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Dose Escalation and Expansion Study of CPO102, an Anti-claudin 18.2 ADC in Patients With Advanced Cancers

Pancreatic Cancer Clinical Trial

Official title:
A Phase 1, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate Safety of CPO102, an Anti-claudin 18.2 Antibody-MMAE Drug Conjugate Administered Intravenously in Patients With Advanced Pancreatic and Gastric Cancers

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05043987
Study type Interventional
Source Conjupro Biotherapeutics, Inc.
Contact
Status Withdrawn
Phase Phase 1
Start date November 16, 2022
Completion date November 16, 2022
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