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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: Recruiting Phase 1 study of Bladder Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by OncoNano Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AE incidence will be coded using Medical Dictionary for Regulatory Activities (MedDRA) terminology. AE severity will be graded according to NCI CTCAE version 5.0 or later. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living \[ADL\]); Grade 3 scales as Severe (severe or medically
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 |
What NCT06022029 shows while recruiting
NCT06022029 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower).
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 lists 16 locations in 10 states (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.
Learn More About Clinical Trials
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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 NCT06022029's enrollment target sits among peer trials
168 64th of 175 higher than 112 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer 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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