Triple Negative Breast Cancer study: ONM-501 vs Cemiplimab
Official 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.
ClinicalTrials.gov ID: NCT06022029
What this study is testing
What is ONM-501?
ONM-501 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for triple negative breast cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the highest safe dose, the lowest dose that shows effect, and the best dose to use in later trials of ONM-501 given into tumors, both alone and with a PD‑1 blocker.
- Who it's for
- Adults who have advanced solid tumors or lymphomas that have come back or spread.
- What's involved
- Participants receive injections of ONM-501 directly into a tumor, may also receive the drug cemiplimab, and undergo regular clinic visits for safety checks, scans and lab tests.
- Time commitment
- The trial runs for several months with multiple visits, including dosing visits and follow‑up assessments.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to understand and willingness to sign written informed consent before performance of any study procedures
- Age ≥ 18 years
- Participants with solid tumors or lymphomas, confirmed by available histopathology records or current biopsy, that are advanced, nonresectable, or...
- Participants must have a minimum of one injectable and measurable lesion.
- Participants with prior Hepatitis B or C are eligible if they have adequate liver function
You likely can't join if
- Other malignancy active within the previous 2 years except for basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ...
- Major surgery within 4 weeks before the first dose of study drug.
- Brain metastases that are untreated or in the posterior fossa or involve the meninges.
- Prolongation of corrected QT (QTc) interval to \>470 millisecond (ms) for males and females when electrolytes balance is normal.
- Females who are breastfeeding or pregnant at screening or baseline
- Females of childbearing potential that refuse to use a highly effective method of contraception.
See the full eligibility criteria
- Ability to understand and willingness to sign written informed consent before performance of any study procedures
- Age ≥ 18 years
- 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...
- Participants must have a minimum of one injectable and measurable lesion.
- Participants with prior Hepatitis B or C are eligible if they have adequate liver function
- 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...
- Adequate liver function
- 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.
- Major surgery within 4 weeks before the first dose of study drug.
- 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...
- Prolongation of corrected QT (QTc) interval to \>470 millisecond (ms) for males and females when electrolytes balance is normal.
- Females who are breastfeeding or pregnant at screening or baseline
- Females of childbearing potential that refuse to use a highly effective method of contraception.
- 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...
- 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
- Has an active infection requiring systemic treatment
- Is participating in another therapeutic clinical trial Additional Exclusion Criteria for ONM-501 in Combination with cemiplimab (Part 1b)
- Has known hypersensitivity to any component in the formulation of cemiplimab
- 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)
- Has a condition requiring systemic treatment with corticosteroids
The study team makes the final eligibility decision.
Where it is enrolling
- Darlinghurst, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Buderim, Queensland, Australia
- Southport, Queensland, Australia
- Woolloongabba, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Darlinghurst, New South Wales, Australia; Wollongong, New South Wales, Australia; Buderim, Queensland, Australia; Southport, Queensland, Australia; Woolloongabba, Queensland, Australia. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.