Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

Running, not enrolling · Phase 1/Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04140526

Run by

OncoC4, Inc.

People needed

733

Starts

2020-09-16

Expected to finish

2027-12-31

Last updated by the study team

2025-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• . Patients must have a histological or cytological diagnosis of NSCLC or any other type of carcinoma or sarcomas, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy.
• In the Part A Phase I dose escalation study of ONC-392 monotherapy, patients with advanced/metastatic solid tumors of any histology are eligible for participation.
• Please note: tumor types of primary interest in this study are malignant melanoma, renal cell carcinoma, hepatocellular carcinoma, non-small cell lung cancer, head and neck carcinoma, gastric carcinoma, ovarian carcinoma, colorectal cancer, any type of sarcoma.
• In Part B dose finding of the ONC-392 plus pembrolizumab combination, patients with advanced/metastatic solid tumors of any histology that Pembrolizumab has been approval as standard of care are eligible for participation.
• In Part C, patients with pancreatic cancer, triple negative breast cancer, non small cell lung cancer, melanoma, Head and Neck cancer, ovarian cancer, and other solid tumors are eligible.
• In Part D, patients with recurrent and/or metastatic adenoid cystic carcinoma with disease progression within 12 months are eligible.
• Patients must have RECIST V1.1 Measurable disease:
• Patient is male or female and >18 years of age on day of signing informed consent.
• Patient must have a performance status of 0 or 1 on the ECOG Performance Scale
• Patient must have adequate organ function as indicated by the following laboratory values:
• Hematological: Absolute neutrophil count (ANC) ≥1,500 /mcL; Plateletsa ≥100,000 / mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L- without qualifications; Renal: Serum creatinine ≤1.5 X upper limit of normal (ULN); Hepatic: Serum total bilirubin ≤1.5 X ULN; OR Direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 ULN; AST (SGOT) and ALT (SGPT) ≤2.5 X ULN, OR ≤5 X ULN for patients with active liver metastases Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN
• Patient has voluntarily agreed to participate by giving written informed consent.
• Female patient of childbearing potential has a negative urine or serum pregnancy test.
• Female and Male patients must agree to use adequate methods of contraception starting with the first dose of study drug through 90 days after the last dose of study therapy.

You may not qualify if…

• A patient meeting any of the following criteria is not eligible to participate in this study:
• Patients who have not recovered to CTCAE ≤ 1 from the AE due to cancer therapeutics. The washout period for cancer therapeutic drugs (such as chemotherapy, radioactive, or targeted therapy) is 21 days, and for antibody drug 28 days.
• Patients who are currently enrolled in a clinical trial of an investigational agent or device.
• Patients who are on chronic systemic steroid therapy at doses >10 mg/day
• Patients who have active symptomatic brain metastasis or leptomeningeal metastasis.
• Patients who have an active infection requiring systemic IV therapy within 14 days of prior to administration of ONC-392 or combined ONC-392 and Pembrolizumab.
• Patients who have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
• Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Patients who are pregnant or breastfeeding.
• For the Part B and Part C Arm D to G, the patients that are deemed to be not suitable for Pembrolizumab.

Where it is running

• Highlands Oncology Group — Springdale, Arkansas, United States
• University of California at Davis — Davis, California, United States
• The Oncology Institute of Hope and Innovation — Downey, California, United States
• City of Hope Cancer Center — Duarte, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Nuvance Health — Norwalk, Connecticut, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists — Atlantis, Florida, United States
• University of Florida Health Cancer Center — Gainesville, Florida, United States
• Ocala Oncology Florida Cancer Affiliates — Ocala, Florida, United States
• AdventHealth Cancer Institute — Orlando, Florida, United States
• Memorial Cancer Institute — Pembroke Pines, Florida, United States
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States
• Norton Health — Lexington, Kentucky, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• The Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Atlantic Healthcare System — Morristown, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• The Ohio State University James Cancer Center — Columbus, Ohio, United States
• Zangmeister Cancer Center — Columbus, Ohio, United States
• Pennsylvania Cancer Specialists & Research Institute (Formerly Gettysburg Cancer Center) — Gettysburg, Pennsylvania, United States

Full record on ClinicalTrials.gov

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