ONM-501 + Cemiplimab for Cancer

(ON-5001 Trial)

Recruiting at 10 trial locations

Overseen By [e-mail]

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: OncoNano Medicine, Inc.

Must not be taking: Corticosteroids

Disqualifiers: Active malignancy, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new cancer treatment called ONM-501, both alone and in combination with cemiplimab, an immunotherapy drug. Researchers aim to determine the best and safest dose for patients with advanced solid tumors or lymphomas that cannot be surgically removed or have recurred after treatment. The study is open to individuals with at least one injectable tumor who have not found relief with standard treatments. Participants must have advanced, progressing solid tumors or lymphomas. Those with stable hepatitis B or C or living with HIV may still qualify. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ONM-501 is generally safe when used alone. In a study with 39 patients, early signs indicated potential benefits, and the treatment was found to be safe. Importantly, no severe side effects prevented doctors from increasing the dose.

When combined with another drug, cemiplimab, the treatment remains safe. In the same study, 24 patients received this combination, and again, no severe side effects were reported. Cemiplimab, also known as Libtayo, is already approved for treating other types of cancer and has a good safety record.

Overall, both ONM-501 alone and in combination with cemiplimab appear safe based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard cancer treatments, which often include broad-spectrum chemotherapy or radiation, ONM-501 + Cemiplimab offers a targeted approach. ONM-501 is administered directly into the tumor, aiming to stimulate the immune system right at the cancer site, potentially boosting its effectiveness. Combined with Cemiplimab, an immune checkpoint inhibitor, this treatment could enhance the body's natural defenses to fight cancer cells more efficiently. Researchers are excited about this combination because it may lead to better outcomes with fewer systemic side effects compared to traditional treatments.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that ONM-501, one of the treatments in this trial, has promising effects against tumors when used alone. Early studies found it well tolerated and potentially beneficial. In this trial, some participants will receive ONM-501 as monotherapy, while others will receive it combined with cemiplimab. When combined with cemiplimab, a drug that helps the immune system fight certain cancers, the combination did not cause serious side effects in participants. Cemiplimab has proven effective in treating advanced skin and lung cancers, helping patients live longer. Together, ONM-501 and cemiplimab could offer a powerful treatment option for advanced solid tumors and lymphomas. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

My bone marrow is working well.

My liver 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• ONM-501

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.

How Is the Trial Designed?

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 European Union, United States, Canada, Brazil for the following indications:

Approved in European Union as Libtayo for:

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

Approved in United States as Libtayo for:

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

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)

Who Is Running the Clinical Trial?

OncoNano Medicine, Inc.

Lead Sponsor

Trials

4

Recruited

270+

Published Research Related to This Trial

Cemiplimab-rwlc (Libtayo) is an FDA-approved immunotherapy for advanced cutaneous squamous cell carcinoma (CSCC) that works by blocking the PD-1 receptor, enhancing the immune system's ability to fight tumors.

Clinical trials have shown that cemiplimab is effective in treating CSCC, although common side effects and safety issues were noted, highlighting the need for ongoing research to improve treatment outcomes and reduce toxicity.

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]

Cemiplimab-rwlc is a newly approved PD-1/L1 inhibitor for first-line treatment of metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK mutations, either alone or with chemotherapy.

This review highlights the differences in patient populations studied for cemiplimab compared to other treatments, emphasizing its role in expanding options for NSCLC patients.

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]

At 35 months of follow-up, patients with advanced non-small-cell lung cancer and high PD-L1 expression treated with cemiplimab had a median overall survival of 26.1 months, significantly better than the 13.3 months for those receiving chemotherapy, indicating a strong survival benefit from cemiplimab.

The addition of chemotherapy to cemiplimab after disease progression resulted in a median overall survival of 15.1 months, suggesting that this combination could be an effective second-line treatment option for patients with advanced non-small-cell lung cancer.

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]

In a Phase 1/2 trial involving 106 patients with relapsed and refractory multiple myeloma, the combination of cemiplimab (anti-PD-1) and isatuximab (anti-CD38) showed a marginal increase in response rates, with 25% of patients responding in the cemiplimab combination groups compared to 11.8% in the isatuximab-only group.

Despite the increased response rates, the addition of cemiplimab did not lead to statistically significant improvements in progression-free or overall survival after a median follow-up of nearly 10 months, and there were no major safety concerns associated with the combination therapy.

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]

Cemiplimab is a PD-1 monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, which is crucial for enhancing the immune response against cancer cells.

In September 2018, cemiplimab received FDA approval for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma who cannot undergo curative surgery or radiation, marking a significant advancement in cancer treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Cemiplimab (Libtayo®) is the first approved immunotherapy for patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who cannot undergo surgery or radiotherapy, showing a clinically significant objective response rate in the phase II EMPOWER-CSCC 1 trial.

The treatment has a durable effect, with the median duration of response and overall survival not yet reached, and it has an acceptable safety profile, with manageable immune-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Cemiplimab is the first FDA-approved treatment for patients with advanced cutaneous squamous cell carcinoma (CSCC) who cannot undergo curative surgery or radiation, demonstrating rapid and substantial antitumor efficacy in phase II clinical trials.

The treatment has an acceptable safety profile, with low rates of treatment discontinuation (7%) and death (3%), although current recommendations are based mainly on phase II data due to the lack of an approved comparator agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS2693

A phase 1 dose-escalation and expansion study of an ... The primary endpoint is to evaluate safety of ONM-501 monotherapy as evidenced by the number of dose limiting toxicities and treatment-emergent ...

2. onconano.com onconano.com/press-releases/onconano-medicine-announces-presentation-at-aacr-nic-eortc-international-conference-on-molecular-targets-and-cancer-therapeutics-tt7jl

OncoNano Medicine Presents First-in-Human Data ... In the dose-escalation and dose-finding study, ONM-501 was well tolerated and demonstrated early signs of clinical benefit.

3. jitc.bmj.com jitc.bmj.com/content/10/Suppl_2/A1198

1155 ONM-501, a polyvalent STING agonist, exhibits anti- ... Conclusions ONM-501 demonstrated marked anti-tumor efficacy as a monotherapy and in combination with anti-PD1 in murine syngeneic tumor models.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06022029

Study Details | NCT06022029 | A Dose Escalation and ... 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) ...

5. finance.yahoo.com finance.yahoo.com/news/onconano-medicine-presents-first-human-110000651.html

OncoNano Medicine Presents First-in-Human Data ... Results show durable responses and prolonged stable disease in patients with advanced solid tumors; combination with Libtayo® (cemiplimab) ...