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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Daiichi Sankyo
Study ID
NCT07189403
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DS9051b — DRUG
    Administered orally

Study Details

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

Key Dates

Start date
Nov 4, 2025
Status verified
May 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

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

Locations (3)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsSarasotaFlorida34232
Principal Investigator
Columbia UniversityNew YorkNew York10032
Principal Investigator
Brown UniversityProvidenceRhode Island02903
Principal Investigator

Find similar trials in Sarasota, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Florida Cancer Specialists· Sarasota, FLColumbia University· New York, NYBrown University· Providence, RI

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