A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors

NCT06544655
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
213
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Lead sponsor
Bristol-Myers Squibb
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Start date
2024-10-10
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Number of sites
9
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Summary
The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).
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Short title
A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
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Official title
A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies
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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
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-10-14
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First posted
2024-08-09
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Registry last updated
2026-04-17
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Primary completion date
2027-10-14
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Start date
2024-10-10
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Participants
213
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Participant count basis
Estimated
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Planned participants
213
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Protocol amendments
1
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Number of sites
9
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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
NCT06544655
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ClinicalTrials.gov ID
NCT06544655
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Incidence of adverse events (AEs)

    Timeframe: Up to approximately 2 years

  2. Incidence of serious adverse events (SAEs)

    Timeframe: Up to approximately 2 years

  3. Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

    Timeframe: Up to approximately 28 days

  4. Incidence of AEs leading to discontinuation

    Timeframe: Up to approximately 2 years

  5. Incidence of AEs leading to death

    Timeframe: Up to approximately 2 years

  1. Maximum observed concentration (Cmax)

    Timeframe: Up to approximately 2 years

  2. Time of maximum observed concentration (Tmax)

    Timeframe: Up to approximately 2 years

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

    Timeframe: Up to approximately 2 years

  4. Incidence of anti-drug antibodies (ADAs)

    Timeframe: Up to approximately 2 years

  5. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Timeframe: Up to approximately 2 years

  6. Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Timeframe: Up to approximately 2 years

  7. Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Timeframe: Up to approximately 2 years

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

  • Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN).
  • Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
  • Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

  • History of or with active interstitial lung disease or pulmonary fibrosis.
  • Active, known, or suspected autoimmune disease.
  • Serious uncontrolled medical disorders.
  • New onset, non-catheter-associated venous thromboembolism within the past 6 months.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Sources for eligibility
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  • Local Institution - 0003Tucson, United States
  • Local Institution - 0007Los Angeles, United States
  • Local Institution - 0011Grand Rapids, United States
  • Local Institution - 0004Sioux Falls, United States
  • Local Institution - 0013San Antonio, United States
  • Local Institution - 0021Darlinghurst, Australia
  • Local Institution - 0019Elizabeth Vale, Australia
  • Local Institution - 0017Toronto, Canada
  • Local Institution - 0016Montreal, Canada
Sources for sites
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Sources for references
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Related records

Drugs (5)

Lead sponsors (1)

Conditions (3)

Targets (2)