Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Tianhong Li, MD (ucdavis)

Description

Summary

This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.

Official Title

Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)

Details

Keywords

Non Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Melanoma, Metastatic Head and Neck Carcinoma, Metastatic Renal Cell Carcinoma, Metastatic Colorectal Cancer, Sarcomas, Metastatic Prostate Cancer, Ovarian Cancer, Small Cell Lung Cancer, Metastatic Breast Cancer, Pancreas Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Junction Adenocarcinoma, Cervical Cancer, Adenoid Cystic Carcinoma, Salivary Gland Cancer, Urothelial Carcinoma, Carcinoma, Lung Neoplasms, Small Cell Lung Carcinoma, Salivary Gland Neoplasms, Pancreatic Neoplasms, Pembrolizumab, Docetaxel, ONC-392, ONC-392 and docetaxel

Eligibility

Locations

  • University of California at Davis accepting new patients
    Davis California 95817 United States
  • The Oncology Institute of Hope and Innovation accepting new patients
    Downey California 90241 United States
  • City of Hope Cancer Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Tianhong Li, MD (ucdavis)
    Professor, MED: Int Med Hematology/Oncology, School of Medicine. Authored (or co-authored) 65 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
OncoC4, Inc.
ID
NCT04140526
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 733 study participants
Last Updated