ClinicaliQ Trial Snapshot
- A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer — Recruiting • Phase I • Oncology • NCT07189403.
- Sponsor: Daiichi Sankyo.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.
Eligibility Snapshot
- General Inclusion Criteria for All Participants 1. 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) 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.