The study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebrelimab, or with adebrelimab and other antitumor agents in patients with advanced pancreatic ductal adenocarcinoma (PDAC).
This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of HRS-4642 combined with adebrelimab, or with adebrelimab and other antitumor agents in the treatment of patients with advanced PDAC. This study experiment is divided into two stages: dose exploration stage and efficacy exploration stage. Additional arms may be added based on emerging data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGDose Limited Toxicity (DLT)
A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illness
Time frame: Day 1 to Day 21 after the first combination therapy was administrated
Recommended phase II dose (RP2D)
RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages.
Time frame: Approximately 12 months
Objective Response Rate (ORR)
Evaluated by RECIST v1.1.
Time frame: Up to approximately 12 months
Disease Control Rate (DCR)
Evaluated by RECIST v1.1.
Time frame: Up to approximately 12 months
Duration of Response (DOR)
Evaluated by RECIST v1.1.
Time frame: Up to approximately 12 months
Progression Free Survival (PFS)
Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Time frame: Up to approximately 12 months
Overall survival (OS)
Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Time frame: Up to approximately 12 months
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Specified dose on specified days
Adverse events (AEs)
AEs are assessed by NCI-CTCAE v5.0
Time frame: From the first drug administration to within 90 days for the last adebrelimab dose