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NCT Number: NCT06730750

A 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986490

Drug

Specified dose on specified days.

Bevacizumab

Drug

Specified dose on specified days.

Primary outcomes

  1. Number of participnats with Adverse Events (AEs)

    Time frame: Up to 100 days following discontinuation of dosing

  2. Number of participants with Serious AEs (SAEs)

    Time frame: Up to 100 days following discontinuation of dosing

  3. 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

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to 100 days following discontinuation of dosing

  5. Number of deaths

    Time frame: Up to 100 days following discontinuation of dosing

Secondary outcomes

  1. 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)

  2. Trough observed concentration (Ctrough)

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

  3. Maximum observed concentration (Cmax)

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

  4. Time of maximum observed concentration (Tmax)

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

  5. Total anti-drug antibodies (ADAs)

    Time frame: 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

    Time frame: Up to approximately 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Dec 12, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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