What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SCC) include surgical excision, radiation therapy, and topical or systemic chemotherapies. Intratumoral injections, like the PH-762 trial, aim to modulate the tumor response directly within the tumor site. Known side effects of intratumoral injections can include localized pain, swelling, redness, and potential infection at the injection site. Broader treatments like radiation therapy may cause skin irritation, fatigue, and changes in skin color, while systemic chemotherapies can lead to nausea, vomiting, hair loss, and increased risk of infections due to lowered blood cell counts.

What prior FDA approvals exist?

The FDA has approved several treatments for Squamous Cell Carcinoma, including systemic therapies and targeted treatments. Notably, immune checkpoint inhibitors such as pembrolizumab (Keytruda) and nivolumab (Opdivo) have been approved for advanced cases. These drugs work by modulating the immune response to target cancer cells. While intratumoral injections like PH-762 are still under investigation, they represent a novel approach aimed at directly modulating the tumor microenvironment to enhance the body's immune response against the cancer.

What other types of research exist?

<ol> <li>Indium-111-bleomycin complex (111In-BLMC): This treatment has shown increased cytotoxicity and effectiveness in SCC xenograft models, making it a promising alternative. 2.</li> </ol> Intratumoral injection of lipopolysaccharide (LPS): This method has demonstrated complete or nearly total tumor regression in mouse models of glioblastoma, suggesting potential applicability to SCC. 3. Enfortumab Vedotin: This antibody-drug conjugate has shown efficacy in advanced urothelial carcinoma and may be considered for SCC due to its mechanism of targeting cancer cells.

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Virus Therapy

Intratumoral PH-762 for Skin Cancer

Phase 1

Recruiting

Research Sponsored by Phio Pharmaceuticals Inc.

Eligibility Criteria Checklist

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

Must have

Histologically confirmed cutaneous squamous cell carcinoma (cSCC), melanoma, or Merkel cell carcinoma meeting specific criteria

Presence of a minimum of one accessible tumor of ≥ 1.0 cm and < 3.0 cm in longest dimension for intratumoral injection, biopsy, and surgical excision

Must not have

Females who are pregnant or breastfeeding

Current cancer chemotherapy, radiation therapy, immunotherapy, or biologic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests PH-762 injections in adults with certain skin cancers. The treatment helps the immune system recognize and fight the cancer by stopping it from hiding. Patients will receive injections over a period of weeks.

Who is the study for?

This trial is for adults with certain skin cancers: squamous cell carcinoma, melanoma, or Merkel cell carcinoma. They must have at least one tumor between 1 and 3 cm that can be injected and removed surgically. People with other recent cancers, current cancer treatments, serious medical conditions like auto-immune diseases, or who are pregnant/breastfeeding cannot join.

What is being tested?

The trial tests PH-762's safety by giving participants four weekly injections directly into a single tumor on the skin. After these injections, the treated tumor will be surgically removed to study how it responded to PH-762 and what happens to the drug in the body.

What are the potential side effects?

Potential side effects of PH-762 may include reactions at the injection site such as pain or swelling, general discomfort or flu-like symptoms due to immune response activation. The full range of side effects will be studied during this trial.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a specific type of skin cancer.

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I have a tumor between 1.0 cm and 3.0 cm that can be reached for treatment.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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I am currently undergoing treatment for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Events

Secondary study objectives

Pathologic response

Pharmacokinetics: area under the curve to last quantifiable plasma concentration (AUClast)

Pharmacokinetics: maximum plasma concentration (Cmax)

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sequential escalating doses of PH-762.Experimental Treatment1 Intervention

Escalating doses of PH-762 are to be tested, with an observation period between doses.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Squamous Cell Carcinoma (SCC) include surgical excision, radiation therapy, and systemic therapies such as chemotherapy and immunotherapy. Surgical excision physically removes the tumor, while radiation therapy uses high-energy rays to destroy cancer cells. Chemotherapy targets rapidly dividing cells, including cancer cells, to inhibit their growth. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells. Intratumoral injections like PH-762 aim to modulate the tumor microenvironment directly, potentially enhancing the immune system's ability to target and destroy cancer cells locally. Understanding these mechanisms is crucial for SCC patients as it helps tailor treatments to individual needs, potentially improving outcomes and reducing side effects.

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