ONM-501 + Cemiplimab for Cancer

(ON-5001 Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: OncoNano Medicine, Inc.

Must not be taking: Corticosteroids

Disqualifiers: Active malignancy, Brain metastases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or have recently participated in another clinical trial, you may need to stop those before joining this study.

What data supports the effectiveness of the drug cemiplimab in cancer treatment?

Cemiplimab has been shown to be effective in treating advanced cutaneous squamous cell carcinoma and non-small cell lung cancer, providing significant survival benefits in patients with certain tumor characteristics. It works by enhancing the immune system's ability to fight cancer cells. ^{1 2 3 4 5}

Is the combination of ONM-501 and Cemiplimab safe for humans?

Cemiplimab, also known as Libtayo, has been shown to have an acceptable safety profile in clinical trials for advanced cutaneous squamous cell carcinoma, with most side effects being manageable. However, specific safety data for the combination of ONM-501 and Cemiplimab is not provided in the available research. ^{1 2 3 6 7}

What makes the drug ONM-501 + Cemiplimab unique for cancer treatment?

Cemiplimab is a unique drug because it is a monoclonal antibody that blocks the PD-1 receptor, enhancing the immune system's ability to fight cancer. It is the first approved treatment for advanced cutaneous squamous cell carcinoma, offering a new option for patients who cannot undergo surgery or radiation. ^{1 2 3 6 7}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

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

My bone marrow is working well.

Exclusion Criteria

Is participating in another therapeutic clinical trial

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

I am currently pregnant or breastfeeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy Dose Escalation

ONM-501 is administered as intratumoral injections once per week for three weeks, followed by three weeks without ONM-501 administration. Each dosing cycle is 21 days.

6 weeks

3 visits (in-person)

Combination Therapy Dose Finding

ONM-501 is administered in combination with cemiplimab. ONM-501 is given once per week for three weeks, followed by three weeks without administration. Cemiplimab is administered once every three weeks.

6 weeks

3 visits (in-person) for ONM-501, 1 visit (in-person) for cemiplimab

Combination Therapy Dose Expansion

Once recommended doses are determined, the expansion phase enrolls patients in indication-specific cohorts.

Variable, up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

Treatment Details

Interventions

• Cemiplimab (Monoclonal Antibodies)
• ONM-501 (Other)

Trial Overview 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.

Participant Groups

Group I: Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohorts Experimental Treatment 2 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 cemiplimab Experimental Treatment 2 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 Escalation Experimental Treatment 1 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.

Cemiplimab is already approved in Canada, Brazil for the following indications:

Approved in Canada as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in Brazil as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Allegheny Health Network Pittsburg, PA

Gabrail Cancer Center Research Canton, OH

California Research Institute Los Angeles, CA

Virginia Cancer Specialists, PC Fairfax, VA

More Trial Locations

Who Is Running the Clinical Trial?

OncoNano Medicine, Inc.

Lead Sponsor

Trials

4

Patients Recruited

270+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. Ahn, J., Nagasaka, M.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. Ahmed, SR., Petersen, E., Patel, R., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab: First Global Approval. Markham, A., Duggan, S.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isatuximab in combination with cemiplimab in patients with relapsed/refractory multiple myeloma: A phase 1/2 study. Lesokhin, A., LeBlanc, R., Dimopoulos, MA., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial. Özgüroğlu, M., Kilickap, S., Sezer, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab in advanced cutaneous squamous cell carcinoma. Naik, PP.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. Lee, A., Duggan, S., Deeks, ED.[2020]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Cemiplimab: First Global Approval. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Isatuximab in combination with cemiplimab in patients with relapsed/refractory multiple myeloma: A phase 1/2 study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Cemiplimab in advanced cutaneous squamous cell carcinoma. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. [2020]