Intratumoral PH-762 for Cutaneous Carcinoma

NCT06014086 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PHIO-762-2301
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Squamous Cell Carcinoma of the Skin; Malignant Melanoma of Skin; Merkel Cell Carcinoma of Skin

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Incidence, severity, seriousness and relatedness of all treatment-emergent adverse events.

  16 weeks

Secondary Outcomes (5)

• Pharmacokinetics: maximum plasma concentration (Cmax)

  3.5 weeks

• Pharmacokinetics: time to maximum plasma concentration (Tmax)

  3.5 weeks

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

  3.5 weeks

• Pathologic response

  5 weeks

• Tumor burden

  5 weeks

Study Arms (1)

Sequential escalating doses of PH-762.

EXPERIMENTAL

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

Drug: PH-762

Interventions

PH-762 DRUG

PH-762 is a potent RNAi molecule targeting PD-1.

Sequential escalating doses of PH-762.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phio Pharmaceuticals Inc.: lead
• Prosoft Clinical: collaborator

Study Sites (5)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Paradigm Clinical Research

San Diego, California, 92108, United States

Location

Integrity Research

Delray Beach, Florida, 33445, United States

Location

Skin Cancer and Dermatology Institute

Reno, Nevada, 89509, United States

Location

Centricity Research

Columbus, Ohio, 43213, United States

Location

Related Publications (1)

• 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.

  PMID: 39697325 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Linda Mahoney

  Phio Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: November 7, 2023
• Primary Completion: December 29, 2025
• Study Completion: March 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)