KRAS G12C inhibitor (OFF state) · small molecule

fulzerasib

8 active trials across 2 of our biomarkers, targeting KRAS G12C. Not approved for any biomarker on marked.bio yet.

Also known as IBI351, GFH925.

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 8 11 Phase 3
KRAS G12D 1 1 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of fulzerasib.

  1. Jiangsu Hengrui 1
  2. Innovent Biologics 1

Trials

Status

8 of 11 trials shown

  1. A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment

    Not yet recruiting Phase 3 Jiangsu Hengrui Started 2026Primary completion 2028-05 NCT07601048

    HRS-7058fulzerasibgarsorasibglecirasib

    …enter Phase III Trial of HRS-7058 Versus the Investigator-Selected KRAS G12C Inhibitor in KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Stand…

    KRAS G12CKRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment

  2. Neoadjuvant Treatment of Fulzerasib Plus Cetuximab N01 in KRAS G12C Mutated Locally Advanced Colorectal Cancer With or Without Resectable Metastases

    Recruiting Phase 2 Zhejiang University Started 2026Primary completion 2028-12 NCT07581912

    fulzerasibcetuximab

    PMMR/MSS, KRAS G12C mutation, and both NRAS and BRAF wild-type

    KRAS G12CColorectal Cancer, KRAS G12C Mutant Advanced Solid Tumors, Fulzerasib, Cetuximab N01

  3. Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC

    Recruiting Phase 2 Jianxing He Started 2026Primary completion 2027-03 NCT07492342

    fulzerasibsintilimab

    All subjects must have a written test report before enrollment to prove the presence of KRAS G12C mutation

    KRAS G12CResectable NSCLC, KRAS G12C Mutation, Stage IB-IIIA NSCLC, Neoadjuvant Therapy

  4. Tunlametinib Combination Therapy in KRAS-Mutated Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 Sun Yat-sen University Started 2026Primary completion 2028-05 NCT07463677

    cetuximabfulzerasib

    Positive for KRAS driver gene mutations (including: KRAS G12C and KRAS non-G12C).

    KRAS G12CKRAS G12DLung Cancer (NSCLC)

  5. IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

    Recruiting Phase 2 Guangdong Association of Clinical Trials Started 2025Primary completion 2027-09 NCT07198841

    fulzerasibcetuximab

    Documented KRAS G12C mutation confirmed by a written report from a certified laboratory.

    KRAS G12CLung Cancer (Non-Small Cell)

  6. A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Fulzerasib (IBI351) in Combination With Ivonescimab (AK-112) in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer Patients With KRAS G12C Mutation

    Not yet recruiting Phase 2 Shanghai Chest Hospital Started 2025Primary completion 2027-04 NCT06936644

    fulzerasibivonescimab

    All subjects must have a written test report before enrollment to prove the presence of KRAS G12C mutation

    KRAS G12CKRAS G12C Lung Cancer

  7. The Efficacy and Safety of IBI351, Cetuximab β Combined With FOLFIRI as First-line /IBI351, Cetuximab β as Second-line in the Treatment of KRAS G12C-mutated Metastatic Colorectal Cancer

    Enrolling by invitation Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2025Primary completion 2027-05 NCT06959589

    fulzerasibcetuximabFOLFIRI

    There is a written test report proving the presence of KRASG12C mutation: PCR method or NGS method detection clearly indicates KRASG12C mutation 4.

    KRAS G12CColorectal Cancer Metastatic, KRAS G12C Mutation

  8. Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

    Recruiting Phase 1 Innovent Biologics Started 2022Primary completion 2025-05 NCT05504278

    fulzerasibcetuximabpemetrexedcarboplatinsintilimabcisplatin

    Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation

    KRAS G12CAdvanced Non-Small Cell Lung Cancer