A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors

NCT06730750
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
360
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Lead sponsor
Bristol-Myers Squibb
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Start date
2025-02-12
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Number of sites
6
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Summary
This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.
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Short title
A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
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Official title
A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in 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
2029-12-09
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First posted
2024-12-12
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Registry last updated
2026-07-02
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Primary completion date
2026-09-05
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Start date
2025-02-12
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Participants
360
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Participant count basis
Estimated
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Planned participants
360
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Protocol amendments
1
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Number of sites
6
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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
NCT06730750
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ClinicalTrials.gov ID
NCT06730750
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of participnats with Adverse Events (AEs)

    Timeframe: Up to 100 days following discontinuation of dosing

  2. Number of participants with Serious AEs (SAEs)

    Timeframe: Up to 100 days following discontinuation of dosing

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

    Timeframe: Up to 28 days after the first treatment of study intervention

  4. Number of participants with AEs leading to discontinuation

    Timeframe: Up to 100 days following discontinuation of dosing

  5. Number of deaths

    Timeframe: Up to 100 days following discontinuation of dosing

  1. Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

    Timeframe: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)

  2. Trough observed concentration (Ctrough)

    Timeframe: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)

  3. Maximum observed concentration (Cmax)

    Timeframe: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)

  4. Time of maximum observed concentration (Tmax)

    Timeframe: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)

  5. Total anti-drug antibodies (ADAs)

    Timeframe: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)

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

    Timeframe: Up to approximately 4 years

Sources for outcomes
clinicaltrials.gov

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

  • Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.1.

  • CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:

    i) Locally advanced/metastatic, recurrent, or unresectable CRC with adenocarcinoma histology and whose disease has progressed after systemic cancer therapy in the metastatic or adjuvant setting including 5-FU, irinotecan, and/or oxaliplatin (if available and not contraindicated).

  • NSCLC: Part 2A-NSCLC/GC, 2L+ NSCLC:

    i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.

ii) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.

- GC: Part 2A-NSCLC/GC, 2L+ GC: i) Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy).

ii) ECOG performance status of 0 or 1.

  • History of anaphylactic reactions to irinotecan and/or bevacizumab.
  • Previously received therapy targeting CEACAM5.
  • Grade ≥3 ILD/pneumonitis.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Sources for eligibility
clinicaltrials.gov

  • Local Institution - 0007Los Angeles, United StatesActive, not recruiting
  • Local Institution - 0017Grand Rapids, United StatesActive, not recruiting
  • Local Institution - 0004Hackensack, United StatesActive, not recruiting
  • Local Institution - 0006Pittsburgh, United StatesActive, not recruiting
  • Tasman Oncology ResearchSouthport, AustraliaRecruiting
  • Princess Margaret Cancer CentreToronto, CanadaRecruiting
Sources for sites
clinicaltrials.gov

  • U1111-1313-7004
  • 2024-518421-14
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)

Targets (1)