Cancer Help Guide

Adrenocortical carcinoma · NCT07189403 · 2025-521886-28-00

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

A Phase 1, First-in-human (FIH), Multicenter, Open-label Trial of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma (ACC) and Metastatic Castration-resistant Prostate Cancer (mCRPC)

Status
RECRUITING (ClinicalTrials.gov)EU CTIS reports this trial halted — check with the site before you apply
Phase
PHASE1
Sponsor
Daiichi Sankyo
Registry records
CTGOV NCT07189403 (RECRUITING)
Registry last updated 2026-05-22

Eligibility, line by line

VerdictIn plain words (machine summary)Registry text, verbatimIf unmet
inclusion
inclusion · consent · confidence 0.30
Sign and date the main ICF, prior to the start of any trial-specific procedures."Sign and date the main ICF, prior to the start of any trial-specific procedures."
inclusion
inclusion · age sex · confidence 0.97
Adults ≥18 years of age at the time the ICF is signed"Adults ≥18 years of age at the time the ICF is signed"
inclusion
inclusion · condition · confidence 0.95
Histologically confirmed diagnosis of ACC or adenocarcinoma of the prostate"Histologically confirmed diagnosis of ACC or adenocarcinoma of the prostate"
inclusion
inclusion · performance status · confidence 0.90
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)"ECOG PS of 0 or 1 assessed no more than 14 days prior to C1D1."
inclusion
inclusion · organ function · confidence 0.30
Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to C1D1 as defined below."Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to C1D1"
inclusion
inclusion · prior therapy · confidence 0.95
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 ARPI therapy for CSPC or in CRPC for a minimum of 12 weeks"
inclusion
inclusion · prior therapy · confidence 0.85
Treatment with at least 1 line (or more) of chemotherapy, having ineligibility for chemotherapy or refusal of chemotherapy."Treatment with at least 1 line (or more) of chemotherapy, having ineligibility for chemotherapy or refusal of chemotherapy."
inclusion
inclusion · condition · confidence 0.95
Documented disease progression by one or more of the following criteria: PSA progression (PCWG3), soft tissue progression (RECIST 1.1), or bone disease progression (PCWG3)."Documented disease progression by one or more of the following criteria:"
exclusion
exclusion · comorbidity · confidence 0.95
History of pituitary gland dysfunction."History of pituitary gland dysfunction."
exclusion
exclusion · comorbidity · confidence 0.95
Active or uncontrolled autoimmune disease requiring systemic treatment."Active or uncontrolled autoimmune disease requiring systemic treatment."
exclusion
exclusion · comorbidity · confidence 0.30
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)."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)."
exclusion
exclusion · comorbidity · confidence 0.90
Active infection or other medical conditions that would make corticosteroids contraindicated."Active infection or other medical conditions that would make corticosteroids contraindicated."
exclusion
exclusion · comorbidity · confidence 0.95
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."Has spinal cord compression or clinically active central nervous system metastases"
exclusion
exclusion · comorbidity · confidence 0.95
Uncontrolled or significant cardiovascular disease."Uncontrolled or significant cardiovascular disease."
exclusion
exclusion · comorbidity · confidence 0.90
History of another primary malignancy (beyond the indication[s] under study) except for specified curatively treated malignancies, non-melanoma skin cancer, carcinoma in situ, and low-stage prostate cancer without recurrence."History of another primary malignancy"
exclusion
exclusion · prior therapy · confidence 0.30
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."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."
exclusion
exclusion · logistics · confidence 0.30
Participants who cannot swallow whole DS9051b tablets and/or follow DS9051b administration schedule at protocol-defined frequency due to some reasons (eg, dysphagia etc)."Participants who cannot swallow whole DS9051b tablets and/or follow DS9051b administration schedule at protocol-defined frequency"
exclusion
exclusion · comorbidity · confidence 0.90
Known gastrointestinal disease or gastrointestinal procedure that may interfere with absorption of trial intervention including proton pump inhibitors and antacids."Known gastrointestinal disease or gastrointestinal procedure that may interfere with absorption of trial intervention"

Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.

Full eligibility text as the registry publishes it
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.

Routes in: how this trial is reached and paid for

  • US trials at ordinary hospitals: routine care is billed

    In the US a sponsor funds the study drug and study-specific scans, but the routine care around them is billed to insurance. Without US cover that bill falls on you.

    Cost is documented as the barrier that stops roughly 45 percent of US patients joining trials, before any question of being a non-resident. Eligibility on paper does not make a US site reachable. One email to the study coordinator asking what a non-resident without US insurance would be billed settles it either way.

    Verify with: The study coordinator listed on the registry record

    Ask first; potentially very high

  • UK access: residence, not citizenship

    Being a British citizen does not by itself entitle you to free NHS treatment; entitlement runs on being ordinarily resident in the UK.

    The UK and EU agreed to continue a planned-treatment scheme equivalent to S2 from 1 January 2021, so an S2 issued by an EU insurer is the thing to ask about for a UK trial. Put the question to both your insurer and the trial coordinator, since sponsors sometimes cover trial-related care regardless.

    Verify with: NHS: planned treatment abroad and the S2 route

    Ask both; not free by citizenship

  • Free patient navigation

    myTomorrows (Amsterdam) provides medically trained, multilingual patient navigators who search ClinicalTrials.gov, EU CTIS and ISRCTN and can support a doctor through an expanded-access application. Free to patients and families.

    A navigator keeps searching after any single page stops being current. Use it alongside this site, not instead of your oncologist.

    Verify with: myTomorrows for patients

    0

Sites (6)

France

  • Oncopole Claudius Regaud, Toulouse
  • Centre Oscar Lambret, Villejuif

United Kingdom

  • Royal Marsden, London

United States

  • Florida Cancer Specialists, Sarasota
  • Columbia University, New York
  • Brown University, Providence