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

NOT ENROLLING
Protocol # :
18-335
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
Phase
I
Disease Sites
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Wei, Xiao, Xiao
Site Investigator
Gainor, Justin
McDermott, David, F.
Site Research Nurses
Baylies, Rosemarie
Carey, Margaret, M.
Gillen Mckay, Christine, A.
Gotthardt, Susan, Jean
Kelley, Kristina
Rang, Bethany

Trial 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.

Eligibility Requirements

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.

18-335