Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
Lawrence Fong (ucsf)
Photo of Lawrence Fong
Lawrence Fong

Description

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.

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

Keywords

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 NSCLC RCC TNBC mCRPC CRC Lung Cancer Kidney Cancer Rectal Cancer Breast Cancer Endometrial Pancreatic Ovarian SCCHN NHL Endometrial Neoplasms Triple Negative Breast Neoplasms Carcinoma, Renal Cell Squamous Cell Carcinoma of Head and Neck Pembrolizumab CPI-006 CPI-006 + ciforadenant CPI-006 + pembrolizumab Cohort1b

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • City Of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist at UC Cancer

  • Lawrence Fong (ucsf)
    Lawrence Fong, M.D. is the Efim Guzik Distinguished Professor in Cancer Biology and leads the Cancer Immunotherapy Program at the UCSF. He also co-directs the Parker Institute of Cancer Immunotherapy at UCSF and co-leads the Cancer Immunity Program in the Helen Diller Family Comprehensive Cancer Center.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Corvus Pharmaceuticals, Inc.
ID
NCT03454451
Phase
Phase 1
Study Type
Interventional
Last Updated