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Monoclonal Antibodies

ONM-501 + Cemiplimab for Cancer (ON-5001 Trial)

Phase 1

Recruiting

Research Sponsored by OncoNano Medicine, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Participants must have a minimum of one injectable and measurable lesion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 24 months

Awards & highlights

ON-5001 Trial Summary

This trial tests a new drug for cancer treatment with the goal of finding the best dose to use.

Who is the study for?

Adults with advanced, nonresectable or recurrent solid tumors or lymphomas without standard treatment options can join. They must have at least one injectable tumor and meet specific health criteria including HIV management if applicable, adequate organ function, and not be pregnant. Those with recent major heart events, certain other cancers within 2 years, untreated brain metastases, uncontrolled hypertension or infections are excluded.Check my eligibility

What is being tested?

The study is testing ONM-501 alone and combined with Cemiplimab in patients to find the safest and most effective doses. It's an early-phase trial (phase 1) focusing on how much of these drugs can be given safely to people with certain types of cancer.See study design

What are the potential side effects?

Potential side effects may include typical reactions related to immune therapies such as inflammation in different body parts, infusion-related reactions like fever or chills, fatigue, liver issues due to hepatitis history compatibility requirements for participation.

ON-5001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have at least one tumor that can be measured and is suitable for injection.

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My bone marrow is working well.

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I have HIV, am on HAART, my viral load is under 400, and my CD4+ count is over 350.

ON-5001 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

Secondary outcome measures

Dose Escalation and Expansion Phases: AUCinf

Dose Escalation and Expansion Phases: AUCt

Dose Escalation and Expansion Phases: CL/F

+8 more

ON-5001 Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohortsExperimental Treatment2 Interventions

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.

Group II: Part 1b: ONM-501 in Combination with cemiplimabExperimental Treatment2 Interventions

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.

Group III: Part 1a: Monotherapy Dose EscalationExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

OncoNano Medicine, Inc.Lead Sponsor

3 Previous Clinical Trials

104 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Monotherapy Dose Escalation protocol achieved regulatory approval from the FDA?

"There is inadequate data regarding safety and efficacy, so Part 1a: Monotherapy Dose Escalation received a score of one."

Answered by AI

What is the cap on participants for this experiment?

"Indeed, the evidence on clinicaltrials.gov affirms that this medical trial is actively looking to enrol participants and was last revised on October 13th 2023. This project seeks to enlist 168 patients at a single facility."

Answered by AI

Are new participants being admitted to this clinical trial at present?

"Affirmative. The clinical trial is still recruiting according to the information hosted on clinicaltrials.gov, which was first published on October 13th 2023 and last updated that same day. This study requires 168 participants from a single site."

Answered by AI

What key insights are investigators hoping to glean from this research?

"The primary outcome, which will be monitored across a 24 month window, is reported by OncoNano Medicine Inc. to be the Number of Participants with Dose-Limiting Toxicities (DLTs). Additionally, secondary outcomes such as Tmax (Time to Reach Maximum Plasma Concentration), AUCt (Area Under the Concentration-time Curve from Time 0 to Time t) and CL/F (the apparent clearance of ONM-501 where F is the fraction absorbed) are also being gauged during this medical trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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.

2023. "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.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06022029.

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