Testing ONM-501 alone and with Cemiplimab for advanced solid tumors and lymphomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, multicenter trial aims to determine the maximum tolerated dose and recommended dose for expansion of intratumoral ONM-501, both as a standalone treatment and in combination with the PD-1 checkpoint inhibitor cemiplimab. The study consists of three parts: dose escalation for monotherapy, dose finding for combination therapy, and an expansion phase for specific tumor types. Patients will receive ONM-501 through intratumoral injections over a 21-day cycle, while cemiplimab will be administered according to standard protocols. The trial will enroll patients with advanced solid tumors and lymphomas who have no alternative standard therapy options.

Why it matters

Who can join: the full rules

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

Where it's running

• St Vincent's Hospital
  Darlinghurst, New South Wales, Australia Recruiting
• Cancer Care Wollongong
  Wollongong, New South Wales, Australia Recruiting
• University of the Sunshine Coast Clinical Trials
  Buderim, Queensland, Australia Recruiting
• Tasman Oncology Research
  Southport, Queensland, Australia Recruiting
• Princess Alexandra Hospital | Metro South Health
  Woolloongabba, Queensland, Australia Recruiting
• California Research Institute
  Los Angeles, California, United States Active not recruiting

Study contacts

• Study coordinator: Trials@OncoNanoMed.com
• Email: trials@onconanomed.com
• Phone: (682) 285-1411

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.