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Virus Therapy

ONC-841 for Cancer

Phase 1
Waitlist Available
Led By Tianhong Li, MD, PhD
Research Sponsored by OncoC4, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year.
Awards & highlights

Summary

This trial is testing a new drug called ONC-841 given through an IV to patients with advanced solid tumors. The study will test seven different doses of ONC-841, starting from a low

Who is the study for?
This trial is for adults with advanced solid tumors who are relatively fit (ECOG score ≤ 1), weigh at least 40 kg, and have proper organ function. They must have a confirmed diagnosis with measurable disease and agree to use contraception. Participants will provide consent and may need to give tissue samples.
What is being tested?
The study tests different doses of ONC-841, an intravenous drug for treating advanced solid tumors. It's an early-phase trial (Phase I) that gradually increases the dose from 0.03 mg/kg to 30 mg/kg to find the safest and most effective level.
What are the potential side effects?
As this is a Phase I trial primarily assessing safety, specific side effects of ONC-841 are not listed but may include typical reactions related to cancer drugs such as nausea, fatigue, infusion-related reactions, or changes in blood counts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity (DLT)
Maximum Toxicity Dose (MTD)
Secondary outcome measures
Cmax of ONC-841
The serum half-life of ONC-841

Trial Design

1Treatment groups
Experimental Treatment
Group I: ONC-841Experimental Treatment1 Intervention
ONC-392 will be given by IV infusion in designated dose, q4w.

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Who is running the clinical trial?

OncoC4, Inc.Lead Sponsor
6 Previous Clinical Trials
1,553 Total Patients Enrolled
Tianhong Li, MD, PhDPrincipal InvestigatorUniversity of California, Davis
1 Previous Clinical Trials
600 Total Patients Enrolled
Pan Zheng, MD, PhDStudy ChairOncoC4, Inc.
~20 spots leftby Jun 2025
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