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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Bevacizumab; Drug: BMS-986490

Study type: Interventional

Funder types: Industry

Identifiers

NCT06730750

CA238-0001

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, 3L+ NSCLC:.

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

ii) Progressed on at least 2 prior lines of therapy,

iii) 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 5 patient groups

Part 1A

Experimental group

Treatment:

Drug: BMS-986490

Part 2A - Colorectal Cancer (CRC)

Experimental group

Treatment:

Drug: BMS-986490

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

Experimental group

Treatment:

Drug: BMS-986490

Part 1B

Experimental group

Treatment:

Drug: BMS-986490

Drug: Bevacizumab

Part 2B

Experimental group

Treatment:

Drug: BMS-986490

Drug: Bevacizumab