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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 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.

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.
Antagonism of EG-VEGF Receptors as Targeted Therapy for Choriocarcinoma Progression <i>In Vitro</i> and <i>In Vivo</i>.Emerging drugs for biliary cancer.

Find a Location

Who is running the clinical trial?

Prosoft ClinicalOTHER
6 Previous Clinical Trials
816 Total Patients Enrolled
Phio Pharmaceuticals Inc.Lead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
L MahoneyStudy DirectorPhio Pharmaceuticals Inc.
~12 spots leftby Jun 2025