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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06022029
Registration number
NCT06022029
Ethics application status
Date submitted
15/08/2023
Date registered
1/09/2023
Date last updated
25/03/2025
Titles & IDs
Public 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.
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Scientific title
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
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Secondary ID [1]
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ON-5001
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Universal Trial Number (UTN)
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Trial acronym
ON-5001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer
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Diffuse Large B Cell Lymphoma
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Follicular Lymphoma
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Lymphoma, Non-Hodgkin
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Mantle Cell Lymphoma
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Bladder Cancer
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Uveal Melanoma, Recurrent
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Cervix Cancer
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Carcinoma in Situ
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Head and Neck Squamous Cell Carcinoma
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Skin Cancer
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Metastatic Cancer
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Tumor, Solid
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Tumor Recurrence
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Malignant melanoma
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Cancer
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Bladder - transitional cell cancer
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Cancer
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Breast
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Cancer
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Head and neck
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Cancer
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Cervical (cervix)
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Cancer
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Womb (Uterine or endometrial cancer)
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ONM-501
Treatment: Drugs - Cemiplimab
Experimental: Part 1a: Monotherapy Dose Escalation - ONM-501 will be administered as intratumoral injections once per week for three weeks, followed by three weeks without ONM-501 administration. Each dosing cycle will be 21 days.
Experimental: Part 1b: ONM-501 in Combination with cemiplimab - ONM-501 will be administered as intratumoral injections once per week for three weeks followed by three weeks without ONM-501 administration. Each dosing cycle will be 21 days. The combination agent will be administered according to standard protocol, once every three weeks.
Experimental: Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohorts - Once the recommended doses for expansion (RDEs) are determined for ONM-501 + ICI combination or ONM-501 monotherapy, the expansion phase of the study will be initiated. The expansion phase will enroll patients in one to three indication-specific expansion cohorts.
Treatment: Drugs: ONM-501
Intratumoral injection
Treatment: Drugs: Cemiplimab
Intravenous administration of 350 mg
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dose Escalation and Expansion Phases: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity
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Assessment method [1]
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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)
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Timepoint [1]
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Up to approximately 24 months
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Primary outcome [2]
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Dose Escalation and Expansion Phases: Number of Participants with Dose-Limiting Toxicities (DLTs)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 24 months
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Primary outcome [3]
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Dose Escalation and Expansion Phases: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 24 months
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Secondary outcome [1]
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Dose Escalation and Expansion Phases: Cmax
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Assessment method [1]
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Cmax is defined as the Maximum Observed Plasma Concentration for ONM-501
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Timepoint [1]
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Dose Escalation and Expansion Phases: Cycle 1 Day 1 and Cycle 1 Day 8 (each cycle is 21 days): predose and at multiple timepoints (up to 24 hours).
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Secondary outcome [2]
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Dose Escalation and Expansion Phases: t1/2z
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Assessment method [2]
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t1/2z is defined as the Terminal Disposition Phase Half-life for ONM-501
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Timepoint [2]
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Dose Escalation and Expansion Phases: Cycle 1 Day 1 and Cycle 1 Day 8 (each cycle is 21 days): predose and at multiple timepoints (up to 24 hours).
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Secondary outcome [3]
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Dose Escalation and Expansion Phases: Tmax
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Assessment method [3]
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Tmax is defined as the Time to Reach the Maximum Plasma Concentration (Cmax) for ONM-501
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Timepoint [3]
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Dose Escalation and Expansion Phases: Cycle 1 Day 1 and Cycle 1 Day 8 (each cycle is 21 days): predose and at multiple timepoints (up to 24 hours).
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Secondary outcome [4]
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Dose Escalation and Expansion Phases: AUCt
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Assessment method [4]
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AUCt is defined as the Area Under the Concentration-time Curve from Time 0 to Time t for ONM-501
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Timepoint [4]
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Dose Escalation and Expansion Phases: Cycle 1 Day 1 and Cycle 1 Day 8 (each cycle is 21 days): predose and at multiple timepoints (up to 24 hours).
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Secondary outcome [5]
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Dose Escalation and Expansion Phases: AUCinf
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Assessment method [5]
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AUCinf is defined as the Area Under the Concentration-time Curve from Time 0 to Infinity for ONM-501
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Timepoint [5]
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Dose Escalation and Expansion Phases: Cycle 1 Day 1 and Cycle 1 Day 8 (each cycle is 21 days): predose and at multiple timepoints (up to 24 hours).
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Secondary outcome [6]
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Dose Escalation and Expansion Phases: CL/F
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Assessment method [6]
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CL/F is defined as the apparent clearance of ONM-501 (CL/F), where F is the fraction of the dose absorbed.
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Timepoint [6]
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Dose Escalation and Expansion Phases: Cycle 1 Day 1 and Cycle 1 Day 8 (each cycle is 21 days): predose and at multiple timepoints (up to 24 hours).
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Secondary outcome [7]
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Dose Escalation and Expansion Phases: Vz/F
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Assessment method [7]
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Vz/F is defined as the apparent volume of distribution of ONM-501 (CL/F), where F is the fraction of the dose absorbed.
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Timepoint [7]
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Dose Escalation and Expansion Phases: Cycle 1 Day 1 and Cycle 1 Day 8 (each cycle is 21 days): predose and at multiple timepoints (up to 24 hours).
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Secondary outcome [8]
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Expansion Phase Only: Objective Response Rate (ORR)
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Assessment method [8]
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Objective response will be defined as a best response of CR or PR. The objective response rate (ORR) will be calculated as the proportion of patients in the Efficacy Analysis Set who achieve an objective response. ORR will be assessed based on Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Characterize the plasma pharmacokinetics (PK) of IT ONM-501 as monotherapy and in combination with cemiplimab Evaluate additional measures of clinical benefit including: Duration of Response (DOR), Progression Free Survival (PFS) by RECIST and Overall Survival
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Timepoint [8]
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Up to approximately 24 months
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Secondary outcome [9]
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Expansion Phase Only: Duration of Response (DOR)
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Assessment method [9]
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DOR analyses will be conducted for those patients in the Efficacy Analysis Set who achieve an objective response and is defined as the time from first objective status assessment of CR or PR until documentation of objective disease progression or death from any cause. Patients who do not progress and do not die will be censored on the date of last adequate tumor assessment. If no further adequate post-treatment tumor assessments were obtained for a patient, DOR will be censored at the date of the objective response (i.e., zero duration). DOR will be assessed based on RECIST v1.1.
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Timepoint [9]
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Up to approximately 24 months
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Secondary outcome [10]
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Expansion Phase Only: Progression-Free Survival (PFS)
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Assessment method [10]
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PFS is defined as the time from administration of the first dose of ONM-501 until documentation of objective disease progression or death from any cause. Patients who do not progress and do not die will be censored on the date of last adequate tumor assessment. If no adequate post treatment tumor assessments were obtained for a patient, PFS will be censored at Day 1 (i.e., zero duration). The PFS analysis will be conducted using the Safety Analysis Set. Assess the biological effects of IT ONM-501 demonstrated by changes in immune cells, immune cell markers, serum cytokines (such as TNF-?, IFN-?, IFN-ß, and others consistent with activation of the cGAS-STING pathway) and gene expression patterns
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Timepoint [10]
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Up to approximately 24 months
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Secondary outcome [11]
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Expansion Phase Only: Overall Survival (OS)
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Assessment method [11]
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OS is defined as the time from the date of first dose administration to the date of death.
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Timepoint [11]
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Up to approximately 24 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/10/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/08/2026
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Actual
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Sample size
Target
168
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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St Vincent's Hospital - Darlinghurst
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Recruitment hospital [2]
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Cancer Care Wollongong - Wollongong
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Recruitment hospital [3]
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University of the Sunshine Coast Clinical Trials - Buderim
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Recruitment hospital [4]
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Tasman Oncology Research - Southport
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Recruitment hospital [5]
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Southern Oncology Clinical Research Unit - Bedford Park
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Recruitment hospital [6]
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St John of God Subiaco Hospital - Subiaco
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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4556 - Buderim
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Recruitment postcode(s) [4]
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4215 - Southport
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Recruitment postcode(s) [5]
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- Bedford Park
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Recruitment postcode(s) [6]
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6008 - Subiaco
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Ohio
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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United States of America
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State/province [5]
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Texas
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Country [6]
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United States of America
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State/province [6]
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Virginia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
OncoNano Medicine, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06022029
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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[email protected]
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Address
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Country
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Phone
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(682) 285-1411
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06022029
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