KRAS G12D inhibitor (ON/OFF) · small molecule

VS-7375

9 active trials, targeting KRAS G12D. Not approved for any biomarker on marked.bio yet.

Also known as GFH375.

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 G12D 9 10 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of VS-7375.

  1. Genfleet Therapeutics 5
  2. Verastem 4

Trials

Status

9 of 10 trials shown

  1. A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation

    Recruiting Phase 3 Genfleet Therapeutics Started 2026Primary completion 2030-06 NCT07668752

    VS-7375docetaxel

    …e to undergo tumor biopsy to obtain tissue samples for central laboratory confirmation of KRAS G12D mutation.

    KRAS G12DKRAS G12D Mutation, NSCLC (Non-small Cell Lung Cancer)

  2. A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer

    Recruiting Phase 2 Verastem Started 2026Primary completion 2027-06 NCT07659782

    VS-7375

    Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)

    KRAS G12DNon-Small Cell Lung Cancer

  3. A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation

    Recruiting Phase 2 Genfleet Therapeutics Started 2026Primary completion 2028-08 NCT07784374

    VS-7375GFH276GFS202A

    …reviously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation

    KRAS G12DPancreatic Cancer

  4. A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer

    Recruiting Phase 2 Verastem Started 2026Primary completion 2027-06 NCT07659795

    VS-7375cetuximabpanitumumabmFOLFOX6

    Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)

    KRAS G12DColorectal Cancer

  5. GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 Genfleet Therapeutics Started 2026Primary completion 2027-04 NCT07554859

    VS-7375cetuximabpemetrexed

    Have a written report confirming KRAS G12D mutation positive.

    KRAS G12DNSCLC (Advanced Non-small Cell Lung Cancer)

  6. A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer

    Recruiting Phase 2 Verastem Started 2026Primary completion 2027-06 NCT07644559

    VS-7375cetuximabpanitumumab

    Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)

    KRAS G12DPancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS

  7. A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors

    Recruiting Phase 1/2 Verastem Started 2025Primary completion 2028-12 NCT07020221

    VS-7375cetuximabcarboplatinpemetrexedpembrolizumabgemcitabinenab-paclitaxeldefactinibmidazolamRepaglinide

    …cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.

    KRAS G12DPancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Adult

  8. A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation

    Recruiting Phase 1/2 Genfleet Therapeutics Started 2025Primary completion 2027-07 NCT07259590

    VS-7375cetuximabpaclitaxelgemcitabine

    …or cytologically confirmed locally advanced unresectable or metastatic solid tumors, with KRAS G12D mutation.

    KRAS G12DAdvanced Solid Tumors Cancer, PDAC, CRC (Colorectal Cancer)

  9. A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations

    Recruiting Phase 1/2 Genfleet Therapeutics Started 2024Primary completion 2028-07 NCT06500676

    VS-7375

    …h histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation.

    KRAS G12DKRAS G12D Mutations, Advanced Solid Tumors