A Phase 1, Multi-Center, Open-Label, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics cf CC-94676 In Subjects with Metastatic Castration-Resistant Prostate Cancer

Protocol # :
Prostatic Neoplasms
Disease Sites
Principal Investigator
Choudhury, Atish
Site Research Nurses
Aspinwall, Sheridan
Bretta, Katherine, v.
Carey, Margaret, M.
Healy, Erin, C.
Katica, Dean
Lagerstedt, Elizabeth
Leisner, Claire
Mingrino, Sage
Pace, Amanda
Porter, Kathryn
Prisby, Judith
Walsh, Meghara

Trial Description

The purpose of this study is to assess the safety, tolerability and preliminary efficacy of
CC-94676 in men with progressive metastatic castration resistant prostate cancer.

Eligibility Requirements

Inclusion Criteria:

- Must have histologically or cytologically confirmed adenocarcinoma of the prostate

- Progressed on androgen deprivation therapy (ADT) and at least one prior secondary
hormonal therapy approved for castration-resistant prostate cancer (CRPC)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

- Prior treatment with an androgen receptor (AR) degrader

- Concurrent malignancy (present during screening) requiring treatment or history of
prior malignancy active within 1 year prior to the first dose of IP

- Clinically significant venous thromboembolism within 3 months prior to the first dose
of IP

- Any significant medical condition, such as uncontrolled infection, laboratory
abnormality, or psychiatric illness

Other protocol-defined inclusion/exclusion criteria apply