marked.bio

KRAS G12C inhibitor (OFF state) · small molecule

garsorasib

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

Also known as D-1553.

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 10 12 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of garsorasib.

  1. InxMed 2
  2. InventisBio 2
  3. Jiangsu Hengrui 1
  4. Chia Tai Tianqing (Sino Biopharm) 1

Trials

10 of 12 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. A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation

    Recruiting Phase 3 InxMed Started 2025Primary completion 2028-09 NCT07174908

    ifebemtinibgarsorasibpemetrexed

    Has KRAS G12C mutation confirmed by central laboratory

    KRAS G12CNon-Small Cell Lung Cancer

  3. D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure

    Recruiting Phase 3 Chia Tai Tianqing (Sino Biopharm) Started 2024Primary completion 2026-10 NCT06300177

    garsorasibdocetaxel

    D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior S…

    KRAS G12CStatus may be outdated, last updated 2024-04-26Non Small Cell Lung Cancer

  4. Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study)

    Recruiting Phase 2 Guangdong Provincial People's Hospital Started 2026Primary completion 2027-12 NCT07472478

    garsorasibivonescimab

    Mutation Status: KRAS G12C mutation positivity must be confirmed by next-generation sequencing (NGS) or polymerase c…

    KRAS G12CLung Cancer (NSCLC), KRAS G12C Lung Cancer

  5. Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC

    Not yet recruiting Phase 2 Sun Yat-sen University Started 2025Primary completion 2028-10 NCT07294261

    garsorasibbenmelstobartanlotinibcetuximab

    Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC

    KRAS G12CLocal Advanced or Metastatic NSCLC

  6. Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GH21 Capsules Combined With D-1553 Tablets in Subjects With Locally Advanced or Metastatic Solid Tumors With the KRASG12C Mutation

    Not yet recruiting Phase 2 Suzhou Genhouse Bio Started 2025Primary completion 2026-12 NCT07318649

    garsorasib

    …or cytologically confirmed locally advanced or metastatic non-small cell lung cancer with KRASG12C mutation who have failed standard therapy or no standard therapy and have been treated wi…

    KRAS G12CLocally Advanced or Metastatic Solid Tumors

  7. GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors

    Not yet recruiting Phase 1/2 Suzhou Genhouse Bio Started 2024Primary completion 2027-09 NCT06435455

    GH21garsorasib

    KRAS G12C mutant advanced solid tumor;

    KRAS G12CStatus may be outdated, last updated 2024-07-08Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation

  8. Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors

    Active, not recruiting Phase 1/2 InventisBio Started 2022Primary completion 2027-12 NCT05379946

    garsorasibifebemtinib

    Subject has KRasG12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells…

    KRAS G12CSolid Tumor

  9. a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors

    Active, not recruiting Phase 1/2 InxMed Started 2022Primary completion 2027-12 NCT06166836

    garsorasibifebemtinib

    Confirmed positive KRAS G12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells…

    KRAS G12CSolid Tumor

  10. Study to Evaluate D-1553 in Subjects With Solid Tumors

    Active, not recruiting Phase 1/2 InventisBio Started 2020Primary completion 2024-04 NCT04585035

    garsorasibpembrolizumabcetuximab

    Subject has KRasG12C mutation in tumor tissue or other bio-specimens containing cancer cells or DNA.

    KRAS G12CSolid Tumor, Adult, NSCLC, CRC