CPI-006 Alone And In Combination With Ciforadenant And With Pembrolizumab For Patients With Advanced Cancers

Study Overview

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

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.

N/A

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

DRUG: CPI-006
DRUG: CPI-006 + ciforadenant
DRUG: CPI-006 + pembrolizumab
DRUG: CPI-006
DRUG: CPI-006 + ciforadenant
DRUG: CPI-006 + pembrolizumab

CPI-006-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-02-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-12-19
First Submitted that Met QC Criteria 2018-03-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-12-21
First Posted (ACTUAL) 2018-03-06	Results First Posted N/A	Last Verified 2023-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cohort 1a CPI-006	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.
EXPERIMENTAL: Cohort1b CPI-006 + ciforadenant	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.
EXPERIMENTAL: Cohort 1c CPI-006 + pembrolizumab	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.
EXPERIMENTAL: Cohort 2a CPI-006	DRUG: CPI-006 Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.
EXPERIMENTAL: Cohort 2b CPI-006 + ciforadenant	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.
EXPERIMENTAL: Cohort 2c CPI-006 + pembrolizumab	DRUG: CPI-006 + pembrolizumab Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.

Primary Outcome Measures	Measure Description	Time Frame
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	Measure Description	Time Frame
Area under the curve (AUC) of CPI-006		Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Maximum serum concentration (Cmax) 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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: S Mahabhashyam, MD, Corvus Pharmaceuticals

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record