Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT06730750Sponsor: Bristol-Myers SquibbLast updated: 2025-12-15

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.

Arms & interventions

  • DrugBMS-986490

    Specified dose on specified days.

  • DrugBevacizumab

    Specified dose on specified days.

Outcome measures

Primary

  • Number of participnats with Adverse Events (AEs)

    Time frame: 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

  • 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

  • Number of participants with AEs leading to discontinuation

    Time frame: Up to 100 days following discontinuation of dosing

  • Number of deaths

    Time frame: Up to 100 days following discontinuation of dosing

Secondary

  • 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)

  • Trough observed concentration (Ctrough)

    Time frame: 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)

  • Time of maximum observed concentration (Tmax)

    Time frame: 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)

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (4)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting
Heinz-Josef Lenz, Site 0007 · Contact

START Midwest

Grand Rapids, Michigan, 49546

Recruiting
Nehal Lakhani, Site 0017 · Contact

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting
Martin Gutierrez, Site 0004 · Contact

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting
Anwaar Saeed, Site 0006 · Contact
A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors | Cancerify