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

Phase 1

Completed

• Conditions: Cervical Cancer; Ovarian Cancer; Non-Small Cell Lung Cancer; Colorectal Cancer; Sarcoma; Renal Cell Cancer; Bladder Cancer; Triple Negative Breast Cancer; Pancreatic Cancer; Endometrial Cancer
• Interventions: Drug: CPI-006; Drug: CPI-006 + ciforadenant; Drug: CPI-006 + pembrolizumab

• Registration Number: NCT03454451
• Lead Sponsor: Corvus Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-06
• Study Start: 2018-04-25
• Primary Completion: 2022-12-28
• Study Completion: 2023-02-19
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
2. Documented incurable cancer with one of the following histologies: nonsmall cell lung cancer, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability(MSI), bladder cancer, cervical cancer, uterine cancer, sarcoma, endometrial cancer, and metastatic castration resistant prostate cancer.
3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
4. For Escalation: At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease. For Expansion: Subject must have progressed on, be refractory to, or intolerant to 1-3 prior systemic therapies.
5. Willingness to provide tumor biopsies.

Exclusion Criteria

1. History of severe hypersensitivity reaction to monoclonal antibodies.
2. Subjects who have received prior therapy with regimens containing cytotoxicT-lymphocyte antigen-4 (CTLA-4), programmed cell death ligand 1 (PDL1), or PD1 antagonists are NOT permitted to enroll unless all adverse events (AEs) while receiving prior immunotherapy have resolved to Grade 1 or baseline prior to screening.
3. History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.
4. The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
5. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1a	CPI-006	CPI-006
Cohort1b	CPI-006 + ciforadenant	CPI-006 + ciforadenant
Cohort 2b	CPI-006 + ciforadenant	CPI-006 + ciforadenant
Cohort 2c	CPI-006 + pembrolizumab	CPI-006 + pembrolizumab
Cohort 1c	CPI-006 + pembrolizumab	CPI-006 + pembrolizumab
Cohort 2a	CPI-006	CPI-006

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.	From start of treatment to end of treatment, up to 36 months
Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.	From start of treatment to end of treatment, up to 36 months
Identify the MDL(maximum dose level) of single agent CPI-006	From start of treatment to end of treatment, up to 36 months

Secondary Outcome Measures

Name	Time	Method
Area under the curve (AUC) of CPI-006	Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Objective response rate per RECIST v.1.1 criteria of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.	From start of treatment to end of treatment, up to 36 months
Maximum serum concentration (Cmax) of CPI-006	Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).

Trial Locations

Locations (27)

Arizona Oncology; 🇺🇸 Tucson, Arizona, United States

City Of Hope; 🇺🇸 Duarte, California, United States

UC San Francisco; 🇺🇸 San Francisco, California, United States

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

The University of Chicago; 🇺🇸 Chicago, Illinois, United States

The John Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Dana Farber; 🇺🇸 Boston, Massachusetts, United States

Comprehensive Cancer Centers of Nevada; 🇺🇸 Las Vegas, Nevada, United States

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