Intratumoral ONM-501 for Advanced Solid Tumors and Lymphomas
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.
Recruiting
Phase 1Interventional Study
Triple Negative Breast CancerDiffuse Large B Cell LymphomaFollicular LymphomaLymphoma, Non-HodgkinMantle Cell LymphomaBladder CancerUveal Melanoma, RecurrentCervix CancerCarcinoma in SituHead and Neck Squamous Cell CarcinomaSkin CancerMetastatic CancerTumor, SolidTumor Recurrence
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
168 (estimated)
Sponsor
OncoNano Medicine, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with advanced solid tumors or lymphomas that can't be treated with standard therapies. Participants will receive ONM-501 by injection, either alone or with another treatment called cemiplimab.
Are You a Good Fit for This Trial?
Rules you outAutoimmune diseaseHypersensitivity to ONM-501Active infection requiring treatment
You may be able to join if
I am at least 18 years old.
I have advanced solid tumors or lymphomas.
I have at least one tumor that can be injected.
I can give informed consent to participate.
I have had no effective treatment options left.
I am in good health with my liver and bone marrow function.
I have managed Hepatitis B or C, or HIV with treatment.
You may not be able to join if
I have had another active cancer in the last 2 years, except certain skin or cervical cancers.
I had major surgery in the last 4 weeks.
I have untreated brain metastases.
I have uncontrolled high blood pressure.
I am pregnant or breastfeeding.
I have had a major heart event in the last 6 months.
I have an active infection needing treatment.
I am part of another clinical trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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, nonresectabl…
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
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