NCT04853329

Dose Escalation and Expansion Study of CPO107 for Patients With Advanced CD20-positive Non-Hodgkins Lymphoma

Phase 1/2, Multicenter, First-In-Human, Dose Escalation and Dose Expansion Study of CPO107 Administered Intravenously to Patients With Advanced CD20-positive Non-Hodgkins Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Conjupro Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This first-in-human Phase 1 study will be a multicenter, dose-escalating, single-agent study conducted in patients with advanced CD20-associated hematological cancers for which the investigator determines there to be no other higher priority therapies available.

Detailed description

This first-in-human Phase 1 study will be a multicenter, dose-escalating, single-agent study conducted in patients with advanced CD20-associated hematological cancers for which the investigator determines there to be no other higher priority therapies available. All patients must have failed at least two prior lines of conventional systemic therapy that must also include an approved CD20 based treatment. All patients will need to have CD20-positive disease, as determined by the expression of CD20 on tumor cells assayed within 6 months prior to study entry. The study will consist of 2 parts, Part A and Part B. In Part A of the study, dose escalation will proceed according to the guidelines in the Treatment and Dosing section below, following a rule-based design methodology. Two different schedules will be explored to establish the PK profile and thus better inform the selection of the final dosing schedule to be developed. Arm A will explore a continuous weekly dosing schedule and will commence first. Arm B will explore a 3 weekly schedule in which a single dose is administered every 3 weeks. Part B dose expansion of the study will commence, in which a single dosing schedule will be explored in CD20-positive patients. The schedule will be selected based on PK and safety determinants from Study Part A. NOTE: Trial was intended to be a Phase 1/2 trial, however the trial only enrolled patients in Study Part A (Phase 1) and was subsequently terminated early for business reasons.

Conditions

• CD20 Positive Non Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	CPO107	CD20-CD47 Bispecific Fusion Protein

Timeline

• Start date: 2021-12-13
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2021-04-21
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study