NCT03454451

CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers

A PHASE 1/1b MULTICENTER STUDY TO EVALUATE THE HUMANIZED ANTI-CD73 ANTIBODY, CPI-006, AS A SINGLE AGENT OR IN COMBINATION WITH CIFORADENANT, WITH PEMBROLIZUMAB, AND WITH CIFORADENANT PLUS PEMBROLIZUMAB IN ADULT SUBJECTS WITH ADVANCED CANCERS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Corvus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/1b open-label, dose escalation and dose expansion study of CPI-006, a humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult subjects with select advanced cancers. CPI-006 will be evaluated as a single agent, in combination with ciforadenant (an oral adenosine 2A receptor antagonist), in combination with pembrolizumab (an anti-PD1 antibody), and in combination with ciforadenant and pembrolizumab.

Conditions

• Non-Small Cell Lung Cancer
• Renal Cell Cancer
• Colorectal Cancer
• Triple Negative Breast Cancer
• Cervical Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Endometrial Cancer
• Sarcoma
• Squamous Cell Carcinoma of the Head and Neck
• Bladder Cancer
• Metastatic Castration Resistant Prostate Cancer
• Non-hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	CPI-006	Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression.
DRUG	CPI-006 + ciforadenant	Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression.
DRUG	CPI-006 + pembrolizumab	Subjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression.
DRUG	CPI-006	Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.
DRUG	CPI-006 + ciforadenant	Selected dose of CPI-006 administered intravenously once every 21 days, in combination with CPI-444 orally twice daily until disease progression.
DRUG	CPI-006 + pembrolizumab	Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.

Timeline

• Start date: 2018-04-25
• Primary completion: 2022-12-28
• Completion: 2023-02-19
• First posted: 2018-03-06
• Last updated: 2023-12-21

Locations

27 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study