CClinicalTrials.gg
RecruitingNCT06476808Updated Jul 20, 2026

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 interventional study of BMS-986463 in High-grade Serous Ovarian Carcinoma (HGSOC), Uterine Serous Carcinoma (USC) and Non-small Cell Lung Cancer (NSCLC), sponsored by Bristol-Myers Squibb. Recruiting at 17 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Phase 1
Study type
Interventional
Enrollment
240
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • High-grade Serous Ovarian Carcinoma (HGSOC)
  • Uterine Serous Carcinoma (USC)
  • Non-small Cell Lung Cancer (NSCLC)
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 240 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Arm 1: Dose Escalation

    Drug: BMS-986463

  • Experimental
    Arm 2: Dose Expansion

    Drug: BMS-986463

Interventions

  • DrugBMS-986463

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 108 weeks

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 108 weeks

  3. Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

    Time frame: Up to 108 weeks

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to 108 weeks

  5. Number of participants with AEs leading to death

    Time frame: Up to 108 weeks

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to 104 weeks

  2. Area under the concentration-time curve (AUC)

    Time frame: Up to 104 weeks

  3. Time of maximum observed concentration (Tmax)

    Time frame: Up to 104 weeks

  4. Objective response rate (ORR)

    Time frame: Up to 104 weeks

  5. Disease control rate (DCR)

    Time frame: Up to 104 weeks

  6. Duration of response (DOR)

    Time frame: Up to 104 weeks

07

Study locations

7 of 17 sites recruiting
  • USC/Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
    • Anastasia Martynova, Site 0003 · Contact · 310-226-2905
    Recruiting
  • Valkyrie Clinical Trials
    Los Angeles, California 90067, United States
    • David Berz, Site 0006 · Contact · 424-535-1874
    Recruiting
  • John Theurer Cancer Center at Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
    • Martin Gutierrez, Site 0001 · Contact · 551-996-5863
    Recruiting
  • Local Institution - 0045
    Columbus, Ohio 43210, United States
    • Site 0045 · Contact
    Not yet recruiting
  • Local Institution - 0046
    Dallas, Texas 75390, United States
    Withdrawn
  • Local Institution - 0049
    Houston, Texas 77054, United States
    • Site 0049 · Contact
    Not yet recruiting
  • BC Cancer Vancouver
    Vancouver, British Columbia V5Z 4E6, Canada
    • Yvette Drew, Site 0026 · Contact · 604-877-6000
    Recruiting
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
    • Amit Oza, Site 0027 · Contact · 416-946-2818
    Recruiting
  • Centre Hospitalier de l'Université de Montréal
    Montreal, Quebec H2X 3E4, Canada
    • Diane Provencher, Site 0028 · Contact · 514 890-8000
    Recruiting
  • Jewish General Hospital
    Montreal, Quebec H3T 1E2, Canada
    • Susie Lau, Site 0024 · Contact · 5143408222ext23114
    Recruiting
  • Local Institution - 0036
    Bordeaux, Aquitaine 33076, France
    • Site 0036 · Contact
    Not yet recruiting
  • Local Institution - 0031
    Villejuif, Val-de-Marne 94800, France
    • Site 0031 · Contact
    Not yet recruiting
  • Local Institution - 0035
    Lyon, 69373, France
    • Site 0035 · Contact
    Not yet recruiting
  • Local Institution - 0033
    Milan, 20141, Italy
    • Site 0033 · Contact
    Not yet recruiting
  • Local Institution - 0032
    Milan, 20159, Italy
    • Site 0032 · Contact
    Not yet recruiting
  • Local Institution - 0042
    Barcelona, Barcelona [Barcelona] 08035, Spain
    • Site 0042 · Contact
    Not yet recruiting
  • Local Institution - 0041
    Avda.Pio XII 36,, 31008, Spain
    • Site 0041 · Contact
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06476808
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jun 26, 2024
Start date
Sep 6, 2024
Primary completion
Dec 19, 2028 (estimated)
Completion
Dec 19, 2028 (estimated)
Last update
Jul 20, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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