Recruiting
Phase 1

ONM-501 & Cemiplimab

Sponsor:

OncoNano Medicine, Inc.

Code:

NCT06022029

Conditions

Triple Negative Breast Cancer

Diffuse Large B Cell Lymphoma

Follicular Lymphoma

Lymphoma, Non-Hodgkin

Mantle Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ONM-501

Cemiplimab

Study Details

Brief 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.

Conditions

Triple Negative Breast Cancer

Diffuse Large B Cell Lymphoma

Follicular Lymphoma

Lymphoma, Non-Hodgkin

Mantle Cell Lymphoma

Study ID

NCT06022029

Start date

Oct 13, 2023

Status verified date

Mar, 2025

Completion date

Aug 29, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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, nonresectable, or recurrent and progressing since last antitumor therapy, and for which no alternative standard therapy exists.
4. Participants must have a minimum of one injectable and measurable lesion.
5. Participants with prior Hepatitis B or C are eligible if they have adequate liver function
6. Participants with human immunodeficiency virus (HIV) are eligible if on established HAART for a minimum of 4 weeks prior to enrollment, have an HIV viral load <400 copies/mL, and have CD4+ T-cell (CD4+) counts ≥ 350 cells/uL
7. Adequate bone marrow function:
8. Adequate liver function

Exclusion Criteria: Patients will be excluded from this study if they meet any of the following criteria (Part 1a and Part 1b).

1. Other malignancy active within the previous 2 years except for basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy.
2. Major surgery within 4 weeks before the first dose of study drug.
3. Brain metastases that are untreated or in the posterior fossa or involve the meninges. Participants with stable or previously treated progressing brain metastases (except in the posterior fossa or involving the meninges) may be permitted in a case-by-case basis at the Sponsor's discretion.
4. Prolongation of corrected QT (QTc) interval to >470 millisecond (ms) for males and females when electrolytes balance is normal.
5. Females who are breastfeeding or pregnant at screening or baseline
6. Females of childbearing potential that refuse to use a highly effective method of contraception.
7. Has uncontrolled or poorly controlled hypertension as defined by a sustained BP > 9. Has received prior investigational therapy within 5 half-lives of the agent or 4 weeks before the first administration of study drug, whichever is shorter.
8. Has had any major cardiovascular event within 6 months prior to study drug 10. Has known hypersensitivity to any component in the formulation of ONM-501
9. Has an active infection requiring systemic treatment
10. Is participating in another therapeutic clinical trial

Additional Exclusion Criteria for ONM-501 in Combination with cemiplimab (Part 1b)

1. Has known hypersensitivity to any component in the formulation of cemiplimab
2. Has any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (>10 mg daily prednisone equivalent)
3. Has a condition requiring systemic treatment with corticosteroids

Study Design

Enrollment

168 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1a: Monotherapy Dose Escalation

ONM-501 will be administered as intratumoral injections once per week for three weeks, followed by three weeks without ONM-501 administration. Each dosing cycle will be 21 days.

experimental: Part 1b: ONM-501 in Combination with cemiplimab

ONM-501 will be administered as intratumoral injections once per week for three weeks followed by three weeks without ONM-501 administration. Each dosing cycle will be 21 days. The combination agent will be administered according to standard protocol, once every three weeks.

experimental: Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohorts

Once the recommended doses for expansion (RDEs) are determined for ONM-501 + ICI combination or ONM-501 monotherapy, the expansion phase of the study will be initiated. The expansion phase will enroll patients in one to three indication-specific expansion cohorts.

Interventions

ONM-501

Intratumoral injection

Cemiplimab

Intravenous administration of 350 mg

Primary outcome measure

  • Dose Escalation and Expansion Phases: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity [ Time Frame: Up to approximately 24 months ]
  • Dose Escalation and Expansion Phases: Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 24 months ]
  • Dose Escalation and Expansion Phases: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs) [ Time Frame: Up to approximately 24 months ]

Central Contacts and Locations

Central contacts

Locations

California Research Institute

Recruiting

Los Angeles, California, United States, 90027

Contacts

Clare Gregorio

cg@caresinst.com

Principal Investigator:

Ghassan Al-Jazayrly, MD

Gabrail Cancer Center Research

Recruiting

Canton, Ohio, United States, 44718

Contacts

Principal Investigator:

Nashat Y Gabrail, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Joal Beane, MD

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Shelly A Evans, MBA, BS, RN

724-612-2931Shelly.evans@ahn.org

Principal Investigator:

Patrick Wagner, MD

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Principal Investigator:

Julia Foldi, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Heather McArthur

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Sarina A. Piha-Paul, MD

Virginia Cancer Specialists, PC

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Carrie Friedman, RN, BSN, OCN

703-636-1473carrie.friedman@usoncology.com

Principal Investigator:

Alexander Spira, MD

More Information

Sponsor

OncoNano Medicine, Inc.

Last update posted

Mar 21, 2025

Last verified

Mar, 2025

Keywords

  • Solid tumors
  • Lymphoma
  • ONM-501
  • STING
  • Intra-tumoral
  • HNSCC
  • Breast Cancer
  • Melanoma
  • Skin Cancer
  • cemiplimab
  • Libtayo
  • DLBCL
  • bladder cancer
  • cervical cancer
  • metastases
  • immunotherapy
  • ICI
  • TNBC
  • Triple Negative
  • mTNBC
  • anti-PD-1 antibody
  • BRCA1
  • BRCA2
  • anti-PD-L1
  • uveal
  • NHL
  • Mantle Zone lymphoma
  • FL
  • stimulator of interferon genes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by OncoNano Medicine, Inc. on 2025-03-21.