A Phase II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of IBI343 in combination therapy for patients with advanced malignant solid tumors.To evaluate the efficacy and safety of IBI343 in combination therapy for patients with advanced malignant solid tumors.Enrollment of subjects with advanced gastric/gastroesophageal junction adenocarcinoma positive for CLDN18.2, and subjects with pancreatic ductal adenocarcinoma positive for CLDN18.2.
Signed written informed consent, willing and able to comply with the protocol-specified visits and related procedures.
At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Age ≥ 18 years, no gender restrictions.
An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Currently participating in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the survival follow-up phase of an interventional study.
Received treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the investigational drug.
Received the last anti-tumor treatment within 4 weeks or 5 half-lives of the anti-tumor therapy (whichever is shorter) before the first dose of the investigational drug.
Received therapeutic or palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.
Single group
IBI343,Gemcitabine, Albumin-bound Paclitaxel
DrugIBI343,Gemcitabine, Albumin-bound Paclitaxel intravenous infusion
Objective Response Rate (ORR) evaluated according to RECIST v1.1
Incidence of Adverse Events (AE)
Incidence of treatment-emergent adverse Events (TEAE)
Incidence of adverse events of Special Interest (AESI)
Duration of Response (DoR) evaluated according to RECIST v1.1
Disease Control Rate (DCR) evaluated according to RECIST v1.1
Time to Response (TTR) evaluated according to RECIST v1.1
Progression-Free Survival (PFS) evaluated according to RECIST v1.1
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