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.

Last updated: March 18, 2025
Sponsor: OncoNano Medicine, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Melanoma

Skin Cancer

Bladder Cancer

Treatment

ONM-501

Cemiplimab

Clinical Study ID

NCT06022029
ON-5001
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Ability to understand and willingness to sign written informed consent beforeperformance of any study procedures

  2. Age ≥ 18 years

  3. Participants with solid tumors or lymphomas, confirmed by available histopathologyrecords or current biopsy, that are advanced, nonresectable, or recurrent andprogressing since last antitumor therapy, and for which no alternative standardtherapy 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 liverfunction

  6. Participants with human immunodeficiency virus (HIV) are eligible if on establishedHAART for a minimum of 4 weeks prior to enrollment, have an HIV viral load <400copies/mL, and have CD4+ T-cell (CD4+) counts ≥ 350 cells/uL

  7. Adequate bone marrow function:

  8. Adequate liver function

Exclusion

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 squamouscell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix orbreast 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 themeninges. Participants with stable or previously treated progressing brainmetastases (except in the posterior fossa or involving the meninges) may bepermitted in a case-by-case basis at the Sponsor's discretion.

  4. Prolongation of corrected QT (QTc) interval to >470 millisecond (ms) for males andfemales 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 ofcontraception.

  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 4weeks 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. Hasknown 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 orrecent history of a syndrome that required systemic corticosteroids (>10 mg dailyprednisone equivalent)

  3. Has a condition requiring systemic treatment with corticosteroids

Study Design

Total Participants: 168
Treatment Group(s): 2
Primary Treatment: ONM-501
Phase: 1
Study Start date:
October 13, 2023
Estimated Completion Date:
August 29, 2026

Study 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.

Connect with a study center

  • St Vincent's Hospital

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Cancer Care Wollongong

    Wollongong, New South Wales 2500
    Australia

    Active - Recruiting

  • University of the Sunshine Coast Clinical Trials

    Buderim, Queensland 4556
    Australia

    Active - Recruiting

  • Tasman Oncology Research

    Southport, Queensland 4215
    Australia

    Active - Recruiting

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia
    Australia

    Active - Recruiting

  • St John of God Subiaco Hospital

    Subiaco, Western Australia 6008
    Australia

    Site Not Available

  • California Research Institute

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • BRCR Global

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Gabrail Cancer Center Research

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Allegheny Health Network

    Pittsburg, Pennsylvania 15224
    United States

    Site Not Available

  • Allegheny Health Network

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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