Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07784374

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GFH375

Drug

administered per protocol-specified schedule

GFH276

Drug

administered per protocol-specified schedule

GFS202A

Drug

administered per protocol-specified schedule

Primary outcomes

  1. PFS

    Time frame: Up to approximately 2 years

    Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1

  2. Weight

    Time frame: Baseline, From first study treatment to Week 12

    Percentage Change in Body Weight From Baseline at Week 12

Secondary outcomes

  1. OS

    Time frame: Up to approximately 3 years

    Overall Survival (OS)

  2. PFS

    Time frame: Up to approximately 2 years

    Progression-Free Survival (PFS) Assessed by Investigator per RECIST Version 1.1

  3. ORR

    Time frame: Up to approximately 2 years

    Objective Response Rate (ORR), Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1

  4. DCR

    Time frame: Up to approximately 2 years

    Disease Control Rate (DCR)Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1

  5. DoR

    Time frame: Up to approximately 2 years

    Duration of Response (DoR)Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1

  6. TTR

    Time frame: Up to approximately 2 years

    Time-to-Response (TTR) Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1

  7. FAACT Scores

    Time frame: Up to approximately 2 years

    Change from Baseline in FAACT-A/CS and FAACT-A/CS-5-Item Anorexia Symptom Scale (5IASS) Scores

  8. L3SMI

    Time frame: Up to approximately 2 years

    Change from Baseline in Third-Lumbar-Level Skeletal Muscle Index (L3SMI)

  9. Change in third-lumbar-level fat area

    Time frame: Up to approximately 2 years

    Change in Third-Lumbar-Level Intermuscular Fat Area, Subcutaneous Fat Area and Visceral Fat Area

  10. The incidence and severity of AEs and SAEs

    Time frame: Up to approximately 2 years

    The incidence and severity of AEs and SAEs

  11. Plasma concentration of GFH375

    Time frame: Up to approximately 2 years

    Trough concentration of GFH375

  12. Plasma concentration of GFH276

    Time frame: Up to approximately 2 years

    Trough concentration of GFH276

  13. Plasma concentration of GFS202A

    Time frame: Up to approximately 2 years

    Trough concentration of GFS202A

Study contacts

Contact information is provided by the study sponsor or research team.

Lizhi Yi +86 21 6882 1388

CONTACT

[email protected]

+86 21 6882 1388

Sponsors and collaborators

Lead sponsor

Genfleet Therapeutics (Shanghai) Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.