Clinical trialPhase 1Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 10 August 2026
- Expected end
- 1 August 2028
- Enrollment
- 20 participants
- Sites
- 3
- Primary outcomes
- Recommended Phase 2 dose (RP2D)
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 8 September 2026
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.