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NCT06352359 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumor, sponsored by OncoC4.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 8
- Study locations
NCT06352359: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by OncoC4.
NCT06352359 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by OncoC4. The registered enrollment target is 30 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (84% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06352359, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by OncoC4.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is a Phase I open label, dose-escalation study of intravenous (IV) infusion of ONC-841 as a single agent in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841 starting from 0.03 mg/kg to 30 mg/kg.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG ONC-841
Study Locations (8)
Florida
- UF Health Cancer Center, University of Florida - Gainesville
- AdventHealth Medical Group Oncology Research at Celebration - Kissimmee
Texas
- MD Anderson Cancer Center - Houston
- Tranquil Clinical Research - Houston
California
- University of California at Davis Cancer Center - Sacramento
Kentucky
- Norton Cancer Center - Louisville
Michigan
- Rogel Cancer Center, University of Michigan - Ann Arbor
Utah
- Huntsman Cancer Institute, University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-08-23 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
What NCT06352359 shows while recruiting
NCT06352359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which ONC-841 is the first listed.
NCT06352359 lists 8 locations in 6 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT06352359 about?
NCT06352359 is a clinical study titled "Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors". This is a Phase I open label, dose-escalation study of intravenous (IV) infusion of ONC-841 as a single agent in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841 starting from 0.03 mg/kg to 30 mg/kg.
What is the current status of trial NCT06352359?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-08-23. Estimated completion is 2027-09-30.
What conditions does trial NCT06352359 study?
This clinical trial studies the following conditions: Advanced Solid Tumor.
What interventions are being tested in trial NCT06352359?
The interventions under investigation include: ONC-841 (DRUG).
Who is sponsoring clinical trial NCT06352359?
This trial is sponsored by OncoC4, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06352359 being conducted?
This trial has 8 study locations across California, Florida, Kentucky, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06352359's enrollment target sits among peer trials
30 176th of 189 higher than 14 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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