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.

NCT06022029 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ON-5001
• Study Type: interventional
• Target: 168
• Locations: 2 countries
• Sites: 16

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.

Conditions

Diffuse Large B Cell Lymphoma; Follicular Lymphoma; Lymphoma, Non-Hodgkin; Mantle Cell Lymphoma; Bladder Cancer; Uveal Melanoma, Recurrent; Cervix Cancer; Carcinoma in Situ; Head and Neck Squamous Cell Carcinoma; Skin Cancer; Metastatic Cancer; Tumor, Solid; Tumor Recurrence; Triple Negative Breast Cancer

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; anti-PD-1 antibody; BRCA1; BRCA2; anti-PD-L1; uveal; NHL; Mantle Zone lymphoma; FL; stimulator of interferon genes

Outcome Measures

Primary Outcomes (3)

• 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)

  Up to approximately 24 months

• 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.

  Up to approximately 24 months

• 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.

  Up to approximately 24 months

Secondary Outcomes (11)

• Dose Escalation and Expansion Phases: Cmax

  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).

• Dose Escalation and Expansion Phases: t1/2z

  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).

• Dose Escalation and Expansion Phases: Tmax

  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).

• Dose Escalation and Expansion Phases: AUCt

  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).

• Dose Escalation and Expansion Phases: AUCinf

  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).

Study Arms (3)

Part 1a: Monotherapy Dose Escalation

EXPERIMENTAL

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.

Drug: ONM-501

Part 1b: ONM-501 in Combination with cemiplimab

EXPERIMENTAL

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.

Drug: ONM-501; Drug: Cemiplimab

Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohorts

EXPERIMENTAL

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.

Drug: ONM-501; Drug: Cemiplimab

Interventions

ONM-501 DRUG

Intratumoral injection

Part 1a: Monotherapy Dose Escalation; Part 1b: ONM-501 in Combination with cemiplimab; Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohorts

Cemiplimab DRUG

Intravenous administration of 350 mg

Also known as: Libtayo

Part 1b: ONM-501 in Combination with cemiplimab; Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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
• Adequate bone marrow function:
• Adequate liver function

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• OncoNano Medicine, Inc.: lead

Study Sites (16)

California Research Institute

Los Angeles, California, 90027, United States

ACTIVE NOT RECRUITING

BRCR Global

Tamarac, Florida, 33321, United States

WITHDRAWN

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

COMPLETED

Ohio State University

Columbus, Ohio, 43210, United States

COMPLETED

Allegheny Health Network

Pittsburgh, Pennsylvania, 15224, United States

COMPLETED

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

COMPLETED

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

COMPLETED

MD Anderson Cancer Center

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

COMPLETED

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Cancer Care Wollongong

Wollongong, New South Wales, 2500, Australia

RECRUITING

University of the Sunshine Coast Clinical Trials

Buderim, Queensland, 4556, Australia

RECRUITING

Tasman Oncology Research

Southport, Queensland, 4215, Australia

RECRUITING

Princess Alexandra Hospital | Metro South Health

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, Australia

COMPLETED

St John of God Subiaco Hospital

Subiaco, Western Australia, 6008, Australia

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Urinary Bladder Neoplasms; Uveal Melanoma; Recurrence; Uterine Cervical Neoplasms; Carcinoma in Situ; Squamous Cell Carcinoma of Head and Neck; Skin Neoplasms; Neoplasm Metastasis; Neoplasms; Lymphoma; Bites and Stings; Breast Neoplasms; Melanoma

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, B-Cell; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Neoplastic Processes; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Central Study Contacts

Trials@OncoNanoMed.com

CONTACT

(682) 285-1411; trials@onconanomed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 1, 2023
• Study Start: October 13, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 29, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

AU (7); US (9)