Recruiting
Phase 1

DS9051b

Sponsor:

Daiichi Sankyo

Code:

NCT07189403

Conditions

Advanced or Metastatic Adrenocortical Carcinoma

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DS9051b

Study Details

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

Advanced or Metastatic Adrenocortical Carcinoma

Metastatic Castration-resistant Prostate Cancer

Study ID

NCT07189403

Start date

Nov 4, 2025

Status verified date

May, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

General Inclusion Criteria for All Participants

1. Sign and date the main ICF, prior to the start of any trial-specific procedures.
2. 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)
3. Histologically confirmed diagnosis of ACC or adenocarcinoma of the prostate
4. 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)
5. 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.

Additional Inclusion Criteria for Participants with mCRPC
6. 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).
7. Treatment with at least 1 line (or more) of chemotherapy, having ineligibility for chemotherapy or refusal of chemotherapy.
8. 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:

1. History of pituitary gland dysfunction.
2. Active or uncontrolled autoimmune disease requiring systemic treatment.
3. 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).
4. Active infection or other medical conditions that would make corticosteroids contraindicated.
5. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated, clinically progressive, symptomatic, or requiring systemic therapy with corticosteroids or anticonvulsants or local therapy (ie, radiotherapy) to control associated symptoms.
6. Uncontrolled or significant cardiovascular disease.
7. History of another primary malignancy (beyond the indication\[s\] under study) except for:

  • Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of trial intervention and of low potential risk for recurrence.
  • Non-melanoma skin cancer, lentigo maligna, or lentigo maligna melanoma treated with curative intent and without evidence of disease.
  • Carcinoma in situ treated with curative intent and without evidence of disease.
  • Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who, in the opinion of the investigator, are not deemed to require active intervention.
8. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, Grade ≤1 or baseline.
9. Participants who cannot swallow whole DS9051b tablets and/or follow DS9051b administration schedule at protocol-defined frequency due to some reasons (eg, dysphagia etc).
10. Known gastrointestinal disease or gastrointestinal procedure that may interfere with absorption of trial intervention including proton pump inhibitors and antacids.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DS9051b

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

Interventions

DS9051b

Administered orally

Primary outcome measure

  • 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 [ Time Frame: Baseline up to 50 months ]

Central Contacts and Locations

Central contacts

Daiichi Sankyo Contact for Clinical Trial Information

908-992-6400CTRinfo_us@daiichisankyo.com

Locations

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Columbia University

Recruiting

New York, New York, United States, 10032

Brown University

Recruiting

Providence, Rhode Island, United States, 02903

More Information

Sponsor

Daiichi Sankyo

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Daiichi Sankyo on 2026-05-22.