Clinical Trials /

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

NCT03454451

Description:

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.

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

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: CPI-006 Alone and in Combination With Ciforadenant 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 OR IN COMBINATION WITH CIFORADENANT, WITH PEMBROLIZUMAB, AND WITH CIFORADENANT PLUS 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
  • Non-hodgkin Lymphoma

Interventions

DrugSynonymsArms
CPI-006Cohort 1a
CPI-006 + ciforadenantCohort1b
CPI-006 + pembrolizumabCohort 1c
CPI-006Cohort 2a
CPI-006 + ciforadenantCohort 2b
CPI-006 + pembrolizumabCohort 2c

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1aExperimentalCPI-006
  • CPI-006
Cohort1bExperimentalCPI-006 + ciforadenant
  • CPI-006 + ciforadenant
Cohort 1cExperimentalCPI-006 + pembrolizumab
  • CPI-006 + pembrolizumab
Cohort 2aExperimentalCPI-006
  • CPI-006
Cohort 2bExperimentalCPI-006 + ciforadenant
  • CPI-006 + ciforadenant
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. For Escalation: At least 1 but not more than 5 prior systemic therapies for advanced/
             recurrent or progressing disease. For Expansion: Subject must have progressed on, be
             refractory to, or intolerant to 1-3 prior systemic therapies.

          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 ciforadenant 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 ciforadenant 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
  • NHL

Last Updated

July 27, 2021