This is a study of a Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants with Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received at least 2 Prior Lines of Therapy. The primary objective of this study is to determine Overall Survival (OS) of IBI343 plus best supportive care (BSC) compared with placebo plus BSC.
Sign the written informed consent form (ICF) and be willing and able to comply with the visits and related procedures stipulated in the plan.
Histologically confirmed unresectable locally advanced, or metastatic pancreatic cancer.
Have received and progression after at least two systemic therapies(must including a fluorouracil-based and a gemcitabine-based therapy).
ECOG PS score of 0 or 2.
Participation in another interventional study, except observational or post-intervention follow-up.
Prior treatment with topoisomerase inhibitor-based ADC.
Has received the last dose of an anti-cancer therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment.
Plans to receive other anti-tumor treatments during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed) .
Parallel
IBI343
DrugSubjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle
Placebo
DrugSubjects in the control arm will receive placebo 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle
overall survival(OS)
Overall survival (OS) is defined as the time from randomization to death from any cause.
progression free survival(PFS)
Progression-free survival (PFS) is defined as the time from random assignment in the trial to disease progression or death from any cause.
Objective response rate (ORR)
ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) per RECIST v1.1.
disease control rate (DCR)
DCR is defined as the proportion of subjects in the analysis population who achieve disease control (CR, PR, or SD) per RECIST v1.1 criteria.
duration of response (DoR)
DoR is defined as the time from the first CR or PR to disease progression or death from any cause, whichever occurs first for subjects with ORR per RECIST v1.1 criteria.
Click on the lead sponsor to view all of their trials.
