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Brief Title: 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


  • Org Study ID: ON-5001
  • Secondary ID: N/A
  • NCT ID: NCT06022029
  • Sponsor: OncoNano Medicine, Inc.


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.


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.

  • Overall Status
  • Start Date
    October 13, 2023
  • Phase
    Phase 1
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • 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


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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact


Phone: (682) 285-1411



Facility Status Contact
Facility: BRCR Global
Tamarac, Florida 33321
United States
Status: Recruiting Contact: Contact
Isabela Vazquez

Principal Investigator
Chintan Gandhi, MD

Facility: Ohio State University
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Contact
Allison Reynolds

Principal Investigator
Joal Beane, MD

Facility: Allegheny Health Network
Pittsburgh, Pennsylvania 15224
United States
Status: Recruiting Contact: Contact
Shelly A Evans, MBA, BS, RN

Principal Investigator
Patrick Wagner, MD

Facility: UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: Contact
Barb Stadterman

Principal Investigator
Liza Villaruz, MD

Facility: University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Heather McArthur, MD

Principal Investigator
Heather McArthur

Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Hebah Elbahy

Principal Investigator
Sarina A. Piha-Paul, MD