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
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- Withdrawn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