# Garsorasib, a KRAS G12C inhibitor, with or without cetuximab, an EGFR antibody, in colorectal cancer cohorts of a phase II trial in advanced solid tumors with KRAS G12C mutation

Source: https://onco.cc/key-papers/paper-nct04585035-signal-transduct-target-ther-2025/  
OnCo record `paper-nct04585035-signal-transduct-target-ther-2025` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Published report from the trial registered as NCT04585035, in Signal transduction and targeted therapy (2025), chosen as the most cited paper whose own text cites the registry id.

## Summary

Mutations in the KRAS gene have long been implicated in the pathogenesis of colorectal cancer (CRC). KRAS G12C inhibitors overcome the "undruggable" challenge, enabling precision therapy. Garsorasib (D-1553), a highly potent and selective KRAS G12C inhibitor, has demonstrated promising anti-tumor activity and favorable safety profile in early clinical trials. We conducted an open-label, nonrandomized phase II trial (ClinicalTrials.gov, NCT04585035) to assess the safety and efficacy of garsorasib with or without cetuximab in KRAS G12C-mutated CRC. In the monotherapy cohort (n = 26), objective response rate (ORR) was 19.2% (95% CI, 6.6-39.4), disease control rate (DCR) was 92.3% (95% CI, 74.9-99.1), median progression-free survival (PFS) was 5.5 months (95% CI, 2.9-11.6) and median overall survival (OS) was 13.1 months (95% CI, 9.5-NE). In the combination cohort (n = 42), ORR was 45.2% (95% CI, 29.8-61.3), DCR was 92.9% (95% CI, 80.5-98.5), median PFS was 7.5 months (95% CI, 5.5-8.1), and median OS was not reached. Grade ≥3 treatment-related adverse events occurred in 5 (19.2%) and 6 (14.3%) patients in monotherapy and combination cohort, respectively. Garsorasib with or without cetuximab showed a promising efficacy and manageable safety profiles in heavily pretreated patients with KRAS G12C-mutated CRC, providing a potential new treatment approach for such population.

Indexed on Europe PMC as PubMed record 40523897 (DOI 10.1038/s41392-025-02274-z). Its abstract cites the registry id NCT04585035, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Signal transduction and targeted therapy
- Year: 2025
- DOI: 10.1038/s41392-025-02274-z
- Authors: Ruan DY, Wu HX, Xu Y, et al.
- What it means: This is the paper Europe PMC returns for registry id NCT04585035 with the most citations, so it is the natural first reading for anyone following the trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.

## Sources

- Signal Transduct Target Ther 2025: https://doi.org/10.1038/s41392-025-02274-z
- PubMed: https://pubmed.ncbi.nlm.nih.gov/40523897/
- Europe PMC: https://europepmc.org/article/MED/40523897
- ClinicalTrials.gov NCT04585035: https://clinicaltrials.gov/study/NCT04585035

## Connected records

- trials: [Study to Evaluate D-1553 in Subjects With Solid Tumors](https://onco.cc/trials/nct04585035/)

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