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.
Study ID
NCT07784374
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • GFH375 — DRUG
    administered per protocol-specified schedule
  • GFH276 — DRUG
    administered per protocol-specified schedule
  • GFS202A — DRUG
    administered per protocol-specified schedule

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GFH375+GFH276
  • Experimental: GFH375+GFS202A
  • Experimental: GFH375

Primary Outcome Measure

PFS [ Time Frame: Up to approximately 2 years ]

Central Contacts

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