NCT06022029

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 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: OncoNano Medicine, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase 1, multi-center trial will consist of three parts: monotherapy dose escalation; combination therapy dose finding; and combination therapy dose expansion exploring two doses in specific tumor indication(s). Each dosing cycle of ONM-501 will be 21 days. ONM 501 will be administered as intratumoral injections once per week for three weeks (on Days 1, 8, and 15), followed by three weeks without ONM-501 administration. The monotherapy dose escalation will utilize an accelerated titration method. The combination agent will be administered according to standard protocol, once every three weeks. This phase will evaluate ONM-501 in combination with approved immune checkpoint inhibitor (ICI) cemiplimab. Enrollment in this phase will follow a "Rolling 6" or 6+0 methodology - up to 6 patients will be enrolled in a staggered format; dose escalation of ONM-501 will be permitted. Once the recommended doses for expansion (RDEs) are determined for ONM-501 + ICI combination or ONM-501 monotherapy, the expansion phase of this study will be initiated. The expansion phase will enroll patients in one to three indication-specific expansion cohorts.

Conditions

• Triple Negative Breast Cancer
• Diffuse Large B Cell Lymphoma
• Follicular Lymphoma
• Lymphoma, Non-Hodgkin
• Mantle Cell Lymphoma
• Bladder Cancer
• Uveal Melanoma, Recurrent
• Cervix Cancer
• Carcinoma in Situ
• Head and Neck Squamous Cell Carcinoma
• Skin Cancer
• Metastatic Cancer
• Tumor, Solid
• Tumor Recurrence

Interventions

Type	Name	Description
DRUG	ONM-501	Intratumoral injection
DRUG	Cemiplimab	Intravenous administration of 350 mg

Timeline

• Start date: 2023-10-13
• Primary completion: 2026-04-30
• Completion: 2026-08-29
• First posted: 2023-09-01
• Last updated: 2025-12-24

Locations

16 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study