# CodeBreaK 100 (NCT03600883)

> A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

No report yet. It can be ordered.

## Registry

- Registry record: https://clinicaltrials.gov/study/NCT03600883
- Phase: PHASE1, PHASE2
- Status: COMPLETED
- Sponsor: Amgen
- Conditions: KRAS p.G12C Mutant Advanced Solid Tumors
- Interventions: sotorasib; Anti PD-1/L1; Midazolam
- Enrollment: 713
- Primary outcome: Primary: Number of subjects with treatment-emergent adverse events
- Primary outcome: Primary: Number of subjects with treatment-related adverse events
- Primary outcome: Primary: Number of subjects with grade ≥3 treatment-emergent adverse events
- Primary outcome: Primary: Number of subjects with serious adverse events
- Primary outcome: Primary: Number of subjects with adverse events of interest
- Primary outcome: Primary: Number of subjects with clinically significant changes in vital signs
- Primary outcome: Primary: Number of subjects with clinically significant changes in physical examination results
- Primary outcome: Primary: Number of subjects with clinically significant changes on electrocardiograms (ECGs)
- Primary outcome: Primary: Number of subjects with clinically significant changes in clinical laboratory values
- Primary outcome: Primary: Number of subjects with dose-limiting toxicities (DLTs)
- Primary outcome: Primary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria
- Primary outcome: Primary: Duration of response (DOR) as assessed by RECIST 1.1 criteria
- Primary outcome: Primary: Disease control as assessed by RECIST 1.1 criteria
- Primary outcome: Primary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria
- Primary outcome: Primary: Time to response (TTR) as assessed by RECIST 1.1 criteria

## Preliminary discovery

Commentary in our index that names this trial so far. Final coverage is set when the report is built.

- X threads: 19
- Podcasts: 11
- YouTube: 9

## Order

Deep, $1,950, price fixed at order: https://www.erudio.com/contact?report=codebreak-100-nct03600883

## Free preview

POST https://www.erudio.com/api/trial-requests with {"nct_id": "NCT03600883", "email": "<work email>"}; the inbox owner confirms by the emailed link.