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NOT YET RECRUITING
NCT07784374
PHASE2

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

Sponsor: Genfleet Therapeutics (Shanghai) Inc.

View on ClinicalTrials.gov

Summary

This is a phase 2 study. All subjects are patients with locally advanced unresectable or metastatic pancreatic cancer harboring KRAS G12D mutation who have received at least one prior line of systemic therapy. The purpose of this study is to evaluate the anti-tumor efficacy of GFH375 plus GFH276 versus GFH375 monotherapy, and to assess the impact of GFH375 plus GFS202A versus GFH375 monotherapy on patient body weight.

Official title: A Phase II, Multicenter, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of GFH375 in Combination With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-08-31

Completion Date

2029-08-31

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

GFH375

administered per protocol-specified schedule

DRUG

GFH276

administered per protocol-specified schedule

DRUG

GFS202A

administered per protocol-specified schedule

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China