Clinical trial · no report yet · Phase 1/Phase 2

NCT06500676

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

NCT06500676 ↗
Recruiting
Genfleet Therapeutics (Shanghai) Inc.
3 commentary sources found
Focused

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built. Commentary is thin so far, so the report would be short.

Channel	Found
X threads	3

The trial

ClinicalTrials.gov

Official title: An Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GFH375 in Patients With KRAS G12D Mutant Advanced Solid Tumors
Phase: Phase 1/Phase 2
Status: Recruiting
Conditions: KRAS G12D Mutations; Advanced Solid Tumors
Interventions: GFH375
Arms: GFH375 · Experimental
Enrollment: 407 (estimated)
Primary outcomes: Phase Ia:The incidence and severity of AEs and SAEs
Phase Ia:The incidence of DLT events
Phase Ib:The incidence and severity of AEs and SAEs
Phase II:Overall response rate (ORR)
Sponsor: Genfleet Therapeutics (Shanghai) Inc.
Start: Jul 9, 2024
Primary completion: Jul 31, 2028 (estimated)
Results posted: No
Registry record: NCT06500676 · updated Nov 20, 2025

Publications

linked from the registry

Ai X, Song Z, Wu L, Zhou A, Cheng D, Zong H, Wu H, Niu Z, Sun Y, Zhu L, Li Z, Deng Y, Yuan Y, Qu X, Zhao H, Du Y, Li Z, Wang Y, Shen H, Zhu H, Zheng C, Wang S, Cui Z, Tai L, Lu S. Oral KRAS G12D inhibitor GFH375 for previously treated advanced solid tumors with KRASG12D mutations: a phase 1 trial. Nat Med. 2026 Sep;32(9):3302-3312. doi: 10.1038/s41591-026-04559-4. Epub 2026 Sep 15. PubMed 42745055