RecruitingPhase 1NCT06022029

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


Sponsor

OncoNano Medicine, Inc.

Enrollment

168 participants

Start Date

Oct 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial tests a new drug called ONM-501 — injected directly into tumors — alone and in combination with the immunotherapy drug cemiplimab, in people with advanced solid tumors or lymphomas that have stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older with an advanced solid tumor or lymphoma that has progressed on standard therapies - You have at least one tumor that can be injected and measured - Your liver, kidney, and blood function are adequate - You have HIV but are on stable antiretroviral therapy with controlled viral levels **You may NOT be eligible if...** - You had another cancer within the past 2 years (excluding certain minor skin cancers or cervical carcinoma in situ) - You had major surgery within 4 weeks - You have uncontrolled high blood pressure or recent major cardiovascular events - You are pregnant or breastfeeding - You have active infection requiring treatment or are on another clinical trial - You have untreated brain metastases or tumors near the brainstem or meninges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGONM-501

Intratumoral injection

DRUGCemiplimab

Intravenous administration of 350 mg


Locations(16)

California Research Institute

Los Angeles, California, United States

BRCR Global

Tamarac, Florida, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Cancer Care Wollongong

Wollongong, New South Wales, Australia

University of the Sunshine Coast Clinical Trials

Buderim, Queensland, Australia

Tasman Oncology Research

Southport, Queensland, Australia

Princess Alexandra Hospital | Metro South Health

Woolloongabba, Queensland, Australia

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, Australia

St John of God Subiaco Hospital

Subiaco, Western Australia, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06022029


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