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

NCT06352359 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ONC-841-002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 8

Brief Summary

This is a Phase I/II open label study of intravenous (IV) infusion of ONC-841 as a single agent or in combination in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841. The Phase 1 part is dose escalation with 7 dose levels of ONC-841 and the dose expansion in the last dose level. The Phase 2 part will test the combination of ONC-841 with SOC in GBM and in CRC.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT)

  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.

  28 Days

• Maximum Toxicity Dose (MTD)

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

  28 Days

Secondary Outcomes (2)

• Cmax of ONC-841

  84 days

• The serum half-life of ONC-841

  84 days

Study Arms (1)

ONC-841

EXPERIMENTAL

ONC-841 will be given by IV infusion in designated dose, q4w.

Drug: ONC-841

Interventions

ONC-841 DRUG

ONC-841 (anti-SIGLEC10) is a humanized antibody that binds to human sialic acid-binding Ig-like lectin 10 and has a human immunoglobulin G4 (IgG4) Fc domain.

Also known as: Anti-SIGLEC10 antibody

ONC-841

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• OncoC4, Inc.: lead

Study Sites (8)

University of California at Davis Cancer Center

Sacramento, California, 95817, United States

RECRUITING

UF Health Cancer Center, University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

AdventHealth Medical Group Oncology Research at Celebration

Kissimmee, Florida, 34747, United States

RECRUITING

Norton Cancer Center

Louisville, Kentucky, 40202, United States

RECRUITING

Rogel Cancer Center, University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 770360, United States

RECRUITING

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

NOT YET RECRUITING

Study Officials

• Tianhong Li, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pan Zheng, MD, PhD

CONTACT

(240) 552-5193; pzheng@oncoc4.com

Imaan Khan, MD

CONTACT

ikhan@oncoc4.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)