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Testing ONM-501 alone and with Cemiplimab for 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

Phase 1 Interventional OncoNano Medicine, Inc. · NCT06022029

This study is testing a new treatment called ONM-501, both alone and with another drug called cemiplimab, to see if it can help people with advanced solid tumors and lymphomas who have run out of other treatment options.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment168 (estimated)
Ages18 Years and up
SexAll
SponsorOncoNano Medicine, Inc. Industry-sponsored
Drugs / interventionscemiplimab, prednisone
Locations16 sites (Los Angeles, California and 15 other locations)
Trial IDNCT06022029 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced, nonresectable, or recurrent solid tumors or lymphomas that have progressed after previous therapies.

Not a fit: Patients with early-stage tumors or those who have alternative standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors and lymphomas that are currently difficult to treat.

How similar studies have performed: Other studies have shown promise with similar approaches using intratumoral therapies and immune checkpoint inhibitors, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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, 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 this trial is running

Los Angeles, California and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.