DS9051b for advanced or metastatic adrenocortical carcinoma and metastatic castration‑resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, first‑in‑human dose‑escalation trial of DS9051b enrolling adults with histologically confirmed advanced or metastatic adrenocortical carcinoma (ACC) or metastatic castration‑resistant prostate cancer (mCRPC). The dose escalation portion seeks to define the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) while characterizing safety, tolerability, and pharmacokinetics. Investigators will monitor preliminary efficacy signals with tumor response assessments and relevant biomarkers. Participants must meet performance status and organ function criteria and, for mCRPC, have prior AR pathway inhibitor exposure.

Why it matters

Who can join: the full rules

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.

Where it's running

• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting
• Brown University
  Providence, Rhode Island, United States Recruiting
• Oncopole Claudius Regaud
  Toulouse, France Recruiting
• Centre Oscar Lambret
  Villejuif, France Not yet recruiting
• Royal Marsden
  London, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: Daiichi Sankyo Contact for Clinical Trial Information
• Email: CTRinfo_us@daiichisankyo.com
• Phone: 908-992-6400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.