Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
NCT Number: NCT07784374
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200025, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
administered per protocol-specified schedule
administered per protocol-specified schedule
administered per protocol-specified schedule
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1
Time frame: Baseline, From first study treatment to Week 12
Percentage Change in Body Weight From Baseline at Week 12
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS) Assessed by Investigator per RECIST Version 1.1
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
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
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
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
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
Time frame: Up to approximately 2 years
Change from Baseline in Third-Lumbar-Level Skeletal Muscle Index (L3SMI)
Time frame: Up to approximately 2 years
Change in Third-Lumbar-Level Intermuscular Fat Area, Subcutaneous Fat Area and Visceral Fat Area
Time frame: Up to approximately 2 years
The incidence and severity of AEs and SAEs
Time frame: Up to approximately 2 years
Trough concentration of GFH375
Time frame: Up to approximately 2 years
Trough concentration of GFH276
Time frame: Up to approximately 2 years
Trough concentration of GFS202A
Contact information is provided by the study sponsor or research team.
Genfleet Therapeutics (Shanghai) Inc.
Industry
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
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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.
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