This Phase 1 study will be a multicenter, single agent, dose escalation and dose expansion study conducted in patients with advanced late stage cancer (pancreatic or gastric including esophageal junction cancers) for which the investigator determines there to be no other standard of care or higher priority therapies available.
This Phase 1 study will be a multicenter, single agent, dose escalation and dose expansion study conducted in patients with advanced late stage cancer (pancreatic or gastric including esophageal junction cancers) for which the investigator determines there to be no other standard of care or higher priority therapies available. All patients must have failed standard first or later lines of systemic therapy. The study design overview is presented below. The study will consist of 2 parts, Part A and Part B. Part A will explore once every 3 weeks (Q3W) dosing per standard 3+3 dose escalation design. Upon attaining a RP2D, Part B will commence in 2 groups, in approximately 15 patients with advanced pancreatic cancer and 15 patients with advanced gastric including gastric esophageal junction cancers. Part B will seek to confirm the RP2D and will also seek early signals of efficacy in the selected cancer patient populations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Anti-claudin 18.2 Antibody-MMAE Drug Conjugate
Number of participants with dose-limiting toxicities (DLTs) during the DLT evaluation period.
DLTs are assessed during the first cycle (21 days) in each cohort to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Time frame: through study completion, an average of 3 year
Number of participants with treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship.
TEAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0.
Time frame: through study completion, an average of 3 year
Number of participants with clinically significant changes in vital signs
Number of participants with clinically significant changes in vital signs
Time frame: through study completion, an average of 3 year
Number of participants with clinically significant changes in clinical laboratory tests
Number of participants with clinically significant changes in clinical laboratory tests
Time frame: through study completion, an average of 3 year
CPO102 pharmacokinetics: Area under the concentration time curve over the dosing interval.
CPO102 pharmacokinetics: Area under the concentration time curve over the dosing interval.
Time frame: through study completion, an average of 3 year
CPO102 pharmacokinetics: Maximum concentration of the drug (Cmax)
CPO102 pharmacokinetics: Maximum concentration of the drug (Cmax)
Time frame: through study completion, an average of 3 year
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CPO102 pharmacokinetics: Time to maximum concentration (Tmax)
CPO102 pharmacokinetics: Time to maximum concentration (Tmax)
Time frame: through study completion, an average of 3 year
CPO102 pharmacokinetics: Elimination half-life (t1/2)
CPO102 pharmacokinetics: Elimination half-life (t1/2)
Time frame: through study completion, an average of 3 year
CPO102 pharmacokinetics: Clearance (CL)
CPO102 pharmacokinetics: Clearance (CL)
Time frame: through study completion, an average of 3 year
CPO102 Objective response rate (ORR)
ORR is defined as the proportion of patients in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 is observed as best overall response.
Time frame: through study completion, an average of 3 year
CPO102 immunogenicity: Number of participants with anti-drug-antibody (ADA)
CPO102 immunogenicity: Number of participants with anti-drug-antibody (ADA)
Time frame: through study completion, an average of 3 year