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

August 31, 2026 updated by: Bristol-Myers Squibb

A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Tasman Oncology Research
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0003
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Local Institution - 0007
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Local Institution - 0017
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0004
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1A
Drug: BMS-986490
Specified dose on specified days.
Experimental: Part 2A - Colorectal Cancer (CRC)
Drug: BMS-986490
Specified dose on specified days.
Experimental: Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC)
Drug: BMS-986490
Specified dose on specified days.
Experimental: Part 1B
Drug: BMS-986490
Specified dose on specified days.
Drug: Bevacizumab
Specified dose on specified days.
Experimental: Part 2B
Drug: BMS-986490
Specified dose on specified days.
Drug: Bevacizumab
Specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participnats with Adverse Events (AEs)
Time Frame: Up to 100 days following discontinuation of dosing
Up to 100 days following discontinuation of dosing
Number of participants with Serious AEs (SAEs)
Time Frame: Up to 100 days following discontinuation of dosing
Up to 100 days following discontinuation of dosing
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Time Frame: Up to 28 days after the first treatment of study intervention
Up to 28 days after the first treatment of study intervention
Number of participants with AEs leading to discontinuation
Time Frame: Up to 100 days following discontinuation of dosing
Up to 100 days following discontinuation of dosing
Number of deaths
Time Frame: Up to 100 days following discontinuation of dosing
Up to 100 days following discontinuation of dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time Frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Trough observed concentration (Ctrough)
Time Frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Maximum observed concentration (Cmax)
Time Frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Time of maximum observed concentration (Tmax)
Time Frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Total anti-drug antibodies (ADAs)
Time Frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by Investigator
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2025

Primary Completion (Estimated)

September 5, 2026

Study Completion (Estimated)

December 9, 2029

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 12, 2024

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA238-0001
  • 2024-518421-14 (Other Identifier: EU CTR)
  • U1111-1313-7004 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe