A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

NCT06997029
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
234
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Lead sponsor
Bristol-Myers Squibb
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Start date
2025-08-01
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Number of sites
21
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Summary
The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.
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Short title
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
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Official title
A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer
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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
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Study type
Interventional
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Completion date
2028-12-14
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First posted
2025-05-30
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Registry last updated
2026-07-10
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Primary completion date
2028-12-14
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Start date
2025-08-01
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Participants
234
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Participant count basis
Estimated
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Planned participants
234
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Protocol amendments
1
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Number of sites
21
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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
NCT06997029
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ClinicalTrials.gov ID
NCT06997029
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Participants With Dose Limiting Toxicities (DLTs)

    Timeframe: Up to Day 28 From Last Dose

  2. Number of Participants With Adverse Events (AEs)

    Timeframe: Up to Day 28 From Last Dose

  3. Number of Participants With Serious Adverse Events (SAEs)

    Timeframe: Up to Day 28 From Last Dose

  4. Number of Participants With AEs Leading to Discontinuation

    Timeframe: Up to Day 28 From Last Dose

  5. Number of Participants With TEAEs Leading to Death

    Timeframe: Up to Day 28 From Last Dose

  1. Maximum Observed Serum Concentration (Cmax) of BMS-986500

    Timeframe: Up to Approximately 2 Years

  2. Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500

    Timeframe: Up to Approximately 2 Years

  3. Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500

    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 be ≥ 18 years of age.
  • Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.
  • Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • For Part 2A only, participants must have CCNE1-amplified ovarian cancer

  • Participants must not have an active brain metastasis.
  • Participants must not have impaired cardiac function or clinically significant cardiac disease.
  • Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.
  • Participants must not have Grade ≥ 2 peripheral neuropathy.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Sources for eligibility
clinicaltrials.gov

  • University of Alabama at BirminghamBirmingham, United StatesRecruiting
  • Providence St. Jude Medical CenterFullerton, United StatesRecruiting
  • Marin Cancer CareGreenbrae, United StatesRecruiting
  • Moores Cancer CenterLa Jolla, United StatesRecruiting
  • Hoag Memorial Hospital PresbyterianNewport Beach, United StatesRecruiting
  • Local Institution - 0008Aurora, United StatesNot yet recruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • Washington University School of MedicineSt Louis, United StatesRecruiting
  • Dartmouth-Hitchcock Medical CenterLebanon, United StatesRecruiting
  • Roswell Park Cancer InstituteBuffalo, United StatesRecruiting
  • Northwell Health-Cancer InstituteNew Hyde Park, United StatesRecruiting
  • Local Institution - 0011New York, United StatesNot yet recruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • START Dallas Fort WorthFort Worth, United StatesRecruiting
  • NEXT OncologySan Antonio, United StatesRecruiting
  • Odense UniversitetshospitalOdense, DenmarkRecruiting
  • Copenhagen University HospitalCopenhagen, DenmarkRecruiting
  • National Cancer Center Hospital EastKashiwa, JapanRecruiting
  • Kansai Medical University HospitalHirakata, JapanRecruiting
  • National Cancer Center HospitalChuo-ku, JapanRecruiting
  • The Cancer Institute Hospital of JFCRKoto-ku, JapanRecruiting
Sources for sites
clinicaltrials.gov

  • 2025
  • U1111-1330-3304
  • 2025-524334-26-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (4)