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Triple Negative Breast CancerPhase 1ON-5001NCT06022029

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 study testing ONM-501 and Cemiplimab in people with Triple Negative Breast Cancer and Diffuse Large B Cell Lymphoma, run by OncoNano Medicine, Inc. at 16 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ONM-501 and Cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
16 sitesin 2 countries
Study dates
13 Oct 2023to 29 Aug 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 alternative standard therapy exists.
  • 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 cells/uL
Show all 23Show fewer
  • Adequate bone marrow function:
  • 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).
  • 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 meninges) may be permitted in a case-by-case basis at the Sponsor's discretion.
  • 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, whichever is shorter.
  • 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

Who cannot join

None listed.

Trial locations and contacts

16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Trials@OncoNanoMed.com contact

(682) 285-1411

trials@onconanomed.com

16 sites in 2 countries

United States9 sites

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

    Completed

  • Ohio State University

    Columbus, Ohio, 43210

    Completed

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Completed

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

    Completed

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Active, not recruiting

  • California Research Institute

    Los Angeles, California, 90027

    Active, not recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224

    Completed

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Completed

  • BRCR Global

    Tamarac, Florida, 33321

    Withdrawn

Other trials in United States

Australia7 sites, 5 recruiting

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia

    Completed

  • University of the Sunshine Coast Clinical Trials

    Buderim, Queensland, 4556

    Hong Shue, MD, +61 421964895, hong.shue@schoc.com.au

    Hong Shue, MD

    Recruiting

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

    Jia (Jenny) Liu, MD, +61293555633, SVHS.CancerResearch@svha.org.au

    Jia (Jenny) Liu, MD

    Recruiting

  • Tasman Oncology Research

    Southport, Queensland, 4215

    Nicole Tasker, PhD, 07 5613 2480 ext. 804, nicole@tasmanhealthcare.com.au

    Andrew Hill, MD

    Recruiting

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

    Active, not recruiting

  • Cancer Care Wollongong

    Wollongong, New South Wales, 2500

    Sue Parker, +61 2 42439708, sparker@cancercarewollongong.com.au

    Daniel Brungs, MD

    Recruiting

  • Princess Alexandra Hospital | Metro South Health

    Woolloongabba, Queensland, 4102

    Rahul Ladwa, MD, 07 31765505, rahul.ladwa@health.qld.gov.au

    Rahul Ladwa, MD

    Recruiting

Other trials in Australia

About this study

Official 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

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.

Read the detailed description

This Phase 1, multi-center trial will consist of three parts: monotherapy dose escalation; combination therapy dose finding; and combination therapy dose expansion exploring two doses in specific tumor indication(s). Each dosing cycle of ONM-501 will be 21 days. ONM 501 will be administered as intratumoral injections once per week for three weeks (on Days 1, 8, and 15), followed by three weeks without ONM-501 administration. The monotherapy dose escalation will utilize an accelerated titration method.

The combination agent will be administered according to standard protocol, once every three weeks. This phase will evaluate ONM-501 in combination with approved immune checkpoint inhibitor (ICI) cemiplimab. Enrollment in this phase will follow a "Rolling 6" or 6+0 methodology - up to 6 patients will be enrolled in a staggered format; dose escalation of ONM-501 will be permitted.

Once the recommended doses for expansion (RDEs) are determined for ONM-501 + ICI combination or ONM-501 monotherapy, the expansion phase of this study will be initiated. The expansion phase will enroll patients in one to three indication-specific expansion cohorts.

Being tested
ONM-501, Cemiplimab
Keywords
Solid tumors, Lymphoma, ONM-501, STING, Intra-tumoral, HNSCC, Breast Cancer, Melanoma, Skin Cancer, cemiplimab, Libtayo, DLBCL, bladder cancer, cervical cancer, metastases, immunotherapy, ICI, TNBC, Triple Negative, mTNBC
Medical subject headings
Triple Negative Breast Neoplasms, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Urinary Bladder Neoplasms, Uveal Melanoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONM-501Drug

    Intratumoral injection

  • CemiplimabDrug

    Also called Libtayo

    Intravenous administration of 350 mg

Study groups in NCT06022029
Study groupRoleWhat they receive
Part 1a: Monotherapy Dose EscalationExperimentalONM-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.
Receives: Drug: ONM-501
Part 1b: ONM-501 in Combination with cemiplimabExperimentalONM-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.
Receives: Drug: ONM-501; Drug: Cemiplimab
Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohortsExperimentalOnce 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.
Receives: Drug: ONM-501; Drug: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation and Expansion Phases: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity

    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)

    Measured: Up to approximately 24 months

  2. Dose Escalation and Expansion Phases: Number of Participants with Dose-Limiting Toxicities (DLTs)

    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.

    Measured: Up to approximately 24 months

  3. Dose Escalation and Expansion Phases: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs)

    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.

    Measured: Up to approximately 24 months

Secondary outcomes (11)

  1. Dose Escalation and Expansion Phases: Cmax

    Cmax is defined as the Maximum Observed Plasma Concentration for ONM-501

    Measured: 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).

  2. Dose Escalation and Expansion Phases: t1/2z

    t1/2z is defined as the Terminal Disposition Phase Half-life for ONM-501

    Measured: 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).

  3. Dose Escalation and Expansion Phases: Tmax

    Tmax is defined as the Time to Reach the Maximum Plasma Concentration (Cmax) for ONM-501

    Measured: 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).

  4. Dose Escalation and Expansion Phases: AUCt

    AUCt is defined as the Area Under the Concentration-time Curve from Time 0 to Time t for ONM-501

    Measured: 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).

  5. Dose Escalation and Expansion Phases: AUCinf

    AUCinf is defined as the Area Under the Concentration-time Curve from Time 0 to Infinity for ONM-501

    Measured: 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).

  6. Dose Escalation and Expansion Phases: CL/F

    CL/F is defined as the apparent clearance of ONM-501 (CL/F), where F is the fraction of the dose absorbed.

    Measured: 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).

  7. Dose Escalation and Expansion Phases: Vz/F

    Vz/F is defined as the apparent volume of distribution of ONM-501 (CL/F), where F is the fraction of the dose absorbed.

    Measured: 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).

  8. Expansion Phase Only: Objective Response Rate (ORR)

    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

    Measured: Up to approximately 24 months

  9. Expansion Phase Only: Duration of Response (DOR)

    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.

    Measured: Up to approximately 24 months

  10. Expansion Phase Only: Progression-Free Survival (PFS)

    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-β, and others consistent with activation of the cGAS-STING pathway) and gene expression patterns

    Measured: Up to approximately 24 months

  11. Expansion Phase Only: Overall Survival (OS)

    OS is defined as the time from the date of first dose administration to the date of death.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2023
  2. Study start13 Oct 2023
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion29 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
In Part 1a patients will receive ONM-501 as a single agent; in Part 1b patients will receive ONM-501 in combination with Cemiplimab; Part 2 will be an expansion of ONM-501 in combination with Cemiplimab.
Masking
None (open label)
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06022029
Sponsor's protocol ID
ON-5001
Acronym
ON-5001
Status last verified
Dec 2025
First submitted
15 Aug 2023
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ONM-501 and Cemiplimab in people with Triple Negative Breast Cancer and Diffuse Large B Cell Lymphoma, run by OncoNano Medicine, Inc. at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trials@OncoNanoMed.com ((682) 285-1411, trials@onconanomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation and Expansion Phases: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity (time frame: Up to approximately 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06022029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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