High-grade Serous Ovarian Carcinoma (HGSOC)Phase 1NCT06476808
A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.
A Phase 1 study testing BMS-986463 in people with High-grade Serous Ovarian Carcinoma (HGSOC) and Uterine Serous Carcinoma (USC), run by Bristol-Myers Squibb at 17 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-grade Serous Ovarian Carcinoma (HGSOC), Uterine Serous Carcinoma (USC), Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- BMS-986463
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 6 Sep 2024to 19 Dec 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained.
- Participants must have an unresectable/metastatic carcinoma.
Who cannot join
- Participants must not have Leptomeningeal metastases.
- Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
- Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
17 sites in 5 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
17 sites in 5 countries
United States6 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0045
Columbus, Ohio, 43210
Site 0045
- Withdrawn
Local Institution - 0046
Dallas, Texas, 75390
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Martin Gutierrez, Site 0001, 551-996-5863
- Not yet recruiting
Local Institution - 0049
Houston, Texas, 77054
Site 0049
- Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Anastasia Martynova, Site 0003, 310-226-2905
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
David Berz, Site 0006, 424-535-1874
Canada4 sites, 4 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
Diane Provencher, Site 0028, 514 890-8000
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Susie Lau, Site 0024, 5143408222ext23114
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Amit Oza, Site 0027, 416-946-2818
- Recruiting
BC Cancer Vancouver
Vancouver, British Columbia, V5Z 4E6
Yvette Drew, Site 0026, 604-877-6000
France3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0036
Bordeaux, Aquitaine, 33076
Site 0036
- Not yet recruiting
Local Institution - 0035
Lyon, 69373
Site 0035
- Not yet recruiting
Local Institution - 0031
Villejuif, Val-de-Marne, 94800
Site 0031
Italy2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0033
Milan, 20141
Site 0033
- Not yet recruiting
Local Institution - 0032
Milan, 20159
Site 0032
Spain2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0041
Avda.Pio XII 36,, 31008
Site 0041
- Not yet recruiting
Local Institution - 0042
Barcelona, Barcelona [Barcelona], 08035
Site 0042
About this study
Official title: A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors
The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.
- Conditions
- High-grade Serous Ovarian Carcinoma (HGSOC), Uterine Serous Carcinoma (USC), Non-small Cell Lung Cancer (NSCLC)
- Being tested
- BMS-986463
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986463Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Dose Escalation | Experimental | Not described Receives: Drug: BMS-986463 |
| Arm 2: Dose Expansion | Experimental | Not described Receives: Drug: BMS-986463 |
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 108 weeks
Number of participants with serious adverse events (SAEs)
Measured: Up to 108 weeks
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Measured: Up to 108 weeks
Number of participants with AEs leading to discontinuation
Measured: Up to 108 weeks
Number of participants with AEs leading to death
Measured: Up to 108 weeks
Secondary outcomes (6)
Maximum observed concentration (Cmax)
Measured: Up to 104 weeks
Area under the concentration-time curve (AUC)
Measured: Up to 104 weeks
Time of maximum observed concentration (Tmax)
Measured: Up to 104 weeks
Objective response rate (ORR)
Measured: Up to 104 weeks
Disease control rate (DCR)
Measured: Up to 104 weeks
Duration of response (DOR)
Measured: Up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start6 Sep 2024
- Primary completion19 Dec 2028 (estimated)
- Study completion19 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Serous Ovarian Carcinoma (HGSOC)Studies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 240 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
- NCT06476808
- Sponsor's protocol ID
- CA231-0000
- Other IDs
- 2025-523067-38, 2025
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2024
- Last updated
- 20 Jul 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT06476808
- Acronym / sponsor ID
- CA231-0000
- Conditions
- High-grade Serous Ovarian Carcinoma (HGSOC), Uterine Serous Carcinoma (USC), Non-small Cell Lung Cancer (NSCLC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 19 Dec 2028 (estimated)
- Study completion
- 19 Dec 2028 (estimated)
- First posted
- 26 Jun 2024 (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 evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Dose Escalation | Experimental | Drug: BMS-986463 |
| Arm 2: Dose Expansion | Experimental | Drug: BMS-986463 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained.
- Participants must have an unresectable/metastatic carcinoma.
Key exclusion criteria (4 listed)
- Participants must not have Leptomeningeal metastases.
- Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
- Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment.
- 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-986463Specified dose on specified days | Drug | Arm 1: Dose Escalation, Arm 2: Dose Expansion |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 108 weeks
Number of participants with serious adverse events (SAEs)
Time frame: Up to 108 weeks
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Time frame: Up to 108 weeks
Number of participants with AEs leading to discontinuation
Time frame: Up to 108 weeks
Number of participants with AEs leading to death
Time frame: Up to 108 weeks
6 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Up to 104 weeks
Area under the concentration-time curve (AUC)
Time frame: Up to 104 weeks
Time of maximum observed concentration (Tmax)
Time frame: Up to 104 weeks
Objective response rate (ORR)
Time frame: Up to 104 weeks
Disease control rate (DCR)
Time frame: Up to 104 weeks
Duration of response (DOR)
Time frame: Up to 104 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 20 Jul 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
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986463 in people with High-grade Serous Ovarian Carcinoma (HGSOC) and Uterine Serous Carcinoma (USC), run by Bristol-Myers Squibb at 17 sites in 5 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 3 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada, France, Italy, Spain. 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 108 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 20 Jul 2026.