A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors

NCT06697197
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
413
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Lead sponsor
Bristol-Myers Squibb
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Start date
2025-02-17
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Number of sites
21
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Summary
The purpose of this study is to test the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.
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Short title
A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors
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Official title
A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in 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
2029-01-05
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First posted
2024-11-20
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Registry last updated
2026-02-03
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Primary completion date
2029-01-04
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Start date
2025-02-17
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Participants
413
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Participant count basis
Estimated
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Planned participants
413
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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
NCT06697197
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ClinicalTrials.gov ID
NCT06697197
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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 (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)

    Timeframe: Up to 135 days post last treatment visit

  2. Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0

    Timeframe: Up to 135 days post last treatment visit

  3. Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria as assessed by NCI-CTCAE v5.0

    Timeframe: Up to Day 28

  4. Number of participants with AEs leading to discontinuation as assessed by NCI-CTCAE v5.0

    Timeframe: Up to 135 days post last treatment visit

  5. Number of deaths as assessed by NCI-CTCAE v5.0

    Timeframe: Through study completion (Up to 4 years)

  1. Concentration at the end of infusion (Cmax)

    Timeframe: Up to 135 days post last treatment visit

  2. Time of maximum observed concentration (Tmax)

    Timeframe: Up to 135 days post last treatment visit

  3. Area under the concentration-time curve in one dosing interval (AUC(TAU))

    Timeframe: Up to 135 days post last treatment visit

  4. Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by Investigator

    Timeframe: Up to 135 days post last treatment visit

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

  • All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
  • Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.

  • History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
  • Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Sources for eligibility
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  • University of California, Irvine (UCI) Health - UC Irvine Medical CenterIrvine, United StatesRecruiting
  • The Angeles Clinic and Research Institute - West Los Angeles OfficeLos Angeles, United StatesRecruiting
  • Local Institution - 0008Aurora, United StatesNot yet recruiting
  • John Theurer Cancer Center at Hackensack University Medical CenterHackensack, United StatesRecruiting
  • Northwell Health/ RJ Zuckerberg Cancer CenterLake Success, United StatesRecruiting
  • Levine Cancer InstituteCharlotte, United StatesRecruiting
  • Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting
  • UZ GentGhent, BelgiumRecruiting
  • RigshospitaletCopenhagen, DenmarkRecruiting
  • Assistance Publique Hôpitaux de Marseille - Hôpital de la TimoneMarseille, FranceRecruiting
  • Gustave RoussyVillejuif, FranceRecruiting
  • General Hospital of Athens "Laiko"Athens, GreeceRecruiting
  • Papageorgiou General Hospital of ThessalonikiThessaloniki, GreeceRecruiting
  • Fondazione IRCCS Istituto Nazionale dei TumoriMilan, ItalyRecruiting
  • Istituto Clinico HumanitasRozzano, ItalyRecruiting
  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)Amsterdam, NetherlandsRecruiting
  • Erasmus Medisch CentrumRotterdam, NetherlandsRecruiting
  • Hospital Universitari Vall d'HebronBarcelona, SpainRecruiting
  • Clinica Universidad de NavarraPamplona, SpainRecruiting
  • Hospital Universitario HM SanchinarroMadrid, SpainRecruiting
  • Karolinska Universitetssjukhuset SolnaSolna, SwedenRecruiting
Sources for sites
clinicaltrials.gov

  • U1111-1309-0886
  • 2024-516602-28
Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Targets (3)