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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT07258407Sponsor: T.O.A.D. Oncology SALast updated: 2026-05-29

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).

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.

Arms & interventions

  • DrugTD001

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

Outcome measures

Primary

  • 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Secondary

  • 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)

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Yale University, Yale Cancer Center

New Haven, Connecticut, 06520

Not Yet Recruiting
A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer | Cancerify