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NCT07189403 · ClinicalTrials.gov registry record · Phase 1

A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Advanced or Metastatic Adrenocortical Carcinoma, sponsored by Daiichi Sankyo.

Recruiting
Registry status
Phase 1
Development phase
40
Enrollment target
6
Study locations

NCT07189403: Recruiting Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Advanced or Metastatic Adrenocortical Carcinoma, sponsored by Daiichi Sankyo.

NCT07189403 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Advanced or Metastatic Adrenocortical Carcinoma that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 40 participants, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (80% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07189403, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Advanced or Metastatic Adrenocortical Carcinoma, is actively recruiting participants, sponsored by Daiichi Sankyo.

RECRUITING
Registry status
Phase 1
Development phase
40 participants
Enrollment target
6
Study locations

Study Summary

This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.

Primary Outcome

AEs will be graded using NCI-CTCAE v5.0. A DLT is defined as any TEAE not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc. that occurs during the DLT evaluation period (Day 1 to the end of Cycle 1) and is Grade ≥3 with exceptions as further defined. TEAEs are defined as those AEs with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 30 days after the last dose date of trial intervention).

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer Advanced or Metastatic Adrenocortical Carcinoma

Interventions

  • DRUG DS9051b

Study Locations (6)

Other

  • Oncopole Claudius Regaud - Toulouse
  • Centre Oscar Lambret - Villejuif
  • Royal Marsden - London

Florida

  • Florida Cancer Specialists - Sarasota

New York

  • Columbia University - New York

Rhode Island

  • Brown University - Providence

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2025-11-04
Est. Completion 2028-03-01
Phase Phase 1
Daiichi Sankyo

236 total trials

What NCT07189403 shows while recruiting

NCT07189403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (80% lower).

The record links to 2 conditions, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which DS9051b is the first listed.

NCT07189403 lists 6 locations in 4 states (Other, Florida, New York).

Frequently Asked Questions

What is clinical trial NCT07189403 about?

NCT07189403 is a clinical study titled "A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer". This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.

What is the current status of trial NCT07189403?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-11-04. Estimated completion is 2028-03-01.

What conditions does trial NCT07189403 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer, Advanced or Metastatic Adrenocortical Carcinoma.

What interventions are being tested in trial NCT07189403?

The interventions under investigation include: DS9051b (DRUG).

Who is sponsoring clinical trial NCT07189403?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07189403 being conducted?

This trial has 6 study locations across Florida, New York, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Castration-Resistant Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07189403's enrollment target sits among peer trials

40 48th of 69 higher than 20 of 69 other Metastatic Castration-Resistant Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer 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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More recruiting context for NCT07189403

Source: ClinicalTrials.gov NCT07189403, the US trial registry maintained by the National Library of Medicine. NCT07189403 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.