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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
27/11/2024

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.
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
Secondary ID [1] 0 0
ON-5001
Universal Trial Number (UTN)
Trial acronym
ON-5001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer 0 0
Diffuse Large B Cell Lymphoma 0 0
Follicular Lymphoma 0 0
Lymphoma, Non-Hodgkin 0 0
Mantle Cell Lymphoma 0 0
Bladder Cancer 0 0
Uveal Melanoma, Recurrent 0 0
Cervix Cancer 0 0
Carcinoma in Situ 0 0
Head and Neck Squamous Cell Carcinoma 0 0
Skin Cancer 0 0
Metastatic Cancer 0 0
Tumor, Solid 0 0
Tumor Recurrence 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Bladder - transitional cell cancer
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Cervical (cervix)
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation and Expansion Phases: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity
Timepoint [1] 0 0
Up to approximately 24 months
Primary outcome [2] 0 0
Dose Escalation and Expansion Phases: Number of Participants with Dose-Limiting Toxicities (DLTs)
Timepoint [2] 0 0
Up to approximately 24 months
Primary outcome [3] 0 0
Dose Escalation and Expansion Phases: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs)
Timepoint [3] 0 0
Up to approximately 24 months
Secondary outcome [1] 0 0
Dose Escalation and Expansion Phases: Cmax
Timepoint [1] 0 0
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).
Secondary outcome [2] 0 0
Dose Escalation and Expansion Phases: t1/2z
Timepoint [2] 0 0
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).
Secondary outcome [3] 0 0
Dose Escalation and Expansion Phases: Tmax
Timepoint [3] 0 0
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).
Secondary outcome [4] 0 0
Dose Escalation and Expansion Phases: AUCt
Timepoint [4] 0 0
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).
Secondary outcome [5] 0 0
Dose Escalation and Expansion Phases: AUCinf
Timepoint [5] 0 0
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).
Secondary outcome [6] 0 0
Dose Escalation and Expansion Phases: CL/F
Timepoint [6] 0 0
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).
Secondary outcome [7] 0 0
Dose Escalation and Expansion Phases: Vz/F
Timepoint [7] 0 0
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).
Secondary outcome [8] 0 0
Expansion Phase Only: Objective Response Rate (ORR)
Timepoint [8] 0 0
Up to approximately 24 months
Secondary outcome [9] 0 0
Expansion Phase Only: Duration of Response (DOR)
Timepoint [9] 0 0
Up to approximately 24 months
Secondary outcome [10] 0 0
Expansion Phase Only: Progression-Free Survival (PFS)
Timepoint [10] 0 0
Up to approximately 24 months
Secondary outcome [11] 0 0
Expansion Phase Only: Overall Survival (OS)
Timepoint [11] 0 0
Up to approximately 24 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/08/2026
Actual
Sample size
Target
168
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Cancer Care Wollongong - Wollongong
Recruitment hospital [2] 0 0
University of the Sunshine Coast Clinical Trials - Buderim
Recruitment hospital [3] 0 0
Tasman Oncology Research - Southport
Recruitment hospital [4] 0 0
Southern Oncology Clinical Research Unit - Bedford Park
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4556 - Buderim
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
- Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
OncoNano Medicine, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trials@OncoNanoMed.com
Address 0 0
Country 0 0
Phone 0 0
(682) 285-1411
Fax 0 0
Email 0 0
trials@onconanomed.com
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