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GFH375

DRUG6 trials

Sponsors

Genfleet Therapeutics (Shanghai) Inc.

Conditions

Advanced Solid TumorsAdvanced Solid Tumors CancerCRC (Colorectal Cancer)KRAS G12D MutationKRAS G12D MutationsMetastatic Pancreatic CancerNSCLC (Non-small Cell Lung Cancer)PDAC

Phase 1

A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
RecruitingNCT06500676
Genfleet Therapeutics (Shanghai) Inc.Advanced Solid Tumors, KRAS G12D Mutations
Start: 2024-07-09End: 2028-12-31Target: 407Updated: 2025-11-20
A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation
RecruitingNCT07259590
Genfleet Therapeutics (Shanghai) Inc.Advanced Solid Tumors Cancer, CRC (Colorectal Cancer), PDAC
Start: 2025-10-21End: 2027-07-31Target: 126Updated: 2025-12-02

Phase 2

A Phase II Study to Evaluate GFH375 in Patients With KRAS G12D Mutant Metastatic Pancreatic Cancer
WithdrawnNCT07026916
Genfleet Therapeutics (Shanghai) Inc.Metastatic Pancreatic Cancer
Start: 2025-08-31End: 2028-08-31Updated: 2025-11-17
A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation
Not yet recruitingNCT07784374
Genfleet Therapeutics (Shanghai) Inc.Pancreatic Cancer
Start: 2026-08-31End: 2029-08-31Target: 120Updated: 2026-08-25

Phase 3

Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer
RecruitingNCT07262567
Genfleet Therapeutics (Shanghai) Inc.Metastatic Pancreatic Cancer
Start: 2025-12-04End: 2028-06-01Target: 320Updated: 2026-08-14
A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation
RecruitingNCT07668752
Genfleet Therapeutics (Shanghai) Inc.KRAS G12D Mutation, NSCLC (Non-small Cell Lung Cancer)
Start: 2026-07-27End: 2031-04-30Target: 300Updated: 2026-08-10

Related Papers

Oral KRAS G12D inhibitor GFH375 for previously treated advanced solid tumors with KRAS<sup>G12D</sup> mutations: a phase 1 trial.
2026-09-15
Preliminary efficacy of GFH375 in patients with advanced cholangiocarcinoma or colorectal cancer harboring KRAS G12D mutation.
Journal of Clinical Oncology2026-05-27
Abstract 7100: VS-7375: An oral, selective KRAS G12D dual ON/OFF inhibitor with potent anti-tumor activity as a single agent and in combination with other agents
Cancer Research2026-04-03
Abstract PR007: Anti-tumor efficacy of the selective oral KRAS G12D dual ON/OFF inhibitor VS-7375 as a single agent and in combination with targeted agents
Cancer Research2026-03-05
Abstract A076: VS-7375: An oral, selective KRAS G12D dual ON/OFF inhibitor with superior anti-tumor efficacy relative to ON-only KRAS inhibitors
Molecular Cancer Therapeutics2025-10-22
A first-in-human phase I/II study of GFH375, a highly selective and potent oral KRAS G12D inhibitor in patients with KRAS G12D mutant advanced solid tumors.
Journal of Clinical Oncology2025-05-285 citations
Abstract 4394: GFH375 (VS-7375): An oral, selective KRAS G12D (ON/OFF) inhibitor with potent anti-tumor efficacy as single agent and in combination with other anticancer therapies in preclinical models
Cancer Research2025-04-213 citations