Prostatic NeoplasmsPhase 1NCT04428788
Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study testing CC-94676, CC1083611 and CC1083610 in people with Prostatic Neoplasms, run by Celgene at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- CC-94676, CC1083611 and CC1083610
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 19 sitesUnited States
- Study dates
- 22 Jun 2020to 28 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Local Institution - 120
Allentown, Pennsylvania, 18103
Local Institution - 117
Ann Arbor, Michigan, 48109
Local Institution - 108
Baltimore, Maryland, 21287
Local Institution - 104
Boston, Massachusetts, 02215
Local Institution - 107
Dallas, Texas, 75235
Local Institution - 106
Durham, North Carolina, 27710
Local Institution - 102
Grand Rapids, Michigan, 49546
Local Institution - 119
Houston, Texas, 77030
Local Institution - 111
Madison, Wisconsin, 53792
Local Institution - 112
New York, New York, 10029
Local Institution - 109
New York, New York, 10032
Local Institution - 105
New York, New York, 10065
Local Institution - 113
Philadelphia, Pennsylvania, 19104
Local Institution - 101
San Antonio, Texas, 78229
Local Institution - 103
Sarasota, Florida, 34232
Local Institution - 115
Seattle, Washington, 98109
Local Institution - 116
Stanford, California, 94305-5826
Local Institution - 121
Thomasville, Georgia, 31792
Local Institution - 122
Washington D.C., District of Columbia, 20010
About this study
Official title: 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
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.
- Conditions
- Prostatic Neoplasms
- Being tested
- CC-94676, CC1083611, CC1083610
- Keywords
- Prostate Cancer, CC-94676, Castration-resistant prostate cancer, Adenocarcinoma of the prostate, Prostatic Neoplasms Castration-Resistant, Neoplasms
- Medical subject headings
- Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-94676Drug
Also called BMS-986365
Specified dose on specified days
CC1083611Drug
Also called BMS-986409
Specified dose on specified days
CC1083610Drug
Also called BMS-986410
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Administration of CC-94676, CC1083611, and CC1083610 | Experimental | Not described Receives: Drug: CC-94676; Drug: CC1083611; Drug: CC1083610 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
Measured: From the time of consent at screening until 28 days after thesubject discontinues study treatment.
Dose-limiting toxicity (DLT)
Measured: Up to 35 days
Non-tolerated dose (NTD)
Measured: Up to 35 days
Maximum tolerated dose (MTD)
Measured: Up to 35 days
Secondary outcomes (11)
Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
Measured: 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)
Measured: Up to approximately 4 years
Duration of response (DOR)
Measured: Up to approximately 4 years
Proportion of participants alive and not progressed at 6 months
Measured: Up to 6 months after treatment is discontinued
PSA Progression Free Survival (PFS)
Measured: Up to approximately 4 years
Radiographic progression free survival (rPFS)
Measured: Up to approximately 4 years
Overall survival (OS)
Measured: Up to approximately 4 years
Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population
Measured: Up to approximately 4 years
Pharmacokinetics - Area under the plasma concentration time curve (AUC)
Measured: Up to 35 days
Pharmacokinetics - Maximum plasma concentration (Cmax)
Measured: Up to 35 days
Pharmacokinetics - Time to Cmax (Tmax)
Measured: Up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start22 Jun 2020
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428788
- Sponsor's protocol ID
- CC-94676-PCA-001
- Other IDs
- U1111-1251-9174
- Status last verified
- Dec 2025
- First submitted
- 29 May 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Publications
Rathkopf DE, Patel MR, Choudhury AD, Rasco D, Lakhani N, Hawley JE, Srinivas S, Aparicio A, Narayan V, Runcie KD, Emamekhoo H, Reichert ZR, Nguyen MH, Wells AL, Kandimalla R, Liu C, Suryawanshi S, Han J, Wu J, Arora VK, Pourdehnad M, Armstrong AJ. Safety and clinical activity of BMS-986365 (CC-94676), a dual androgen receptor ligand-directed degrader and antagonist, in heavily pretreated patients with metastatic castration-resistant prostate cancer. Ann Oncol. 2025 Jan;36(1):76-88. doi: 10.1016/j.annonc.2024.09.005. Epub 2024 Sep 16.
PubMed 39293515
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04428788
- Acronym / sponsor ID
- CC-94676-PCA-001
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate Cancer, CC-94676, Castration-resistant prostate cancer, Adenocarcinoma of the prostate, Prostatic Neoplasms Castration-Resistant, Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of CC-94676, CC1083611, and CC1083610 | Experimental | Drug: CC-94676, Drug: CC1083611, Drug: CC1083610 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-94676Also: BMS-986365Specified dose on specified days | Drug | Administration of CC-94676, CC1083611, and CC1083610 |
| CC1083611Also: BMS-986409Specified dose on specified days | Drug | Administration of CC-94676, CC1083611, and CC1083610 |
| CC1083610Also: BMS-986410Specified dose on specified days | Drug | Administration of CC-94676, CC1083611, and CC1083610 |
Primary outcome
Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
Time frame: From the time of consent at screening until 28 days after thesubject discontinues study treatment.
Dose-limiting toxicity (DLT)
Time frame: Up to 35 days
Non-tolerated dose (NTD)
Time frame: Up to 35 days
Maximum tolerated dose (MTD)
Time frame: Up to 35 days
11 secondary outcomes
Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
Time frame: 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)
Time frame: Up to approximately 4 years
Duration of response (DOR)
Time frame: Up to approximately 4 years
Proportion of participants alive and not progressed at 6 months
Time frame: Up to 6 months after treatment is discontinued
PSA Progression Free Survival (PFS)
Time frame: Up to approximately 4 years
Radiographic progression free survival (rPFS)
Time frame: Up to approximately 4 years
Overall survival (OS)
Time frame: Up to approximately 4 years
Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population
Time frame: Up to approximately 4 years
Pharmacokinetics - Area under the plasma concentration time curve (AUC)
Time frame: Up to 35 days
Pharmacokinetics - Maximum plasma concentration (Cmax)
Time frame: Up to 35 days
Pharmacokinetics - Time to Cmax (Tmax)
Time frame: Up to 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 39293515Rathkopf DE, Patel MR, Choudhury AD, Rasco D, Lakhani N, Hawley JE, Srinivas S, Aparicio A, Narayan V, Runcie KD, Emamekhoo H, Reichert ZR, Nguyen MH, Wells AL, Kandimalla R, Liu C, Suryawanshi S, Han J, Wu J, Arora VK, Pourdehnad M, Armstrong AJ. Safety and clinical activity of BMS-986365 (CC-94676), a dual androgen receptor ligand-directed degrader and antagonist, in heavily pretreated patients with metastatic castration-resistant prostate cancer. Ann Oncol. 2025 Jan;36(1):76-88. doi: 10.1016/j.annonc.2024.09.005. Epub 2024 Sep 16.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-94676, CC1083611 and CC1083610 in people with Prostatic Neoplasms, run by Celgene at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria (time frame: From the time of consent at screening until 28 days after thesubject discontinues study treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04428788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.