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Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers

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ClinicalTrials.gov Identifier: NCT02655822
Recruitment Status : Recruiting
First Posted : January 14, 2016
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Corvus Pharmaceuticals, Inc.

Brief Summary:
This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Malignant Melanoma Renal Cell Cancer Triple Negative Breast Cancer Colorectal Cancer Bladder Cancer Metastatic Castration Resistant Prostate Cancer Drug: CPI-444 Drug: CPI-444 + atezolizumab Phase 1

Detailed Description:
This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as a single agent and in combination with atezolizumab, an intravenous PD-L1 inhibitor. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of CPI-444 as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers
Study Start Date : January 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Cohort 1
CPI-444
Drug: CPI-444
100 mg orally twice daily for the first 14 days of each 28-day cycle.
Experimental: Cohort 2
CPI-444
Drug: CPI-444
100 mg orally twice daily for 28 days of each 28-day cycle.
Experimental: Cohort 3
CPI-444
Drug: CPI-444
200 mg orally once daily for the first 14 days of each 28-day cycle.
Experimental: Cohort 4
CPI-444 + atezolizumab
Drug: CPI-444 + atezolizumab
CPI-444 orally in combination with atezolizumab intravenously.
Experimental: Cohort 5
CPI-444
Drug: CPI-444
Start with150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.



Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities (DLTs) of CPI-444 as a single agent and in combination with atezolizumab [ Time Frame: 28 days following first administration of CPI-444 ]
  2. Objective response rate per RECIST v1.1 criteria of CPI-444 as a single agent and in combination with atezolizumab [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
  3. Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.4.03, of CPI-444 as a single agent and in combination with atezolizumab [ Time Frame: Continuously, up to 36 months ]
  4. Mean and median Area under the curve (AUC) of CPI-444 [ Time Frame: Day 14 of Cycle 1 ]
  5. Mean and median Maximum concentration (Cmax) of CPI-444 [ Time Frame: Day 14 of Cycle 1 ]
  6. Identify the MDL (maximum dose level) of single agent CPI-444 [ 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, Senior)
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: non-small cell lung cancer, malignant melanoma, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability (MSI), bladder 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.

Exclusion Criteria

  1. History of severe hypersensitivity reaction to monoclonal antibodies.
  2. Any active autoimmune disease or a documented history of serious autoimmune disease within the past 5 years requiring immunosuppressive therapy.
  3. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or clinical symptoms of active pneumonitis.
  4. The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
  5. If a patient is currently receiving denosumab, this must be discontinued prior to enrollment. Substitution with biphosphonates are acceptable.

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): NCT02655822


Contacts
Contact: Director, Clinical Operations 650-900-4520 inquiry@corvuspharma.com

  Show 35 Study Locations
Sponsors and Collaborators
Corvus Pharmaceuticals, Inc.
Genentech, Inc.
Investigators
Study Director: C Clark Corvus Pharmaceuticals

Responsible Party: Corvus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02655822     History of Changes
Other Study ID Numbers: CPI-444-001
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Corvus Pharmaceuticals, Inc.:
NSCLC
MEL
RCC
TNBC
Triple Negative Breast Neoplasms
Neoplasms
CRC
Lung Cancer
Kidney Cancer
Colon Cancer
Rectal Cancer
Skin Cancer
Breast Cancer
mCRPC
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Urinary Bladder Neoplasms
Carcinoma, Renal Cell
Triple Negative Breast Neoplasms
Melanoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Urologic Neoplasms
Urinary Bladder Diseases