ONC-783 for Advanced Solid Tumors
This study is testing a new drug called ONC-783 for people with advanced solid tumors, specifically pancreatic, ovarian, colorectal, or breast cancer. ONC-783 is a bispecific humanized monoclonal antibody, which means it's an engineered protein designed to target specific features on cancer cells (CD24) and immune cells (CD3) to fight the cancer. The main goal is to find the safest and most effective dose of ONC-783. You may be able to join if you are at least 18 years old, have a good general health score (ECOG score ≤ 1), and your cancer can be measured. The study is currently unclear on its recruitment status and plans to enroll 20 participants.
- Study design
- This is a first-in-human, open-label study to test different doses of ONC-783 in about 20 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, Recommended Phase 2 dose (RP2D), is measured at 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07408258
Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentOncoC4, Inc.
~20 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:ONC-783
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase 2 dose (RP2D)
Measured over 24 Months
Conditions
Where it's being run
2 sites across 2 statesNew York1
Texas1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age ≥ 18 yrs old.
Male or Female
Must have ECOG score ≤ 1. The body weight should be ≥40 kg. The life expectance should be estimated ≥ 12 weeks.
A histological or cytological diagnosis of metastatic or locally advanced pancreatic cancer, ovarian cancer, colorectal cancer, or breast cancer.
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 of childbearing potential: negative pregnancy test and agreement on highly effective contraceptive methods.
Male patient: agreement on contraceptive methods.
Exclusion
Patients who have not recovered to NCI CTCAE Grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the Grade ≤ 2 chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled Grade ≤ 2 endocrine immune-related AEs are considered stable and eligible for enrollment.
The washout period for cancer therapeutic drugs (such as chemotherapy, radiation or targeted therapy) is 21 days 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 is allowed. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, growth factors 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 are eligible if brain metastases are adequately treated or not felt to require local treatment (i.e. \< 10 mm asymptomatic) 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 that they are radiologically stable, 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 SC injected medications, or severe allergic reactions to food, pollen, oral medications, or atopic dermatitis or asthmatic episodes that required hospitalization.
QTcF (QT interval corrected for heart rate using Fridericia formula) \>480 msec on screening ECG
Within past 6 months with history of significant cardiovascular events including acute myocardial infarction, acute coronary syndrome, ischemic or hemorrhagic stroke, heart failure NYHA class III or IV, or revascularization procedures.
Patients who have acute infections which require systemic IV drug treatments within 7 days prior to C1D1. Oral drug or prophylaxis treatment is allowed.
Patients who, in the opinion of the treating Investigator, have a history or current evidence of any medical or psychiatric conditions that would limit their ability to comply with all aspects of the trial or on a therapy, or with a significant 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. Investigators should discuss the case with the Sponsor.
Patients who are pregnant or breastfeeding, or who intend to become pregnant or father a child during the study or within 6 months after the last dosing of study drug.
What this trial measures
- Recommended Phase 2 dose (RP2D)24 Months
Recommended Phase 2 dose of the study drug ONC-783