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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
Led by OncoNano Medicine, Inc. · Updated on 2025-12-24
168
Participants Needed
16
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ONM-501, a drug given as intratumoral injections, alone and in combination with cemiplimab, an immune checkpoint inhibitor, in patients with advanced solid tumors and lymphomas. This phase 1 study aims to find the maximum tolerated dose, minimum effective dose, and recommended dose for expansion of ONM-501. The study includes patients with various advanced cancers who have no alternative standard therapies available. The trial has three parts monotherapy dose escalation, combination therapy dose finding, and combination therapy dose expansion. ONM-501 is given once per week for three weeks followed by three weeks off, in 21-day cycles. Cemiplimab is given intravenously every three weeks during the combination phases. Dose escalation uses special methods to gradually increase doses, and after doses are established, patients will enroll in expansion cohorts for specific tumor types. Participants will have regular assessments including monitoring for side effects, blood tests to measure drug levels, and evaluation of tumor response over up to 24 months. Researchers will track treatment-emergent adverse events, dose-limiting toxicities, and serious adverse events. Outcomes such as objective response rate, duration of response, progression-free survival, and overall survival will also be recorded. The study involves close safety monitoring and follow-up throughout the treatment and observation periods.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent before any study procedures
- Age 18 years or older
- Diagnosed with advanced, nonresectable, or recurrent solid tumors or lymphomas progressing after last therapy, with no alternative standard treatment
- Have at least one injectable and measurable lesion
- Prior Hepatitis B or C patients allowed if liver function adequate
- HIV patients allowed if on stable treatment with viral load <400 copies/mL and CD4 counts ≥350 cells/uL
- Adequate bone marrow and liver function
You will not qualify if you...
- Active malignancy within last 2 years except certain skin cancers, superficial bladder cancer, or carcinoma in situ that completed curative therapy
- Major surgery within 4 weeks before first dose
- Untreated brain metastases or brain tumors involving meninges; some stable or treated brain metastases may be allowed
- QTc interval >470 ms with normal electrolytes
- Pregnant or breastfeeding women
- Females of childbearing potential not using highly effective contraception
- Uncontrolled or poorly controlled hypertension
- Prior investigational therapy within 5 half-lives or 4 weeks before study drug
- Major cardiovascular event within 6 months before study drug
- Known hypersensitivity to ONM-501 or cemiplimab (for combination phase)
- Active infection requiring systemic treatment
- Participation in another therapeutic clinical trial
- History of autoimmune disease or recent corticosteroid treatment (for combination phase)
- Conditions requiring systemic corticosteroids (for combination phase)
Research Team
T
Trials@OncoNanoMed.com
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