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CPI-006 Alone and in Combination With CPI-444 and With Pembrolizumab for Patients With Advanced Cancers

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ClinicalTrials.gov Identifier: NCT03454451
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Corvus Pharmaceuticals, Inc.

Brief Summary:
This is a phase 1/1b open label, multicenter, dose-selection study of CPI-006, a Type 2 humanized IgG1 antibody inhibiting enzymatic activity of CD73 and adenosine production. This trial will study the safety, tolerability, and anti-tumor activity of CPI-006 as a single agent, in combination with CPI-444, a small molecule targeting the adenosine-A2A receptor on immune cells, and in combination with pembrolizumab, an anti-PD1 antibody against various solid tumors.

Condition or disease Intervention/treatment Phase
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 Drug: CPI-006 Drug: CPI-006 + CPI-444 Drug: CPI-006 + pembrolizumab Phase 1

Detailed Description:
This is a phase 1/1b open label, multicenter, dose-selection study of CPI-006, a Type 2 humanized IgG1 antibody inhibiting enzymatic activity of CD73 and adenosine production. This trial will study the safety, tolerability, and anti-tumor activity of CPI-006 as a single agent, in combination with CPI-444, a small molecule targeting the adenosine-A2A receptor on immune cells, and in combination with pembrolizumab, an anti-PD1 antibody against various solid tumors. This trial is composed of dose escalation and dose expansion cohorts.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Multicenter Study To Evaluate The Humanized Anti-CD73 Antibody, CPI-006, As A Single Agent, In Combination With CPI-444, And In Combination With Pembrolizumab In Adult Subjects With Advanced Cancers
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2023


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 + CPI-444
Drug: CPI-006 + CPI-444
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 + CPI-444
Drug: CPI-006 + CPI-444
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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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). ]
  2. Maximum serum concentration (Cmax) of CPI-006 [ Time Frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). ]
  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454451


Locations
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Contact: Site Coordinator    203-785-3482    ycci@yale.edu   
Principal Investigator: Patricia LoRusso, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Study Coordinator    305-243-0865    txl351@med.miami.edu   
Principal Investigator: Jaime Merchan, MD         
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Site Coordinator    773-702-1835    mweist@medicine.bsd.uchicago.edu   
Principal Investigator: Jason Luke, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Site Coordinator    212-824-7309    ccto@mssm.edu   
Principal Investigator: Thomas Marron, MD         
United States, North Carolina
Carolina BioOncology Institute Recruiting
Huntsville, North Carolina, United States, 28078
Contact: Study Coordinator    704-947-6599    info@carolinabiooncology.org   
Principal Investigator: John Powderly         
United States, Oklahoma
University of Oklahoma - Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Coordinator    405-271-1112    SCC-Clinical-Trials-Office@ouhsc.edu   
Principal Investigator: Abhishek Tripathi, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Site Coordinator    615-329-7274    asksarah@sarahcannon.com   
Principal Investigator: Melissa Johnson, MD         
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: Study Coordinator    972-566-3000    information@marycrowley.org   
Principal Investigator: Minal Barve, MD         
United States, Wisconsin
Froedtert Hospital & Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Coordinator    414-805-8900    CCCTO@mcw.edu   
Principal Investigator: Matthew Riese, MD         
Sponsors and Collaborators
Corvus Pharmaceuticals, Inc.
Investigators
Study Director: G Luciano Corvus Pharmaceuticals

Responsible Party: Corvus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03454451     History of Changes
Other Study ID Numbers: CPI-006-001
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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

Keywords provided by Corvus Pharmaceuticals, Inc.:
NSCLC
RCC
TNBC
mCRPC
CRC
Lung Cancer
Kidney Cancer
Rectal Cancer
Breast Cancer
Sarcoma
Endometrial
Pancreatic
Ovarian
SCCHN

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Carcinoma, Squamous Cell
Pancreatic Neoplasms
Sarcoma
Uterine Cervical Neoplasms
Urinary Bladder Neoplasms
Endometrial Neoplasms
Carcinoma, Renal Cell
Prostatic Neoplasms
Triple Negative Breast Neoplasms
Head and Neck Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma