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

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

INTRODUCTION

  • Org Study ID: CPI-006-001
  • Secondary ID: N/A
  • NTC ID: NCT03454451
  • Sponsor: Corvus Pharmaceuticals, Inc.

BRIEF SUMMARY

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.

  • Overall Status
    Recruiting
  • Start Date
    April 25, 2018
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.

Primary Outcome 1 - Timeframe: From start of treatment to end of treatment, up to 36 months

Primary Outcome 2 - Measure: Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.

Primary Outcome 2 - Timeframe: From start of treatment to end of treatment, up to 36 months

Primary Outcome 3 - Measure: Identify the MDL(maximum dose level) of single agent CPI-006

Primary Outcome 3 - Timeframe: From start of treatment to end of treatment, up to 36 months

CONDITION

  • 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

ELIGIBILITY

Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

- 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.

- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

- 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.

- Willingness to provide tumor biopsies.
Exclusion Criteria
History of severe hypersensitivity reaction to monoclonal antibodies.

- 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.

- History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.

- The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.

- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: S Mahabhashyam, MD

Role: Study Chair

Affiliation: Corvus Pharmaceuticals

Overall Contact

Name: S Mahabhashyam, MD

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact