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.
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests ONM-501 injected into a tumor, alone or with cemiplimab, to find safe doses that may work. It is for adults with advanced solid tumors or lymphoma, a cancer of the immune system, who have no standard treatment options left.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Understand the study and agree in writing before any study procedures.
- Have cancer confirmed by tissue testing that is advanced, cannot be removed by surgery, or has returned. It must be growing since the last cancer treatment, with no standard treatment option left.
- Have at least one tumor that can be measured and injected.
- Have bone marrow that works well enough to make blood cells.
- Have liver function that meets study requirements.
- Past hepatitis B or C is allowed if your liver works well enough.
- If you have HIV, be on established HIV treatment for at least 4 weeks, with a virus level below 400 copies/mL and a CD4 immune cell count of at least 350 cells/uL.
Who can't join
- Another cancer active in the past 2 years, except certain skin, bladder, cervical, or breast cancers treated to cure them.
- Major surgery in the past 4 weeks, or a major heart or blood vessel event in the past 6 months.
- Cancer spread to the brain that is untreated, in the lower back part of the brain, or in its lining. Some other brain tumors may be allowed with sponsor approval.
- A heart rhythm test showing a QTc interval over 470 milliseconds when blood mineral levels are normal, or high blood pressure that is not well controlled.
- Being pregnant or breastfeeding, or being able to become pregnant but refusing highly effective birth control.
- Recent experimental treatment within 4 weeks or the time it takes for the drug level to fall by half five times, whichever is shorter; or taking part in another treatment trial.
- An active infection needing medicine that treats the whole body, or an allergy to any ingredient in ONM-501.
- For ONM-501 plus cemiplimab: an allergy to cemiplimab ingredients; an active or recent disease where the immune system attacks the body; a recent illness needing whole-body steroids above 10 mg daily of prednisone or an equal dose; or a condition needing whole-body steroid treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (9)
CA
- California Research Institute · Los Angeles, CA 90027More trials in Los Angeles
FL
- BRCR Global · Tamarac, FL 33321More trials in Tamarac
OH
- Gabrail Cancer Center Research · Canton, OH 44718More trials in Canton
- Ohio State University · Columbus, OH 43210More trials in Columbus
PA
- Allegheny Health Network · Pittsburgh, PA 15224More trials in Pittsburgh
- UPMC Hillman Cancer Center · Pittsburgh, PA 15232More trials in Pittsburgh
TX
- University of Texas Southwestern Medical Center · Dallas, TX 75390More trials in Dallas
- MD Anderson Cancer Center · Houston, TX 77030More trials in Houston
VA
- Virginia Cancer Specialists, PC · Fairfax, VA 22031More trials in Fairfax