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Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors

A Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors

NCT07408258•OncoC4, Inc.

View on ClinicalTrials.gov

Summary

ONC-783-001 is a Phase I open label, dose-escalation study for evaluating the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer.

Detailed Description

This is a first in human study on a novel bispecific antibody, ONC-783, targeting cancer specific neoantigen CD24 on tumor cells and CD3 on T cells. CD24 is over-expressed in about 70% of solid tumors and hematological malignancies. CD24 overexpression is associated with poor prognosis. Cancer-specific neo-CD24 epitope will distinguish malignant CD24 from physiological CD24. This study is a multi-level dose escalation study with ONC-783 to test the safety, PK, and efficacy in patients with solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•Patient with a different cancer other than the one treated under this protocol, which requires systemic treatments within 24 months prior to C1D1.
+6 more criteria

Exclusion Criteria

•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.

Locations (2)

Columbia University Medical Center

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

June 1, 2026

Primary Completion Date

June 1, 2027

Completion Date

June 1, 2028

Last Updated

February 13, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Solid Tumor

Interventions

ONC-783

DRUG

Contacts

Pan Zheng, MD, PhD

CONTACT

(202) 751-6823 pzheng@oncoc4.com

Yao Wang, MD, MS

CONTACT

(973) 873-8678 ywang@oncoc4.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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