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NCT07258407 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Castration-Resistant Prostatic Cancer, sponsored by T.O.A.D. Oncology.

Recruiting
Registry status
Phase 1
Development phase
180
Enrollment target
4
Study locations

NCT07258407: Recruiting Phase 1 study of Metastatic Castration-Resistant Prostatic Cancer, sponsored by T.O.A.D. Oncology.

NCT07258407 is a Phase 1 study of Metastatic Castration-Resistant Prostatic Cancer that is actively recruiting participants, run by T.O.A.D. Oncology. The registered enrollment target is 180 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07258407, a Phase 1 study of Metastatic Castration-Resistant Prostatic Cancer, is actively recruiting participants, sponsored by T.O.A.D. Oncology.

RECRUITING
Registry status
Phase 1
Development phase
180 participants
Enrollment target
4
Study locations

Study 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).

Primary Outcome

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

Interventions

  • DRUG TD001

Study Locations (4)

Other

  • Institut Bergonié - Bordeaux
  • Hôpital Paris Saint Joseph - Paris
  • Institut Gustave Roussy - Villejuif

Connecticut

  • Yale University, Yale Cancer Center - New Haven

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2026-01-30
Est. Completion 2029-03
Phase Phase 1
T.O.A.D. Oncology

1 total trials

What NCT07258407 shows while recruiting

NCT07258407 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher).

The record links to 1 condition, with Metastatic Castration-Resistant Prostatic Cancer appearing as the primary indexed condition, and to 1 intervention - of which TD001 is the first listed.

NCT07258407 reports a single indexed study location in Other, Connecticut.

Frequently Asked Questions

What is clinical trial NCT07258407 about?

NCT07258407 is a clinical study titled "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).

What is the current status of trial NCT07258407?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2026-01-30. Estimated completion is 2029-03.

What conditions does trial NCT07258407 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostatic Cancer.

What interventions are being tested in trial NCT07258407?

The interventions under investigation include: TD001 (DRUG).

Who is sponsoring clinical trial NCT07258407?

This trial is sponsored by T.O.A.D. Oncology, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07258407 being conducted?

This trial has 4 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT07258407's enrollment target sits among peer trials

180 300th of 2000 higher than 1,690 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07258407, the US trial registry maintained by the National Library of Medicine. NCT07258407 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.