A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors

NCT07160725
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
540
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Lead sponsor
Bristol-Myers Squibb
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Start date
2025-10-15
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Number of sites
20
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Summary
A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors
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Short title
A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors
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Official title
A Phase 1/2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2028-08-01
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First posted
2025-09-08
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Registry last updated
2026-08-11
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Primary completion date
2028-07-31
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Start date
2025-10-15
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Participants
540
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Participant count basis
Estimated
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Planned participants
540
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Protocol amendments
1
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Number of sites
20
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Bristol-Myers Squibb
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07160725
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ClinicalTrials.gov ID
NCT07160725
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of Participants with Adverse Events (AE)

    Timeframe: Up to approximately 2 years

  2. Number of Participants with Serious Adverse Events (SAE)

    Timeframe: Up to approximately 2 years

  3. Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria

    Timeframe: Up to Day 21

    For part 1 only

  4. Number of Participants with AEs Leading to Discontinuation

    Timeframe: Up to approximately 2 years

  5. Number of Participants with AEs Leading to Deaths

    Timeframe: Up to approximately 2 years

  1. Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment

    Timeframe: Up to approximately 3 years

  2. Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment

    Timeframe: Up to approximately 3 years

  3. Maximum Plasma Concentration (Cmax)

    Timeframe: Up to approximately 2 years

  4. Time to Reach Maximum Plasma Concentration (Tmax)

    Timeframe: Up to approximately 2 years

  5. Area Under Curve (AUC)

    Timeframe: Up to approximately 2 years

  6. Total anti-drug antibodies (ADAs)

    Timeframe: Up to approximately 2 Years

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Participants must have an ECOG performance status of 0 to 1.
  • Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator).
  • Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer.

  • Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
  • Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
  • Participants must not have history of serious recurrent infections.
  • Participants must not have impaired cardiac function or history of severe heart disease.
  • For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy.
  • For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis.
  • For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Sources for eligibility
clinicaltrials.gov

  • Local Institution - 0033Irvine, United StatesNot yet recruiting
  • USC/Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting
  • University of California, Irvine (UCI) Health - UC Irvine Medical CenterOrange, United StatesRecruiting
  • UPMC Hillman Cancer CenterPittsburgh, United StatesRecruiting
  • Sanford Cancer CenterSioux Falls, United StatesRecruiting
  • START - Dallas Fort WorthFort Worth, United StatesRecruiting
  • START San AntonioSan Antonio, United StatesRecruiting
  • START Mountain RegionWest Valley City, United StatesRecruiting
  • Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting
  • Local Institution - 0034Guangzhou, ChinaNot yet recruiting
  • Herlev and Gentofte HospitalCopenhagen, DenmarkRecruiting
  • Odense UniversitetshospitalOdense, DenmarkRecruiting
  • Copenhagen University Hospital RigshospitaletCopenhagen, DenmarkRecruiting
  • National Cancer Center HospitalChuo-ku, JapanRecruiting
  • Local Institution - 0026Málaga, SpainNot yet recruiting
  • Local Institution - 0022Badalona, SpainNot yet recruiting
  • Local Institution - 0024Barcelona, SpainNot yet recruiting
  • Clinica Universidad de NavarraPamplona, SpainRecruiting
  • Hospital Universitario Fundación Jiménez DíazMadrid, SpainRecruiting
  • Local Institution - 0023Madrid, SpainNot yet recruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • WHO
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)