Squamous Cell Carcinoma of the Skin Clinical Trial
Official title:
Dose Escalation Study of Neoadjuvant Intratumoral PH-762 for Cutaneous Squamous Cell Carcinoma, Melanoma, or Merkel Cell Carcinoma
The goal of this clinical trial is to evaluate the safety and tolerability of intratumoral injections of PH-762 in squamous cell carcinoma, melanoma, or Merkel cell carcinomas of the skin, to understand what the body does to the PH-762, and to observe how the tumor responds to the drug. Participants will receive four injections of PH-762 at weekly intervals, into a single tumor, followed by surgical removal of the tumor approximately two weeks later.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Histologically confirmed cutaneous squamous cell carcinoma (cSCC), melanoma, or Merkel cell carcinoma, meeting one of the following criteria: - cSCC, resectable local tumors: must be Stage II or lower, amenable to curative resection and in a location where acceptable surgical margins are anticipated - cSCC, unresectable local tumors: must be Stage II or lower, tumor has been unresponsive to prior radiation therapy or is not a candidate for curative radiation therapy - cSCC, metastatic disease: disease has progressed during or following prior checkpoint inhibitor therapy (anti-PD-1 or anti-PD-L1 antibody) - Melanoma, metastatic disease: Stage IV disease with a cutaneous lesion that has progressed during or following checkpoint inhibitor therapy (anti-PD-1/-PD-L1), and if BRAF-mutation is present, has progressed during or following prior treatment with anti-BRAF + MEK therapy - Merkel cell carcinoma, metastatic disease: Stage IV disease with a cutaneous lesion that has progressed during or following checkpoint inhibitor therapy (anti-PD-1/PD-L1) - A minimum of one tumor of = 1.0 cm and < 3.0 cm in longest dimension that is accessible (with or without imaging guidance) for intratumoral injection and for biopsy and surgical excision must be present. The tumor is not necrotic, hemorrhagic, or friable, and is not within 2 cm of the eye or within 0.5 cm of or on the lip (including the vermilion border) and is not in a mucosal or visceral location. Key Exclusion Criteria: - Other malignancy within prior 3 years, with certain exceptions. - Current cancer chemotherapy, radiation therapy, immunotherapy, or biologic therapy. - Any serious or uncontrolled medical disorder including auto-immune disease that may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results. - Females who are pregnant or are breastfeeding. |
Country | Name | City | State |
---|---|---|---|
United States | Centricity Research | Columbus | Ohio |
United States | Integrity Research | Delray Beach | Florida |
United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
United States | UPMC Department of Dermatology | Pittsburgh | Pennsylvania |
United States | George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Phio Pharmaceuticals Inc. | Prosoft Clinical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events | Incidence, severity, seriousness and relatedness of all treatment-emergent adverse events. | 16 weeks | |
Secondary | Pharmacokinetics: maximum plasma concentration (Cmax) | Maximum concentration of PH-762 following intratumoral injection. | 3.5 weeks | |
Secondary | Pharmacokinetics: time to maximum plasma concentration (Tmax) | Time to maximum concentration of PH-762 following intratumoral injection. | 3.5 weeks | |
Secondary | Pharmacokinetics: area under the curve to last quantifiable plasma concentration (AUClast) | Exposure to PH-762 through last quantifiable concentration following intratumoral injection. | 3.5 weeks | |
Secondary | Pathologic response | Pathological response will be assessed by relative amount of viable tumor in resection specimens of the treated lesion. | 5 weeks | |
Secondary | Tumor burden | Change in tumor burden will be assessed per RECIST/ iRECIST guidelines for the treated lesion. | 5 weeks |
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