Intratumoral PH-762 treatment for skin cancers
Dose Escalation Study of Neoadjuvant Intratumoral PH-762 for Cutaneous Squamous Cell Carcinoma, Melanoma, or Merkel Cell Carcinoma
This study is testing if a new injection called PH-762 can help people with certain skin cancers by making their tumors smaller and improving the results of surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Phio Pharmaceuticals Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 5 sites (Gilbert, Arizona and 4 other locations) |
| Trial ID | NCT06014086 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of intratumoral injections of PH-762, an RNAi molecule targeting PD-1, in patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. Participants will receive four weekly injections into a single tumor, followed by surgical removal of the tumor approximately two weeks later. The study aims to understand the body's response to PH-762 and the tumor's reaction to the treatment, potentially enhancing surgical outcomes and reducing tumor size. This approach utilizes the tumor as a 'self-vaccine' to stimulate an anti-tumor immune response.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma, particularly those with Stage II or lower tumors or metastatic disease that has progressed after prior therapies.
Not a fit: Patients with advanced-stage tumors that are not amenable to surgical resection or those who have not previously undergone checkpoint inhibitor therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and reduce tumor size in patients with specific skin cancers.
How similar studies have performed: Other studies utilizing intratumoral immunotherapy approaches have shown promise, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gilbert, Arizona and 4 other locations
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (Recruiting)
- Paradigm Clinical Research — San Diego, California, United States (Recruiting)
- Integrity Research — Delray Beach, Florida, United States (Recruiting)
- Centricity Research — Columbus, Ohio, United States (Recruiting)
- UPMC Department of Dermatology — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Linda Mahoney
- Email: lmahoney@phiopharma.com
- Phone: 508-929-3601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.