CPI-444-001: A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose- Selection Study of CPI-444 as Single Agent and in Combination with Atezolizumab in Patients with Selected Incurable Cancers

CPI-444-001: A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose- Selection Study of CPI-444 as Single Agent and in Combination with Atezolizumab in Patients with Selected Incurable Cancers

Gender
Minimum Age
Adults
Maximum Age
Adults
Physicians
Owonikoko, Taofeek
Phases
I
Drugs
CPI-444 (1372) Atezolizumab (1376)
Disease Sites
Anus Bladder Breast - Female Colon Kidney Lip, Oral Cavity and Pharynx Lung Melanoma Prostate
Locations
Winship Cancer Institute of Emory University
NCT ID
NCT02655822
Protocol Number
CPI-444-001
Contact
If interested in learning more about this clinical trial, please contact winshipcto@emory.edu or (404) 778-1868.

Title

CPI-444-001: A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose- Selection Study of CPI-444 as Single Agent and in Combination with Atezolizumab in Patients with Selected Incurable Cancers

Summary

Primary Objective:

-To evaluate the safety and tolerability of multiple doses of CPI-444 administered on a daily schedule to subjects with selected incurable cancers as single agent and in combination with atezolizumab.

-To identify a recommended dose and schedule for further study of CPI-444 on the basis of safety, pharmacokinetic (PK), and pharmacodynamic data, to be used as single agent and in combination with atezolizumab.

  • To evaluate the anti-tumor activity of CPI-444 in subjects with incurable cancer as single agent and in combination with atezolizumab.

Secondary Objectives:

-To characterize the PK of CPI-444 in subjects with incurable cancer as single agent and in combination with atezolizumab.

-To conduct a preliminary assessment of biologic markers that might predict CPI-444 anti-tumor activity as single agent and in combination with atezolizumab.

-To explore the effects of CPI-444 on lymphocyte subsets, cytokine production, immune function and tumor immunohistochemistry, and gene expression as a single agent and in combination with atezolizumab.

Detail

Primary Objective:

-To evaluate the safety and tolerability of multiple doses of CPI-444 administered on a daily schedule to subjects with selected incurable cancers as single agent and in combination with atezolizumab.

-To identify a recommended dose and schedule for further study of CPI-444 on the basis of safety, pharmacokinetic (PK), and pharmacodynamic data, to be used as single agent and in combination with atezolizumab.

  • To evaluate the anti-tumor activity of CPI-444 in subjects with incurable cancer as single agent and in combination with atezolizumab.

Secondary Objectives:

-To characterize the PK of CPI-444 in subjects with incurable cancer as single agent and in combination with atezolizumab.

-To conduct a preliminary assessment of biologic markers that might predict CPI-444 anti-tumor activity as single agent and in combination with atezolizumab.

-To explore the effects of CPI-444 on lymphocyte subsets, cytokine production, immune function and tumor immunohistochemistry, and gene expression as a single agent and in combination with atezolizumab.

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior) Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Documented incurable cancer with one of the following histologies: non-small cell lung cancer, malignant melanoma, renal cell cancer, triple negative breast cancer, head and neck cancer, colorectal cancer with microsatellite instability (MSI), and bladder cancer. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1). At least 1 but not more than 5 prior systemic therapies for advanced/recurrent or progressing disease. Exclusion Criteria History of severe hypersensitivity reaction to monoclonal antibodies. Any active autoimmune disease or a documented history of serious autoimmune disease within the past 5 years requiring immunosuppressive therapy. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or clinical symptoms of active pneumonitis. The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited. If a patient is currently receiving denosumab, this must be discontinued prior to enrollment. Substitution with biphosphonates are acceptable.