marked.bio

KRAS G12C inhibitor (OFF state) · small molecule

opnurasib

3 active trials, targeting KRAS G12C. Not approved for any biomarker on marked.bio yet.

Also known as JDQ443.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
KRAS G12C 3 5 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of opnurasib.

  1. Novartis 3

Trials

3 of 5 trials shown

  1. Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

    Active, not recruiting Phase 3 Novartis Started 2022Primary completion 2026-09 NCT05132075

    opnurasibdocetaxel

    Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novart…

    KRAS G12CNon-Small Cell Lung Cancer

  2. Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.

    Active, not recruiting Phase 2 Novartis Started 2022Primary completion 2024-11 NCT05445843

    opnurasib

    Presence of a KRAS G12C mutation (all participants) and:

    KRAS G12CLocally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation

  3. Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

    Active, not recruiting Phase 1/2 Novartis Started 2021Primary completion 2027-01 NCT04699188

    opnurasibbatoprotafibtislelizumab

    Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to…

    KRAS G12CKRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal, Cancer of Lung