 in people with Metastatic Castration-Resistant Prostatic Cancer, run by T.O.A.D. Oncology SA at 7 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostatic Cancer
- What is being tested?
- TD001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 30 Jan 2026to Mar 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 5 countries
France3 sites, 3 recruiting
- Recruiting
Institut Bergonié
Bordeaux, 33076
- Recruiting
Hôpital Paris Saint Joseph
Paris, 75014
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
United States1 site, 1 recruiting
- Not yet recruiting
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron Institute of Oncology
Barcelona, 08035
About this study
Official 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
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).
Read the 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.
- Being tested
- TD001
- Keywords
- CRPC, PSMA, prostate-specific membrane antigen
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD001Drug
Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Sequential groups of participants receive TD001 at escalating doses Receives: Drug: TD001 |
| RP2D dose expansion | Experimental | Groups of participants receive TD001 at the recommended Phase 2 doses (RP2Ds) Receives: Drug: TD001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (dose escalation)
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
Measured: Treatment + follow-up (estimated 9 months)
Recommended Phase 2 doses (dose escalation)
Incidence of AEs, SAEs, abnormal laboratory parameters, TD001 discontinuation or modification due to AEs, as assessed by CTCAE v6.0
Measured: Treatment + follow-up (estimated 9 months)
Safety/tolerability - incidence of AEs, SAEs, abnormal laboratory parameters (dose escalation + expansion)
AEs, SAEs, abnormal laboratory parameters by type, severity, and relatedness as assessed by CTCAE v6.0
Measured: Treatment + follow-up (estimated 21 months)
Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion)
AEs by type, severity, and relatedness as assessed by CTCAE v6.0
Measured: Treatment + follow-up (estimated 21 months)
Secondary outcomes (15)
Plasma PK - AUC
Area under the concentration-time curve for total ADC, total antibody, and unconjugated payload
Measured: Estimated 6-8 months
Plasma PK - AUClast
Area under concentration-time curve from time zero to the last measurable concentration for total ADC, total antibody, and unconjugated payload
Measured: Estimated 6-8 months
Plasma PK - AUCtau
Area under concentration-time curve from time zero to the end of the dosing interval for total ADC, total antibody, and unconjugated payload
Measured: Estimated 6-8 months
Plasma PK - Cmax
Maximum concentration for total ADC, total antibody, and unconjugated payload
Measured: Estimated 6-8 months
Plasma PK - Tmax
Time to maximum concentration for total ADC, total antibody, and unconjugated payload
Measured: Estimated 6-8 months
Plasma PK - T1/2
Terminal elimination half-life for total ADC, total antibody, and unconjugated payload
Measured: Estimated 6-8 months
Plasma PK - Ctrough
Trough concentration for total ADC, total antibody, and unconjugated payload
Measured: Estimated 6-8 months
PSA50 response rate
≥50% PSA decrease from baseline, per PCWG3
Measured: Treatment (estimated 8 months)
Overall response rate
Best response of CR or PR per PCWG3-modified RECIST 1.1
Measured: Treatment (estimated 8 months)
PSA progression-free survival
Per PCWG3
Measured: Treatment + follow-up (estimated 21 months)
Radiographic progression-free survival
per PCWG3-modified RECIST 1.1
Measured: Treatment + follow-up (estimated 21 months)
Duration of response
For PSA and radiographic response
Measured: Treatment + follow-up (estimated 21 months)
Disease control rate
Best response of CR, PR or SD
Measured: Treatment (estimated 8 months)
Overall survival
Measured: Treatment + follow-up (estimated 21 months)
Immunogenicity - prevalance and incidence of ADAs
ADAs against TD001 prior to first dose and at any time on treatment
Measured: Treatment period + follow-up (estimated 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start30 Jan 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant Prostatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3 + 3 dose escalation design followed by RP2D cohort expansion
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- T.O.A.D. Oncology SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258407
- Sponsor's protocol ID
- TD001-101
- Other IDs
- 2025-523273-41-00, 2025
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07258407
- Acronym / sponsor ID
- TD001-101
- Keywords
- CRPC, PSMA, prostate-specific membrane antigen
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- T.O.A.D. Oncology SAIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3 + 3 dose escalation design followed by RP2D cohort expansion
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: TD001Sequential groups of participants receive TD001 at escalating doses |
| RP2D dose expansion | Experimental | Drug: TD001Groups of participants receive TD001 at the recommended Phase 2 doses (RP2Ds) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD001Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment | Drug | Dose escalation, RP2D dose expansion |
Primary outcome
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
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
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
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
15 secondary outcomes
Plasma PK - AUC
Time frame: Estimated 6-8 months
Plasma PK - AUClast
Time frame: Estimated 6-8 months
Plasma PK - AUCtau
Time frame: Estimated 6-8 months
Plasma PK - Cmax
Time frame: Estimated 6-8 months
Plasma PK - Tmax
Time frame: Estimated 6-8 months
Plasma PK - T1/2
Time frame: Estimated 6-8 months
Plasma PK - Ctrough
Time frame: Estimated 6-8 months
PSA50 response rate
Time frame: Treatment (estimated 8 months)
Overall response rate
Time frame: Treatment (estimated 8 months)
PSA progression-free survival
Time frame: Treatment + follow-up (estimated 21 months)
Radiographic progression-free survival
Time frame: Treatment + follow-up (estimated 21 months)
Duration of response
Time frame: Treatment + follow-up (estimated 21 months)
Disease control rate
Time frame: Treatment (estimated 8 months)
Overall survival
Time frame: Treatment + follow-up (estimated 21 months)
Immunogenicity - prevalance and incidence of ADAs
Time frame: Treatment period + follow-up (estimated 9 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TD001 in people with Metastatic Castration-Resistant Prostatic Cancer, run by T.O.A.D. Oncology SA at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, United States, Australia, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TOAD Clinical Operations (41 41 556 64 01, contact@toadonco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (dose escalation) (time frame: Treatment + follow-up (estimated 9 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.