This is a multicenter, open-label, Phase II umbrella study conducted in participants with advanced or metastatic pancreatic cancer. This study has set up different cohorts to evaluate the efficacy and safety of multiple investigational products in pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
q3w
Objective response rate (ORR)
ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to approximately 24 months.
Progression-free survival (PFS)
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Time frame: Up to approximately 24 months.
Duration of Response (DOR)
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Time frame: Up to approximately 24 months.
Disease control rate (DCR)
Assessed by the investigators as per RECIST v1.1
Time frame: Up to approximately 24 months.
Overall Survival (OS)
Time from start of treatment to death due to any reason.
Time frame: Up to approximately 24 months.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results.
Time frame: Up to approximately 24 months.
Maximum Plasma Concentration (Cmax) of the investigational product
Blood Samples will be collected to determine the Cmax of the investigational product in the plasma.
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Time frame: Up to approximately 24 months.
Minimum Plasma Concentration (Cmin) of the investigational product
Blood Samples will be collected to determine the Cmin of the investigational product in the plasma.
Time frame: Up to approximately 24 months.
Immunogenicity of the investigational product
Incidence of anti-drug antibody (ADA) against the investigational product.
Time frame: Up to approximately 24 months.