Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2023-11-07
2026-04-30
Brief Summary
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Detailed Description
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This is a non-comparative study of neoadjuvant monotherapy using PD-1 targeting self-delivering RNAi (PH-762) in adult subjects with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. The study treatment consists of four intratumoral injections of PH-762 at weekly intervals, into a single tumor lesion. Excision of the tumor will occur approximately two weeks following the fourth dose of IT PH-762, and the subjects will be followed for an additional 11 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sequential escalating doses of PH-762.
Escalating doses of PH-762 are to be tested, with an observation period between doses.
PH-762
PH-762 is a potent RNAi molecule targeting PD-1.
Interventions
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PH-762
PH-762 is a potent RNAi molecule targeting PD-1.
Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Prosoft Clinical
OTHER
Phio Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Linda Mahoney
Role: STUDY_DIRECTOR
Phio Pharmaceuticals Inc.
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Paradigm Clinical Research
San Diego, California, United States
Integrity Research
Delray Beach, Florida, United States
Skin Cancer and Dermatology Institute
Reno, Nevada, United States
Centricity Research
Columbus, Ohio, United States
Countries
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References
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Cuiffo B, Maxwell M, Yan D, Guemiri R, Boone A, Bellet D, Rivest B, Cardia J, Robert C, Fricker SP. Self-delivering RNAi immunotherapeutic PH-762 silences PD-1 to generate local and abscopal antitumor efficacy. Front Immunol. 2024 Dec 4;15:1501679. doi: 10.3389/fimmu.2024.1501679. eCollection 2024.
Other Identifiers
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PHIO-762-2301
Identifier Type: -
Identifier Source: org_study_id