Recruiting
Phase 1
Phase 2

TD001

Sponsor:

T.O.A.D. Oncology SA

Code:

NCT07258407

Conditions

Metastatic Castration-Resistant Prostatic Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TD001

Study Details

Brief 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).

Conditions

Metastatic Castration-Resistant Prostatic Cancer

Study ID

NCT07258407

Start date

Jan 30, 2026

Status verified date

Dec, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

180 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation

Sequential groups of participants receive TD001 at escalating doses

experimental: RP2D dose expansion

Groups of participants receive TD001 at the recommended Phase 2 doses (RP2Ds)

Interventions

TD001

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

Primary outcome measure

  • Maximum tolerated dose (dose escalation) [ Time Frame: Treatment + follow-up (estimated 9 months) ]
  • Recommended Phase 2 doses (dose escalation) [ Time Frame: 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) ]
  • Safety/tolerability - incidence of TD001 discontinuation or modification due to AEs (dose escalation + expansion) [ Time Frame: Treatment + follow-up (estimated 21 months) ]

Central Contacts and Locations

Central contacts

TOAD Clinical Operations

41 41 556 64 01contact@toadonco.com

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

T.O.A.D. Oncology SA

Last update posted

May 29, 2026

Last verified

Dec, 2025

Keywords

  • CRPC
  • PSMA
  • prostate-specific membrane antigen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by T.O.A.D. Oncology SA on 2026-05-29.