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NCT06022029 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.
A Phase 1 study of Bladder Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by OncoNano Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 168
- Enrollment target
- 16
- Study locations
NCT06022029 is a Phase 1 study of Bladder Cancer and Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by OncoNano Medicine. The registered enrollment target is 168 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The trial reports 16 study locations across 10 states.
The verdict
NCT06022029, a Phase 1 study of Bladder Cancer and Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by OncoNano Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 168 participants
- Enrollment target
- 16
- Study locations
Study Summary
A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and/or recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas.
Conditions Studied
Interventions
- DRUG ONM-501
- DRUG Cemiplimab
Study Locations (16)
Queensland
- University of the Sunshine Coast Clinical Trials - Buderim
- Tasman Oncology Research - Southport
- Princess Alexandra Hospital | Metro South Health - Woolloongabba
Ohio
- Gabrail Cancer Center Research - Canton
- Ohio State University - Columbus
Pennsylvania
- Allegheny Health Network - Pittsburgh
- UPMC Hillman Cancer Center - Pittsburgh
Texas
- University of Texas Southwestern Medical Center - Dallas
- MD Anderson Cancer Center - Houston
New South Wales
- St Vincent's Hospital - Darlinghurst
- Cancer Care Wollongong - Wollongong
California
- California Research Institute - Los Angeles
Florida
- BRCR Global - Tamarac
Virginia
- Virginia Cancer Specialists, PC - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2023-10-13 |
| Est. Completion | 2026-08-29 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06022029
The ClinicalTrials.gov registry entry for NCT06022029 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The listed sponsor is OncoNano Medicine, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which ONM-501 is the first listed.
NCT06022029 reports 16 study locations spanning 10 distinct geographic areas - top geographies include Queensland, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06022029 about?
NCT06022029 is a clinical study titled "A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.". A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and/or recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibito...
What is the current status of trial NCT06022029?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 168 participants. The study started on 2023-10-13. Estimated completion is 2026-08-29.
What conditions does trial NCT06022029 study?
This clinical trial studies the following conditions: Bladder Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma.
What interventions are being tested in trial NCT06022029?
The interventions under investigation include: ONM-501 (DRUG), Cemiplimab (DRUG).
Who is sponsoring clinical trial NCT06022029?
This trial is sponsored by OncoNano Medicine, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06022029 being conducted?
This trial has 16 study locations across California, Florida, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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