New antibody aims to preserve immune checkpoint while fighting cancer
NCT ID NCT04140526
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing an experimental antibody called ONC-392 in people with advanced solid tumors, including non-small cell lung cancer and melanoma. The trial gives ONC-392 alone or with pembrolizumab, an approved immunotherapy, to see what doses are safe and how the body processes the drug. Participants receive intravenous infusions every three or four weeks. The study also looks for early signs that the treatment shrinks tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ONC-392, an experimental antibody that targets the CTLA4 immune checkpoint, given alone and with pembrolizumab
- What this could lead to
- If it works, ONC-392 could offer another way to boost the immune system against several advanced cancers, possibly with fewer immune-related side effects than existing CTLA4 drugs.
- What could go wrong
- This is an early-phase trial, so researchers mainly want to find safe doses. The drug may not shrink tumors, may cause immune-related side effects, and any benefit seen in a small group may not hold in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 733 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. . 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. 1. 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. 2. 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. 3. 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. 4. In Part D, patients with recurrent and/or metastatic adenoid cystic carcinoma with disease progression within 12 months are eligible. 5. Patients must have RECIST V1.1 Measurable disease: 2. Patient is male or female and \>18 years of age on day of signing informed consent. 3. Patient must have a performance status of 0 or 1 on the ECOG Performance Scale 4. 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 5. Patient has voluntarily agreed to participate by giving written informed consent. 6. Female patient of childbearing potential has a negative urine or serum pregnancy test. 7. 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. Exclusion Criteria: A patient meeting any of the following criteria is not eligible to participate in this study: 1. 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. 2. Patients who are currently enrolled in a clinical trial of an investigational agent or device. 3. Patients who are on chronic systemic steroid therapy at doses \>10 mg/day 4. Patients who have active symptomatic brain metastasis or leptomeningeal metastasis. 5. 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. 6. 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. 7. Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 8. Patients who are pregnant or breastfeeding. 9. For the Part B and Part C Arm D to G, the patients that are deemed to be not suitable for Pembrolizumab.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AdventHealth Cancer Institute
Orlando, Florida, 32804, United States
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Atlantic Healthcare System
Morristown, New Jersey, 07960, United States
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Cancer Research SA
Adelaide, South Australia, 5000, Australia
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City of Hope Cancer Center
Duarte, California, 91010, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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Florida Cancer Specialists
Atlantis, Florida, 33462, United States
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Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
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Highlands Oncology Group
Springdale, Arkansas, 72762, United States
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Houston Methodist Cancer Center
Houston, Texas, 77030, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02215, United States
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MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
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Memorial Cancer Institute
Pembroke Pines, Florida, 33028, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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NEXT/Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
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Newcastle Private Hospital
New Lambton Heights, New South Wales, 2305, Australia
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Norton Health
Lexington, Kentucky, 40202, United States
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Nuvance Health
Norwalk, Connecticut, 06856, United States
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Ocala Oncology Florida Cancer Affiliates
Ocala, Florida, 34474, United States
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Oncology Consultants
Houston, Texas, 77030, United States
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Pennsylvania Cancer Specialists & Research Institute (Formerly Gettysburg Cancer Center)
Gettysburg, Pennsylvania, 17325, United States
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Prisma Health
Greenville, South Carolina, 29605, United States
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Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042, Australia
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Tasman Oncology Research
Southport, Queensland, 4120, Australia
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Tennessee Oncology - Nashville
Nashville, Tennessee, 37203, United States
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Tennessee Oncology Chattanooga Memorial Plaza
Chattanooga, Tennessee, 37404, United States
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The Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
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The Ohio State University James Cancer Center
Columbus, Ohio, 43210, United States
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The Oncology Institute of Hope and Innovation
Downey, California, 90241, United States
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University of California at Davis
Davis, California, 95817, United States
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University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
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University of Colorado Hospital
Aurora, Colorado, 80045, United States
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University of Florida Health Cancer Center
Gainesville, Florida, 32610, United States
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University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
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University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
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University of Washington / Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
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Zangmeister Cancer Center
Columbus, Ohio, 43219, United States
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