Clinical trialPhase 1Withdrawn
Dose Escalation and Expansion Study of CPO102, an Anti-claudin 18.2 ADC in Patients With Advanced Cancers
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
- Outcome
- Stopped earlyNew IND sponsor to initiate a separate study (Business decision)
- Phase
- Phase 1
- Status
- Withdrawn
- Study type
- Interventional
- Start
- 16 November 2022
- Expected end
- 16 November 2022
- Enrollment
- 0 participants
- Sites
- 0
- Primary outcomes
- Number of participants with dose-limiting toxicities (DLTs) during the DLT evaluation period.
- Sponsor
- Industry
- Results posted
- No
- Last update
- 7 September 2023
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.