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Disease Attributes

Head and Neck Neoplasms

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Genital Diseases

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All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Immunomodulating Agents

Cemiplimab

Immunoglobulins

Interferons

Antineoplastic Agents, Immunological

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.

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.

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.

ONM-501

Trials@OncoNanoMed.com

Isabela Vazquez

Chintan Gandhi, MD

Allison Reynolds

Joal Beane, MD

Shelly A Evans, MBA, BS, RN

Patrick Wagner, MD

Barb Stadterman

Liza Villaruz, MD

Heather McArthur, MD

Heather McArthur

Hebah Elbahy

Sarina A. Piha-Paul, MD

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.

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.

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.

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 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas

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)

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.

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.

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

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

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

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

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

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

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

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

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.

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

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

OncoNano Medicine, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	Triple Negative... Diffuse Large B... Follicular Lymp... Lymphoma, Non-H... Mantle Cell Lym... Bladder Cancer Uveal Melanoma,... Cervix Cancer Carcinoma in Si... Head and Neck S... Skin Cancer Metastatic Canc... Tumor, Solid Tumor Recurrenc...	ONM-501 Cemiplimab	18 Years -	OncoNano Medicine, Inc.
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	Triple Negative... Diffuse Large B... Follicular Lymp... Lymphoma, Non-H... Mantle Cell Lym... Bladder Cancer Uveal Melanoma,... Cervix Cancer Carcinoma in Si... Head and Neck S... Skin Cancer Metastatic Canc... Tumor, Solid Tumor Recurrenc...	ONM-501 Cemiplimab	18 Years -	OncoNano Medicine, Inc.
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	Triple Negative... Diffuse Large B... Follicular Lymp... Lymphoma, Non-H... Mantle Cell Lym... Bladder Cancer Uveal Melanoma,... Cervix Cancer Carcinoma in Si... Head and Neck S... Skin Cancer Metastatic Canc... Tumor, Solid Tumor Recurrenc...	ONM-501 Cemiplimab	18 Years -	OncoNano Medicine, Inc.

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