A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

NCT06618287
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
416
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Lead sponsor
Bristol-Myers Squibb
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Start date
2025-02-04
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Number of sites
66
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Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.
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Short title
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
clinicaltrials.gov
Official title
A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations 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
2031-02-26
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First posted
2024-10-01
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Registry last updated
2026-08-18
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Primary completion date
2031-02-26
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Start date
2025-02-04
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Participants
416
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Participant count basis
Estimated
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Planned participants
416
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Protocol amendments
3
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Number of sites
66
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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
NCT06618287
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ClinicalTrials.gov ID
NCT06618287
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Registry record
Open registry record
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Allocation
Randomised
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of participants with adverse events (AEs)

    Timeframe: Up to 3 years

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

    Timeframe: Up to 3 years

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

    Timeframe: Up to 3 years

  4. Number of participants with AEs leading to discontinuation

    Timeframe: Up to 3 years

  5. Number of participants with AEs leading to death

    Timeframe: Up to 3 years

  6. Number of DLTs that occur during the DLT evaluation period

    Timeframe: Up to 3 weeks

  1. Maximum observed serum concentration (Cmax)

    Timeframe: Up to 3 years

  2. Time of maximum observed concentration (Tmax)

    Timeframe: Up to 3 years

  3. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Timeframe: Up to 3 years

  4. Area under the serum concentration-time curve within a dosing interval (AUC(TAU))

    Timeframe: Up to 3 years

  5. Objective response rate (ORR)

    Timeframe: Up to 2 year

Sources for outcomes
clinicaltrials.gov

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

  • Participants must have at least one measurable lesion per response evaluation criteria in solid tumors.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Participants must have a life expectancy of at least 3 months at the time of the first dose.
  • Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed
  • Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC.
  • Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC.
  • Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO/CAP criteria, based on the most recently analyzed biopsy or another pathology specimen.
  • Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent.

  • Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology.
  • Participants with known mutations in EGFR will be excluded (Group A,B and E).
  • Participants must not have a history of serious recurrent infections.
  • Participants must not have a history of severe heart disease.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Sources for eligibility
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  • University of Alabama at BirminghamBirmingham, United StatesRecruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer CenterMiami, United StatesRecruiting
  • Local Institution - 0065Iowa City, United StatesNot yet recruiting
  • Local Institution - 0140St Louis, United StatesNot yet recruiting
  • John Theurer Cancer Center at Hackensack University Medical CenterHackensack, United StatesRecruiting
  • Cleveland ClinicCleveland, United StatesRecruiting
  • Local Institution - 0102Columbus, United StatesNot yet recruiting
  • Providence Portland Medical CenterPortland, United StatesRecruiting
  • Providence St. Vincent Medical CenterPortland, United StatesRecruiting
  • Local Institution - 0052Portland, United StatesNot yet recruiting
  • Local Institution - 0014Pittsburgh, United StatesWithdrawn
  • University of Tennessee Medical CenterKnoxville, United StatesRecruiting
  • NEXT Oncology - IrvingIrving, United StatesRecruiting
  • Swedish Medical CenterSeattle, United StatesRecruiting
  • Liverpool HospitalLiverpool, AustraliaRecruiting
  • Princess Alexandra HospitalWoolloongabba, AustraliaRecruiting
  • Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting
  • Local Institution - 0101Subiaco, AustraliaNot yet recruiting
  • Cross Cancer InstituteEdmonton, CanadaRecruiting
  • Local Institution - 0064Newmarket, CanadaNot yet recruiting
  • Local Institution - 0023Ottawa, CanadaWithdrawn
  • The Ottawa Hospital - General CampusOttawa, CanadaRecruiting
  • Centre Hospitalier de l'Université de MontréalMontreal, CanadaRecruiting
  • Jewish General HospitalMontreal, CanadaRecruiting
  • Local Institution - 0144Montreal, CanadaNot yet recruiting

And 41 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1308-2752
  • 2024-514947-27
Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Conditions (6)

Targets (2)