# CodeBreaK 100 (pancreatic cancer cohort)

Source: https://onco.cc/trials/codebreak-100/  
OnCo record `codebreak-100` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

CodeBreaK 100 gave the first KRAS inhibitor to 38 people whose pancreatic cancer carried the rare G12C mutation and had progressed after chemotherapy; one in five tumours shrank and patients lived a median 6.9 months, proof that KRAS can be drugged in this disease even though the target is uncommon here.

## Summary

The pooled phase 1 and 2 pancreatic cohort of CodeBreaK 100 treated 38 patients, all metastatic and previously treated (median two prior lines, range one to eight). Eight had a centrally confirmed objective response (21 percent, 95 percent confidence interval 10 to 37); median progression-free survival was 4.0 months (2.8 to 5.6) and median overall survival 6.9 months (5.0 to 9.1). Treatment-related adverse events occurred in 16 patients (42 percent), grade 3 in six (16 percent), with no fatal events or discontinuations. Sotorasib has no pancreatic indication from the FDA (label: KRAS G12C lung cancer and, with panitumumab, colorectal cancer) or the EMA, and NICE's TA781 covers lung cancer only; NCCN lists sotorasib and adagrasib (KRYSTAL-1: 7 of 21 responses) as options for KRAS G12C pancreatic cancer after first-line therapy, and daraxonrasib, which covers G12C among all RAS G12 mutations, is now approved in the United States for previously treated metastatic disease regardless of subtype.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Also known as: CodeBreaK100; CodeBreak 100; AMG 510 phase 1/2
- Registry id: NCT03600883
- Phase: 1/2
- Setting: Previously treated metastatic KRAS G12C-mutated pancreatic cancer (about 1 to 2 percent of pancreatic tumours), single group: sotorasib 960 mg once daily, with centrally confirmed objective response as the phase 2 primary endpoint
- Sponsor: Amgen
- Enrolled: 38
- Result: Objective response 21 percent (8 of 38; 95 percent confidence interval 10 to 37); median progression-free survival 4.0 months; median overall survival 6.9 months; grade 3 treatment-related adverse events 16 percent.
- Outcomes: Objective response (central review): Sotorasib 960 mg daily 21%; Overall survival: Sotorasib 960 mg daily 6.9 months

## Sources

- ClinicalTrials.gov NCT03600883: https://clinicaltrials.gov/study/NCT03600883
- Strickler et al., sotorasib in KRAS p.G12C-mutated advanced pancreatic cancer (NEJM 2023): https://doi.org/10.1056/NEJMoa2208470
- Lumakras label (openFDA): indications, no pancreatic cancer indication: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22LUMAKRAS%22

## Connected records

- cancers: [KRAS G12C-mutant pancreatic ductal adenocarcinoma](https://onco.cc/cancers/kras-g12c-pdac/), [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- technologies: [KRAS & RAS inhibitors](https://onco.cc/technologies/kras-inhibitors/)
- targets: [KRAS](https://onco.cc/targets/kras/)
- drugs: [Daraxonrasib](https://onco.cc/drugs/daraxonrasib/), [Sotorasib](https://onco.cc/drugs/sotorasib/)
- companies: [Amgen](https://onco.cc/companies/amgen/)
- terms: [KRAS mutation subtypes (G12C, G12D, G12V)](https://onco.cc/terms/kras-mutation-subtypes/)
- trials: [Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1](https://onco.cc/trials/nct03785249/), [RASolute 302](https://onco.cc/trials/rasolute-302/)
- people: [John H. Strickler](https://onco.cc/people/john-strickler/)

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JSON: https://onco.cc/api/v1/entities/codebreak-100.json