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Phase 1/2 Open-label Study of BMS-986466 in Combination with Adagrasib with or without Cetuximab in Participants with KRAS G12C-mutant Advanced Solid Tumors

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505070-15-00
Acronym
CA126-0015
Enrollment
62
Registered
2024-01-23
Start date
Unknown
Completion date
2024-03-15
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC and CRC, Oncology

Brief summary

Incidence of Dose Limiting Toxicities, Adverse Events, Serious Adverse Events, Adverse Events leading to discontinuation, and deaths., Overall Response Rate (ORR) per RECIST v1.1 by Blinded Independent Central Review (BICR).

Detailed description

Summary measures of BMS-986466 PK parameters in plasma including Maximum concentration (Cmax), Time to maximum concentration (Tmax), and Area Under the Curve (AUC(0-T)) from concentration-time data., Progression Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), and Time To Response (TTR) per RECIST v1.1 by BICR., Incidence of Dose Limiting Toxicities, Adverse Events, Serious Adverse Events, Adverse Events leading to discontinuation, and deaths., Summery measures of target engagement (ability of a drug to bind to a specific molecule)

Interventions

DRUGCETUXIMAB
DRUGADAGRASIB

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of Dose Limiting Toxicities, Adverse Events, Serious Adverse Events, Adverse Events leading to discontinuation, and deaths., Overall Response Rate (ORR) per RECIST v1.1 by Blinded Independent Central Review (BICR).

Secondary

MeasureTime frame
Summary measures of BMS-986466 PK parameters in plasma including Maximum concentration (Cmax), Time to maximum concentration (Tmax), and Area Under the Curve (AUC(0-T)) from concentration-time data., Progression Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), and Time To Response (TTR) per RECIST v1.1 by BICR., Incidence of Dose Limiting Toxicities, Adverse Events, Serious Adverse Events, Adverse Events leading to discontinuation, and deaths., Summery measures of target engagement (ability of a drug to bind to a specific molecule)

Countries

Belgium, Finland, France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026