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

NCT06730750 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA238-00012024-518421-14U1111-1313-7004
• Study Type: interventional
• Target: 360
• Locations: 3 countries
• Sites: 6

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

Colorectal Cancer (CRC); Non-small Cell Lung cancer (NSCLC); Gastric Cancer (GC)

Outcome Measures

Primary Outcomes (5)

• Number of participnats with Adverse Events (AEs)

  Up to 100 days following discontinuation of dosing

• Number of participants with Serious AEs (SAEs)

  Up to 100 days following discontinuation of dosing

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

  Up to 28 days after the first treatment of study intervention

• Number of participants with AEs leading to discontinuation

  Up to 100 days following discontinuation of dosing

• Number of deaths

  Up to 100 days following discontinuation of dosing

Secondary Outcomes (6)

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

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

• Trough observed concentration (Ctrough)

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

• Maximum observed concentration (Cmax)

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

• Time of maximum observed concentration (Tmax)

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

• Total anti-drug antibodies (ADAs)

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

Study Arms (5)

Part 1A

EXPERIMENTAL

Drug: BMS-986490

Part 2A - Colorectal Cancer (CRC)

EXPERIMENTAL

Drug: BMS-986490

Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC)

EXPERIMENTAL

Drug: BMS-986490

Part 1B

EXPERIMENTAL

Drug: BMS-986490; Drug: Bevacizumab

Part 2B

EXPERIMENTAL

Drug: BMS-986490; Drug: Bevacizumab

Interventions

BMS-986490 DRUG

Specified dose on specified days.

Part 1A; Part 1B; Part 2A - Colorectal Cancer (CRC); Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC); Part 2B

Bevacizumab DRUG

Specified dose on specified days.

Part 1B; Part 2B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of anaphylactic reactions to irinotecan and/or bevacizumab.
• Previously received therapy targeting CEACAM5.
• Grade ≥3 ILD/pneumonitis.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (6)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Tasman Oncology Research

Southport, Queensland, 4215, Australia

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: February 12, 2025
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): December 9, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (4); AU (1); CA (1)