← Back to Search

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

Must not have

Females who are breastfeeding or pregnant at screening or baseline

Has uncontrolled or poorly controlled hypertension as defined by a sustained BP > 9

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

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

Select...

My bone marrow is working well.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently pregnant or breastfeeding.

Select...

My blood pressure is consistently high.

Select...

I have an autoimmune disease or needed high-dose steroids recently.

Select...

I need to take corticosteroids for my condition.

Select...

I am not willing to use effective birth control.

Select...

I am currently being treated for an infection.

Select...

I haven't had a major heart event in the last 6 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Dose Escalation and Expansion Phases: AUCinf

Dose Escalation and Expansion Phases: AUCt

Dose Escalation and Expansion Phases: CL/F

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1470

0 / 11Eligibility criteria met