Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer

Celgene

Status and phase: Active, not recruiting; Phase 1

Conditions: Prostatic Neoplasms

Treatments: Drug: CC1083611; Drug: CC1083610; Drug: CC-94676

Study type: Interventional

Funder types: Industry

Identifiers

NCT04428788

CC-94676-PCA-001

U1111-1251-9174 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Administration of CC-94676, CC1083611, and CC1083610

Experimental group

Treatment:

Drug: CC-94676

Drug: CC1083610

Drug: CC1083611