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Recruiting Phase 2

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

NCT07784374 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-08-20
Last updated
2026-10-02

Condition(s) studied

Pancreatic Cancer

Investigational drug(s) / intervention(s)

GFH375 →GFH276 →GFS202A →

GFH375: administered per protocol-specified schedule

GFH276: administered per protocol-specified schedule

GFS202A: administered per protocol-specified schedule

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Able to provide written informed consent prior to any study-related procedures. * Male or female subjects aged between 18 and 80 years (inclusive) at the time of informed consent. * Histologically or cytologically confirmed pancreatic adenocarcinoma. * Estimated life expectancy ≥ 3 months as judged by the investigator. * Has received at least 1 prior line of systemic anti-tumor therapy. * Has at least one measurable lesion per RECIST version 1.1. * Adequate organ function. Exclusion Criteria: * Other malignancy that has progressed or required treatment within 3 years prior to study entry. * Active central nervous system (CNS) metastases. * Prior treatment with KRAS G12D-specific or pan-RAS/KRAS targeted agents. * Clinically significant severe cardiovascular disease. * Stroke or other severe cerebrovascular events within 6 months prior to randomization. * Significant acute or chronic infectious disease. * Severe psychiatric disorder, history of drug abuse, or significant alcohol abuse. * Pregnant or lactating female subjects. * Other conditions that, in the investigator's opinion, make the subject unsuitable for study participation.

Primary outcome measure(s)

  • PFS — Up to approximately 2 years
    Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1
  • Weight — Baseline, From first study treatment to Week 12
    Percentage Change in Body Weight From Baseline at Week 12

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07784374 on ClinicalTrials.gov ↗ ← All trials in China