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

NCT07189403 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: DS9051-0792025-521886-28-00
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 6

Brief Summary

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

Conditions

Metastatic Castration-resistant Prostate Cancer; Advanced or Metastatic Adrenocortical Carcinoma

Keywords

Advanced or metastatic adrenocortical carcinoma; Metastatic castration-resistant prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Dose-limiting Toxicities (DLTs), Treatment-emergent Adverse Events (TEAEs), TEAEs Associated With Treatment Discontinuation, Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) - All Patients

  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).

  Baseline up to 50 months

Secondary Outcomes (5)

• Objective Response by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

  Baseline up to 50 months

• Disease Control by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

  Baseline up to 50 months

• Clinical Benefit by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

  Baseline up to 50 months

• Duration of Response by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

  From date of initial response (CR or PR) to the earlier date of the first objective documentation of radiographic disease progression (based on investigator assessment per RECIST v1.1) or death due to any cause, up to 50 months

• Progression-free Survival by Investigator Assessment in Participants With Advanced or Metastatic Adrenocortical Carcinoma

  From the date of the first administration of trial intervention to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to 50 months

Study Arms (1)

DS9051b

EXPERIMENTAL

Participants with advanced or metastatic adrenocortical carcinoma and metastatic castration-resistant prostate cancer who will receive DS9051b.

Drug: DS9051b

Interventions

DS9051b DRUG

Administered orally

DS9051b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign and date the main ICF, prior to the start of any trial-specific procedures.
• Adults ≥18 years of age at the time the ICF is signed (Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old)
• Histologically confirmed diagnosis of ACC or adenocarcinoma of the prostate
• ECOG PS of 0 or 1 assessed no more than 14 days prior to C1D1. (ECOG PS of 2 due to cancer pain is acceptable)
• Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to C1D1 as defined below. Organ and bone marrow function criteria must also be met when laboratory tests are repeated within 3 days of initiation of trial intervention as appropriate.
• Treatment with at least 1 line (or more) of ARPI therapy for CSPC or in CRPC for a minimum of 12 weeks (eg, abiraterone, enzalutamide, darolutamide, apalutamide).
• Treatment with at least 1 line (or more) of chemotherapy, having ineligibility for chemotherapy or refusal of chemotherapy.
• Documented disease progression by one or more of the following criteria:
• PSA progression as defined by PCWG3 criteria.
• Soft tissue disease progression as defined by RECIST 1.1 criteria.
• Bone disease progression as defined by Prostate Cancer Working Group 3 criteria.
• An individual who meets any of the following criteria will be excluded from participation in this trial:
• History of pituitary gland dysfunction.
• Active or uncontrolled autoimmune disease requiring systemic treatment.
• Any medical condition (other than the cancer disease) requiring a dose of concurrent systemic corticosteroid treatment greater than 5 mg of prednisone and/or 100 μg of fludrocortisone per day (or equivalent).

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (6)

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

NOT YET RECRUITING

Brown University

Providence, Rhode Island, 02903, United States

RECRUITING

Oncopole Claudius Regaud

Toulouse, 31100, France

RECRUITING

Centre Oscar Lambret

Villejuif, 94800, France

NOT YET RECRUITING

Royal Marsden

London, SW3 6JJ, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Adrenocortical Carcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

908-992-6400; CTRinfo_us@daiichisankyo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

FR (2); GB (1); US (3)