Intratumoral ONM-501 for Advanced Solid Tumors and Lymphomas

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.

Recruiting Phase 1 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
168 (estimated)
Sponsor
OncoNano Medicine, Inc. · Industry
Who this trial is looking for

This trial is looking for adults with advanced solid tumors or lymphomas that can't be treated with standard therapies. Participants will receive ONM-501 by injection, either alone or with another treatment called cemiplimab.

Are You a Good Fit for This Trial?
Rules you out Autoimmune diseaseHypersensitivity to ONM-501Active infection requiring treatment

You may be able to join if

  • I am at least 18 years old.
  • I have advanced solid tumors or lymphomas.
  • I have at least one tumor that can be injected.
  • I can give informed consent to participate.
  • I have had no effective treatment options left.
  • I am in good health with my liver and bone marrow function.
  • I have managed Hepatitis B or C, or HIV with treatment.

You may not be able to join if

  • I have had another active cancer in the last 2 years, except certain skin or cervical cancers.
  • I had major surgery in the last 4 weeks.
  • I have untreated brain metastases.
  • I have uncontrolled high blood pressure.
  • I am pregnant or breastfeeding.
  • I have had a major heart event in the last 6 months.
  • I have an active infection needing treatment.
  • I am part of another clinical trial.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

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.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: 1. Ability to understand and willingness to sign written informed consent before performance of any study procedures 2. Age ≥ 18 years 3. Participants with solid tumors or lymphomas, confirmed by available histopathology records or current biopsy, that are advanced, nonresectabl…
Contacts

Trials@OncoNanoMed.com

(682) 285-1411

trials@onconanomed.com

CONTACT