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

A Phase 1, Multi-center, Open-label, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cc-94676 in Subjects With Metastatic Castration-resistant Prostate Cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04428788
Enrollment
131
Registered
2020-06-11
Start date
2020-06-22
Completion date
2025-10-28
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

Prostate Cancer, CC-94676, Castration-resistant prostate cancer, Adenocarcinoma of the prostate, Prostatic Neoplasms Castration-Resistant, Neoplasms

Brief summary

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.

Interventions

DRUGCC1083611

Specified dose on specified days

DRUGCC1083610

Specified dose on specified days

DRUGCC-94676

Specified dose on specified days

Sponsors

Celgene
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteriaFrom the time of consent at screening until 28 days after thesubject discontinues study treatment.
Dose-limiting toxicity (DLT)Up to 35 days
Non-tolerated dose (NTD)Up to 35 days
Maximum tolerated dose (MTD)Up to 35 days

Secondary

MeasureTime frame
Duration of response (DOR)Up to approximately 4 years
Proportion of participants alive and not progressed at 6 monthsUp to 6 months after treatment is discontinued
PSA Progression Free Survival (PFS)Up to approximately 4 years
Pharmacokinetics - Maximum plasma concentration (Cmax)Up to 35 days
Overall survival (OS)Up to approximately 4 years
Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated populationUp to approximately 4 years
Pharmacokinetics - Area under the plasma concentration time curve (AUC)Up to 35 days
Radiographic progression free survival (rPFS)Up to approximately 4 years
Pharmacokinetics - Time to Cmax (Tmax)Up to 35 days
Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)Up to approximately 4 years
Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)Up to approximately 4 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026