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

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ClinicalTrials.gov Identifier: NCT03454451

Recruitment Status : Active, not recruiting

First Posted : March 6, 2018

Last Update Posted : August 3, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Corvus Pharmaceuticals, Inc.

Tracking Information

First Submitted Date ^ICMJE

February 5, 2018

First Posted Date ^ICMJE

March 6, 2018

Last Update Posted Date

August 3, 2022

Actual Study Start Date ^ICMJE

April 25, 2018

Estimated Primary Completion Date

December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab. [ Time Frame: 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. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
Identify the MDL(maximum dose level) of single agent CPI-006 [ Time Frame: From start of treatment to end of treatment, up to 36 months ]

Original Primary Outcome Measures ^ICMJE

Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with CPI-444 and with pembrolizumab. [ Time Frame: 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 CPI-444 and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
Identify the MDL(maximum dose level) of single agent CPI-006 [ Time Frame: From start of treatment to end of treatment, up to 36 months ]

Change History

Current Secondary Outcome Measures ^ICMJE

Area under the curve (AUC) of CPI-006 [ Time Frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). ]
Maximum serum concentration (Cmax) of CPI-006 [ Time Frame: 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. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]

Original Secondary Outcome Measures ^ICMJE

Area under the curve (AUC) of CPI-006 [ Time Frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). ]
Maximum serum concentration (Cmax) of CPI-006 [ Time Frame: 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 CPI-444 and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

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.

Study Arms ^ICMJE

Experimental: Cohort 1a
CPI-006

Intervention: Drug: CPI-006
Experimental: Cohort1b
CPI-006 + ciforadenant

Intervention: Drug: CPI-006 + ciforadenant
Experimental: Cohort 1c
CPI-006 + pembrolizumab

Intervention: Drug: CPI-006 + pembrolizumab
Experimental: Cohort 2a
CPI-006

Intervention: Drug: CPI-006
Experimental: Cohort 2b
CPI-006 + ciforadenant

Intervention: Drug: CPI-006 + ciforadenant
Experimental: Cohort 2c
CPI-006 + pembrolizumab

Intervention: Drug: CPI-006 + pembrolizumab

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

378

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 2025

Estimated Primary Completion Date

December 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
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.
At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
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.
Willingness to provide tumor biopsies.

Exclusion Criteria

History of severe hypersensitivity reaction to monoclonal antibodies.
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.
History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.
The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03454451

Other Study ID Numbers ^ICMJE

CPI-006-001

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Corvus Pharmaceuticals, Inc.

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Corvus Pharmaceuticals, Inc.

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

S Mahabhashyam, MD

Corvus Pharmaceuticals

PRS Account

Corvus Pharmaceuticals, Inc.

Verification Date

April 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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