Gastric Cancer, Pancreatic Cancer
Conditions
Keywords
Claudin 18.2 ADC, Phase 1, CPO102, Pancreatic Cancer, Gastric Cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGCPO102
Anti-claudin 18.2 Antibody-MMAE Drug Conjugate
Sponsors
CSPC Megalith Biopharmaceutical Co.,Ltd.
Conjupro Biotherapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Applicable to all patients in both Part A and Part B of the study: * Pathological diagnosis (histological) of pancreatic or gastric including esophageal junction cancers. * Patient must provide archived tissue block or formalin-fixed paraffin-embedded (FFPE) slides or fresh biopsy prior to start of treatment. * Positive claudin 18.2 tumor expression defined as ≥50% of tumor cells demonstrating moderate-to-strong membranous staining (2+/3+) by IHC assay performed on sections of tumor derived from formalin fixed paraffin block. * Adequate organ function. * Life expectancy \>12 weeks. * Age ≥18 years. * ECOG performance status 0 or 1 at screening. * Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent. * Patients of reproductive potential: All female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before study entry. Specific criteria for Part A: * Disease progression or relapse following conventional chemotherapy: 1. Pancreatic cancer 2. Gastric cancer (including GEJ cancer) Specific criteria for Part B: * Measurable disease suitable for imaging and efficacy tracking as defined by RECIST 1.1 * Disease progression or relapse following conventional chemotherapy: 1. Pancreatic cancer 2. Gastric cancer (including GEJ cancer)
Exclusion criteria
1. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to baseline or to common terminology criteria for adverse events (CTCAE) grade ≤1, with the exception of alopecia, ≥grade 2 neuropathy, or to the levels dictated in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with dose-limiting toxicities (DLTs) during the DLT evaluation period. | through study completion, an average of 3 year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinically significant changes in vital signs | 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 clinical laboratory tests | through study completion, an average of 3 year | Number of participants with clinically significant changes in clinical laboratory tests |
| CPO102 pharmacokinetics: Area under the concentration time curve over the dosing interval. | through study completion, an average of 3 year | CPO102 pharmacokinetics: Area under the concentration time curve over the dosing interval. |
| CPO102 pharmacokinetics: Maximum concentration of the drug (Cmax) | through study completion, an average of 3 year | CPO102 pharmacokinetics: Maximum concentration of the drug (Cmax) |
| Number of participants with treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship. | through study completion, an average of 3 year | TEAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0. |
| CPO102 pharmacokinetics: Elimination half-life (t1/2) | through study completion, an average of 3 year | CPO102 pharmacokinetics: Elimination half-life (t1/2) |
| CPO102 pharmacokinetics: Clearance (CL) | through study completion, an average of 3 year | CPO102 pharmacokinetics: Clearance (CL) |
| CPO102 Objective response rate (ORR) | through study completion, an average of 3 year | 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. |
| CPO102 immunogenicity: Number of participants with anti-drug-antibody (ADA) | through study completion, an average of 3 year | CPO102 immunogenicity: Number of participants with anti-drug-antibody (ADA) |
| CPO102 pharmacokinetics: Time to maximum concentration (Tmax) | through study completion, an average of 3 year | CPO102 pharmacokinetics: Time to maximum concentration (Tmax) |
Outcome results
None listed