Clinical Trials /

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

NCT03454451

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 and Non-Hodgkin lymphoma.

Related Conditions:
  • Bladder Carcinoma
  • Breast Carcinoma
  • Cervical Carcinoma
  • Colorectal Carcinoma
  • Endometrial Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Prostate Carcinoma
  • Renal Cell Carcinoma
  • Sarcoma
  • Uterine Corpus Carcinosarcoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: CPI-006 Alone and in Combination With CPI-444 and With Pembrolizumab for Patients With Advanced Cancers
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CPI-006-001
  • NCT ID: NCT03454451

Conditions

  • 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

Interventions

DrugSynonymsArms
CPI-006Cohort 1a
CPI-006 + CPI-444Cohort1b
CPI-006 + pembrolizumabCohort 1c
CPI-006Cohort 2a
CPI-006 + CPI-444Cohort 2b
CPI-006 + pembrolizumabCohort 2c

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1aExperimentalCPI-006
  • CPI-006
Cohort1bExperimentalCPI-006 + CPI-444
  • CPI-006 + CPI-444
Cohort 1cExperimentalCPI-006 + pembrolizumab
  • CPI-006 + pembrolizumab
Cohort 2aExperimentalCPI-006
  • CPI-006
Cohort 2bExperimentalCPI-006 + CPI-444
  • CPI-006 + CPI-444
Cohort 2cExperimentalCPI-006 + pembrolizumab
  • CPI-006 + pembrolizumab

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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).
Safety Issue:
Description:
Measure:Maximum serum concentration (Cmax) of CPI-006
Time Frame:Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Corvus Pharmaceuticals, Inc.

Trial Keywords

  • NSCLC
  • RCC
  • TNBC
  • mCRPC
  • CRC
  • Lung Cancer
  • Kidney Cancer
  • Rectal Cancer
  • Breast Cancer
  • Sarcoma
  • Endometrial
  • Pancreatic
  • Ovarian
  • SCCHN

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