ONM-501 and Cemiplimab for Advanced Solid Tumors and Lymphomas
This study is testing a new drug called ONM-501, given as an injection directly into the tumor (intratumoral injection). It will be studied alone and in combination with another drug, cemiplimab, which is a checkpoint inhibitor (a type of immunotherapy that helps your immune system fight cancer). This trial is for people aged 18 or older with advanced solid tumors or lymphomas, including Triple Negative Breast Cancer, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, and Mantle Cell Lymphoma, whose cancer has progressed. The main goal is to find out the safest dose of ONM-501 and to understand any side effects. About 168 people are expected to join this study.
- Study design
- This is a Phase 1, multi-center, open-label (you and your doctors will know what treatment you are receiving) study that is not randomized. It will involve about 168 participants.
- What's involved
- You would receive ONM-501 injections once a week for three weeks, followed by three weeks without the drug. If you are in the combination part of the study, cemiplimab will be given every three weeks. This treatment cycle will continue for up to approximately 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for side effects and safety for up to approximately 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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.
At a glance
Conditions
Where it's being run
16 sites across 10 statesWho to contact
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What this trial measures
- Dose Escalation and Expansion Phases: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs SeverityUp to approximately 24 months
AE incidence will be coded using Medical Dictionary for Regulatory Activities (MedDRA) terminology. AE severity will be graded according to NCI CTCAE version 5.0 or later. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living \[ADL\]); Grade 3 scales as Severe (severe or medically significant but not immediately life threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 scales as Life-threatening consequences, urgent intervention indicated, and Grade 5 scales as Death related to Adverse Event (AE)
- Dose Escalation and Expansion Phases: Number of Participants with Dose-Limiting Toxicities (DLTs)Up to approximately 24 months
DLT will be defined as the occurrence of any of the following events in the first 28 days of treatment in the dose escalation cohorts in Part 1 of the study or in the first 28 days of treatment for the first 6 patients at any dose in Part 1b (DLT observation periods). Any adverse event resulting in a dose hold or delay of ≥ 28 days will be considered a DLT. Toxicity will be evaluated according to NCI CTCAE version 5.0.
- Dose Escalation and Expansion Phases: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs)Up to approximately 24 months
AE incidence will be coded using Medical Dictionary for Regulatory Activities (MedDRA) terminology. AE severity will be graded according to NCI CTCAE version 5.0 or later.