Pancreatic Cancer
Conditions
Brief 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.
Interventions
Sponsors
Genfleet Therapeutics (Shanghai) Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | Up to approximately 3 years | Overall Survival (OS) |
| PFS | Up to approximately 2 years | Progression-Free Survival (PFS) Assessed by Investigator per RECIST Version 1.1 |
| ORR | Up to approximately 2 years | Objective Response Rate (ORR), Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1 |
| DCR | Up to approximately 2 years | Disease Control Rate (DCR)Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1 |
| DoR | Up to approximately 2 years | Duration of Response (DoR)Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1 |
| TTR | Up to approximately 2 years | Time-to-Response (TTR) Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1 |
| FAACT Scores | Up to approximately 2 years | Change from Baseline in FAACT-A/CS and FAACT-A/CS-5-Item Anorexia Symptom Scale (5IASS) Scores |
| L3SMI | Up to approximately 2 years | Change from Baseline in Third-Lumbar-Level Skeletal Muscle Index (L3SMI) |
| Change in third-lumbar-level fat area | Up to approximately 2 years | Change in Third-Lumbar-Level Intermuscular Fat Area, Subcutaneous Fat Area and Visceral Fat Area |
| The incidence and severity of AEs and SAEs | Up to approximately 2 years | The incidence and severity of AEs and SAEs |
| Plasma concentration of GFH375 | Up to approximately 2 years | Trough concentration of GFH375 |
| Plasma concentration of GFH276 | Up to approximately 2 years | Trough concentration of GFH276 |
| Plasma concentration of GFS202A | Up to approximately 2 years | Trough concentration of GFS202A |
Countries
China
Contacts
CONTACTLizhi Yi +86 21 6882 1388
Outcome results
None listed