Testing ONC-841 for advanced solid tumors

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

This study is testing a new antibody drug called ONC-841 to see if it can help people with advanced solid tumors by boosting their immune response against the cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: OncoC4, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 8 sites (Sacramento, California and 7 other locations)
• Trial ID: NCT06352359 on ClinicalTrials.gov

What this trial studies

This Phase I open-label, dose-escalation study evaluates the safety, pharmacokinetics, and efficacy of ONC-841, an investigational antibody drug, in patients with advanced or metastatic solid tumors. The study will administer ONC-841 intravenously at seven different dose levels ranging from 0.03 mg/kg to 30 mg/kg, given once every four weeks. The drug targets Siglec10 on immune cells to enhance the immune response against tumor cells by blocking signals that prevent immune cell activity. Participants will be monitored for safety and treatment response throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic solid tumors who have measurable disease and adequate organ function.

Not a fit: Patients with uncontrolled adverse events from previous cancer therapies or those with certain health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance the immune system's ability to target and eliminate advanced solid tumors.

How similar studies have performed: While this approach is novel, similar immunotherapy strategies have shown promise in other studies targeting immune modulation in cancer treatment.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Sacramento, California and 7 other locations

• University of California at Davis Cancer Center — Sacramento, California, United States (Recruiting)
• UF Health Cancer Center, University of Florida — Gainesville, Florida, United States (Recruiting)
• AdventHealth Medical Group Oncology Research at Celebration — Kissimmee, Florida, United States (Recruiting)
• Norton Cancer Center — Louisville, Kentucky, United States (Recruiting)
• Rogel Cancer Center, University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Tianhong Li, MD, PhD — University of California, Davis
• Study coordinator: Pan Zheng, MD, PhD

Conditions Advanced Solid Tumor