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NCT Number: NCT07258407

A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic 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).

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Key information

Conditions

Metastatic Castration-Resistant Prostatic Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TD001

Drug

Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Plasma PK - AUC

    Time frame: Estimated 6-8 months

    Area under the concentration-time curve for total ADC, total antibody, and unconjugated payload

  2. 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

  3. 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

  4. Plasma PK - Cmax

    Time frame: Estimated 6-8 months

    Maximum concentration for total ADC, total antibody, and unconjugated payload

  5. Plasma PK - Tmax

    Time frame: Estimated 6-8 months

    Time to maximum concentration for total ADC, total antibody, and unconjugated payload

  6. Plasma PK - T1/2

    Time frame: Estimated 6-8 months

    Terminal elimination half-life for total ADC, total antibody, and unconjugated payload

  7. Plasma PK - Ctrough

    Time frame: Estimated 6-8 months

    Trough concentration for total ADC, total antibody, and unconjugated payload

  8. PSA50 response rate

    Time frame: Treatment (estimated 8 months)

    ≥50% PSA decrease from baseline, per PCWG3

  9. Overall response rate

    Time frame: Treatment (estimated 8 months)

    Best response of CR or PR per PCWG3-modified RECIST 1.1

  10. PSA progression-free survival

    Time frame: Treatment + follow-up (estimated 21 months)

    Per PCWG3

  11. Radiographic progression-free survival

    Time frame: Treatment + follow-up (estimated 21 months)

    per PCWG3-modified RECIST 1.1

  12. Duration of response

    Time frame: Treatment + follow-up (estimated 21 months)

    For PSA and radiographic response

  13. Disease control rate

    Time frame: Treatment (estimated 8 months)

    Best response of CR, PR or SD

  14. Overall survival

    Time frame: Treatment + follow-up (estimated 21 months)

  15. 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

Study contacts

Contact information is provided by the study sponsor or research team.

TOAD Clinical Operations

CONTACT

[email protected]

41 41 556 64 01

Sponsors and collaborators

Lead sponsor

T.O.A.D. Oncology SA

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 2, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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