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ONC-841 for Advanced Solid Tumors

This study is testing a new drug called ONC-841 for people with advanced solid tumors (cancers that have spread or are hard to treat). ONC-841 is an antibody drug that works by helping your immune system's cells, like macrophages and neutrophils, "eat" cancer cells. The study will look at the safety and how well ONC-841 works when given alone, and later, in combination with standard treatments for certain cancers. To join, you must have a solid tumor that has spread or is locally advanced, be at least 18 years old, and have good overall health and organ function. The main goals are to find the safest dose and understand any side effects within the first 28 days.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 72 participants and will test seven different dose levels of ONC-841.
What's involved
You will receive ONC-841 through an IV (into a vein) once every four weeks. The study will evaluate your response and any side effects.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for safety and dose are measured at 28 days after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06352359

Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
OncoC4, Inc.
~72 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:ONC-841

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Limiting Toxicity (DLT)
Measured over 28 Days
+1 more outcome measured

Conditions

Advanced Solid Tumor

Explore related trials

Solid Neoplasm

NCT06352359

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AdventHealth Medical Group Oncology Research at Celebration

    Kissimmee, Floridano site contact published

    Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utahno site contact published

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasno site contact published

    Recruiting

  • Norton Cancer Center

    Louisville, Kentuckyno site contact published

    Recruiting

  • Rogel Cancer Center, University of Michigan

    Ann Arbor, Michiganno site contact published

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvaniano site contact published

    Recruiting

  • UF Health Cancer Center, University of Florida

    Gainesville, Floridano site contact published

    Recruiting

  • University of California at Davis Cancer Center

    Sacramento, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tianhong Li, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, Davis

Who to contact

Pan Zheng, MD, PhD
[email protected]
(240) 552-5193
Email the study team

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Eligibility criteria

Inclusion

Must have ECOG score ≤ 1. The body weight should be ≥40 kg.
A histological or cytological diagnosis of solid tumors and metastatic disease or locally advanced disease.
Must have measurable target lesion according to RECIST V1.1.
Adequate organ function as determined by laboratory tests.
Voluntary agreement to participate as evidenced by written informed consent.
Female patient: negative pregnancy test and agreement on contraceptive methods.
Male patient: agreement on contraceptive methods.
Agree to give archival or other diagnostic tissue recut slides or an optional new tumor biopsy.

Exclusion

Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled endocrine immune-related AEs are considered stable and eligible for enrollment.
The washout period for cancer therapeutic drugs should be 5 half-life or 21 days for chemotherapy, whichever is shorter; or 28 days for monoclonal antibody therapy. Palliative radiotherapy for painful metastases or metastases in potentially sensitive locations (e.g., epidural space) ≥ 7 days prior to the first dose of study drug. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, blood transfusion and therapy for non-cancer conditions are allowed.
Patients who are currently enrolled in any other clinical trial testing an investigational agent or device, or with concurrent anticancer treatment (except palliative bone-directed radiotherapy), immune therapy, or cytokine therapy or anticipated to require another antineoplastic therapy during the study.
Patients who are on chronic systemic steroid therapy at doses higher than 10 mg/day prednisone or equivalent within 7 days before first treatment.
Patients who have active brain metastases or leptomeningeal metastases. Patients who have active brain metastases or leptomeningeal metastases. Patients are eligible if brain metastases are adequately treated, and patients are asymptomatic or neurologically stable (except for residual signs or symptoms related to the central nervous system (CNS) treatment). Note: Patients with previously treated brain metastases may participate provided they are radiologically stable (i.e. no evidence of progression for ≥4 weeks by repeat imaging performed during study screening), clinically stable, and not requiring steroid treatment within 14 days before the first dose of study treatment.
Patient with a different cancer other than the one treated under this protocol, which requires systemic treatments within 24 months prior to C1D1.
Patient has history of grade ≥3 allergic or hypersensitivity to IV infusion medications, or severe allergic reactions to food, pollen, oral medications, or atopic dermatitis or asthmatic episodes that required hospitalization.
Within past 6 months with history of significant cardiovascular acute myocardial infarction, acute coronary syndrome, ischemic or hemorrhagic stroke, revascularization procedures, acute pulmonary embolism or any disorders resulted in LVEF \< 40% at the time of screening or colitis, small bowel obstruction, hepatitis or pancreatitis adrenal insufficiency, or severe immunotherapy related AE (irAE≥ grade 3).
Patients who have acute infections which require systemic treatments within 14 days prior to C1D1.
Patients who, in the opinion of the treating Investigator, 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 make study participation not in the best interest of the patient, in the opinion of the treating Investigator. Investigators should discuss the case with the Sponsor and/or study leaders.
Patients with known psychiatric or substance abuse disorders may interfere with cooperation with the requirements of the trial.
Patients who are pregnant or breastfeeding or plan pregnancy or fathering the child during the study or within 6 months after the last dosing of study drug

What this trial measures

  • Dose Limiting Toxicity (DLT)28 Days

    The number of subjects who have Dose limiting toxicity (DLT) as defined by protocol DLT criteria during the first cycle of study drug, ONC-841, administration.

  • Maximum Toxicity Dose (MTD)28 Days

    Maximal tolerable dose (MTD), the study drug, ONC-841, dose level that has two out of six subjects who have DLT.