Metastatic Castration-resistant Prostate CancerPhase 1NCT06067841
A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
A Phase 1 study testing BMS-986460 in people with Metastatic Castration-resistant Prostate Cancer, run by Bristol-Myers Squibb at 15 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with 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
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- BMS-986460
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 18 Oct 2023to 27 Jul 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL at Screening
- Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)
Who cannot join
- Participant must not have history of brain metastases.
- Participant must not have impaired cardiac function or clinically significant cardiac disease.
- Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
15 sites in 3 countries
United States8 sites, 7 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Atish Choudhury, Site 0003, 000-000-0000
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Andrew Armstrong, Site 0001, 919-668-8797
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Dana Rathkopf, Site 0002, 646-422-4379
- Recruiting
Stanford Cancer Center
Palo Alto, California, 94304
Sandhya Srinivas, Site 0004, 650-725-2078
- Withdrawn
Local Institution - 0006
San Antonio, Texas, 78229
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
David Sommerhalder, Site 0008, 210-580-9500
- Recruiting
Florida Cancer Specialists Sarasota Drug Development Unit
Sarasota, Florida, 34232
Manish Patel, Site 0007, 941-377-9993
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Ruben Raychaudhuri, Site 0005, 206-618-8002
France5 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0018
Bordeaux, Aquitaine, 33076
Site 0018
- Recruiting
Centre Leon Berard
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373
Armelle Vinceneux, Site 0013, 33426556833
- Recruiting
Institut Paoli-Calmettes
Marseille, Nan, 13009
Gwenaelle Gravis, Site 0019, 33491223894
- Not yet recruiting
Local Institution - 0017
Paris, 75015
Site 0017
- Recruiting
Gustave Roussy
Villejuif, Val-de-Marne, 94800
Christophe Massard, Site 0014, +33142114211
Canada2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0011
Montreal, Quebec, H2X 0A9
Site 0011
- Not yet recruiting
Local Institution - 0009
Toronto, Ontario, M5G 2M9
Site 0009
About this study
Official title: A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate Cancer.
- Being tested
- BMS-986460
- Keywords
- Prostate Cancer, 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.
BMS-986460Drug
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Administration of BMS-986460 | Experimental | Not described Receives: Drug: BMS-986460 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to 112 weeks
Number of participants with serious adverse events (SAEs)
Measured: Up to 112 weeks
Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
Measured: Up to 28 days
Number of participants with AEs leading to study intervention discontinuation
Measured: Up to 104 weeks
Number of deaths
Measured: Up to 108 weeks
Secondary outcomes (6)
Maximum concentration (Cmax)
Measured: Up to 13 weeks
Time of maximum concentration (Tmax)
Measured: Up to 13 weeks
Area under the plasma concentration-time curve (AUC)
Measured: Up to 13 weeks
Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate
Measured: Up to 108 weeks
Number of participants with soft tissue response
Measured: Up to 108 weeks
Duration of response (DOR)
Measured: Up to 108 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start18 Oct 2023
- Primary completion24 Aug 2029 (estimated)
- Study completion27 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- 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
- NCT06067841
- Sponsor's protocol ID
- CA125-1008
- Other IDs
- 2024-513987-24, U1111-1307-2450
- Status last verified
- Aug 2026
- First submitted
- 28 Sep 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06067841
- Acronym / sponsor ID
- CA125-1008
- Keywords
- Prostate Cancer, Castration-resistant prostate cancer, Adenocarcinoma of the prostate, Prostatic Neoplasms Castration-Resistant, Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 24 Aug 2029 (estimated)
- Study completion
- 27 Jul 2031 (estimated)
- First posted
- 5 Oct 2023 (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 BMS-986460 in men with 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 BMS-986460 | Experimental | Drug: BMS-986460 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL at Screening
- Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)
Key exclusion criteria (4 listed)
- Participant must not have history of brain metastases.
- Participant must not have impaired cardiac function or clinically significant cardiac disease.
- Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment.
- 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 |
|---|---|---|
| BMS-986460Specified dose on specified days. | Drug | Administration of BMS-986460 |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 112 weeks
Number of participants with serious adverse events (SAEs)
Time frame: Up to 112 weeks
Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
Time frame: Up to 28 days
Number of participants with AEs leading to study intervention discontinuation
Time frame: Up to 104 weeks
Number of deaths
Time frame: Up to 108 weeks
6 secondary outcomes
Maximum concentration (Cmax)
Time frame: Up to 13 weeks
Time of maximum concentration (Tmax)
Time frame: Up to 13 weeks
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 13 weeks
Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate
Time frame: Up to 108 weeks
Number of participants with soft tissue response
Time frame: Up to 108 weeks
Duration of response (DOR)
Time frame: Up to 108 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986460 in people with Metastatic Castration-resistant Prostate Cancer, run by Bristol-Myers Squibb at 15 sites in 3 countries.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, France, Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Up to 112 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.