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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. — ON-5001  

Bladder Cancer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Bladder Cancer
  • Carcinoma
  • Carcinoma in Situ
  • Cervix Cancer
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • Head and Neck Squamous Cell Carcinoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Mantle Cell Lymphoma
  • Melanoma
  • Metastatic Cancer
  • Neoplasms
  • Recurrence
  • Skin Cancer
  • Skin Neoplasms
  • Squamous Cell Carcinoma of Head and Neck
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
  • Tumor Recurrence
  • Tumor, Solid
  • Urinary Bladder Neoplasms
  • Uterine Cervical Neoplasms
Clinical Trial Details
NCT number NCT06022029
Study type Interventional
Source OncoNano Medicine, Inc.
Contact Trials@OncoNanoMed.com
Phone (682) 285-1411
Email trials@onconanomed.com
Status Recruiting
Phase Phase 1
Start date October 13, 2023
Completion date August 29, 2026
View Details
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