ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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.

January 8, 2016
January 14, 2016
April 5, 2018
January 2016
June 2018   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
  • 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 ]
  • Mean and median Area under the curve (AUC) of CPI-444 [ Time Frame: Day 14 of Cycle 1 ]
  • Mean and median Maximum concentration (Cmax) of CPI-444 [ Time Frame: Day 14 of Cycle 1 ]
  • 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. ]
  • 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 ]
  • 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 24 months ]
  • 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 24 months ]
  • Mean and median Area under the curve (AUC) of CPI-444 [ Time Frame: Day 14 of Cycle 1 ]
  • Mean and median Maximum concentration (Cmax) of CPI-444 [ Time Frame: Day 14 of Cycle 1 ]
Complete list of historical versions of study NCT02655822 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers
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
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
    100 mg orally twice daily for the first 14 days of each 28-day cycle.
  • Drug: CPI-444
    100 mg orally twice daily for 28 days of each 28-day cycle.
  • Drug: CPI-444
    200 mg orally once daily for the first 14 days of each 28-day cycle.
  • Drug: CPI-444 + atezolizumab
    CPI-444 orally in combination with atezolizumab intravenously.
  • Drug: CPI-444
    Start with150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.
  • Experimental: Cohort 1
    CPI-444
    Intervention: Drug: CPI-444
  • Experimental: Cohort 2
    CPI-444
    Intervention: Drug: CPI-444
  • Experimental: Cohort 3
    CPI-444
    Intervention: Drug: CPI-444
  • Experimental: Cohort 4
    CPI-444 + atezolizumab
    Intervention: Drug: CPI-444 + atezolizumab
  • Experimental: Cohort 5
    CPI-444
    Intervention: Drug: CPI-444
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
534
Same as current
December 2018
June 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Director, Clinical Operations 650-900-4520 inquiry@corvuspharma.com
Australia,   Canada,   United States
 
 
NCT02655822
CPI-444-001
Yes
Not Provided
Not Provided
Corvus Pharmaceuticals, Inc.
Corvus Pharmaceuticals, Inc.
Genentech, Inc.
Study Director: C Clark Corvus Pharmaceuticals
Corvus Pharmaceuticals, Inc.
April 2018

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