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

  • Interventional
  • Recruiting
  • NCT03454451
Eligibility Details Visit Clinicaltrials.gov

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

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.

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. This trial is composed of dose escalation and dose expansion cohorts.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT03454451

IRB#IRB18-0462

Lead SponsorCorvus Pharmaceuticals, Inc.

Lead PhysicianWalter Stadler

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting