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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor: T.O.A.D. Oncology SA
Study ID: NCT07258407
Phase: PHASE1/PHASE2
Status: Recruiting

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Conditions

Metastatic Castration-Resistant Prostatic Cancer

Eligibility Criteria

Sex: MALE
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

TD001 — DRUG
Intravenous (IV) infusion at protocol-defined doses and schedules until disease progression or other reason to end treatment

Study Details

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).

Key Dates

Start date: Jan 30, 2026
Status verified: Dec 2025
Primary completion: Mar 31, 2028
Completion: Mar 31, 2029

Study Design

Enrollment: 180 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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)

Primary Outcome Measure

Maximum tolerated dose (dose escalation) [ Time Frame: Treatment + follow-up (estimated 9 months) ]

Central Contacts

TOAD Clinical Operations
41 41 556 64 01
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Yale University, Yale Cancer Center	New Haven	Connecticut	06520	-

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Yale University, Yale Cancer Center· New Haven, CT