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.
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.
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.
Parallel
GFH375
Drugadministered per protocol-specified schedule
GFH276
Drugadministered per protocol-specified schedule
GFS202A
Drugadministered per protocol-specified schedule
PFS
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1
Weight
Percentage Change in Body Weight From Baseline at Week 12
OS
Overall Survival (OS)
PFS
Progression-Free Survival (PFS) Assessed by Investigator per RECIST Version 1.1
ORR
Objective Response Rate (ORR), Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1
DCR
Disease Control Rate (DCR)Assessed by Blinded Independent Central Review (BICR) and Investigator per RECIST Version 1.1
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