RECRUITING

Intratumoral PH-762 for Cutaneous Carcinoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Dose Escalation Study of Neoadjuvant Intratumoral PH-762 for Cutaneous Squamous Cell Carcinoma, Melanoma, or Merkel Cell Carcinoma

Quick Facts

Study Start:2023-11-07
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06014086

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed cutaneous squamous cell carcinoma (cSCC), melanoma, or Merkel cell carcinoma, meeting one of the following criteria:
  2. * cSCC, resectable local tumors: must be Stage II or lower, amenable to curative resection and in a location where acceptable surgical margins are anticipated
  3. * 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
  4. * cSCC, metastatic disease: disease has progressed during or following prior checkpoint inhibitor therapy (anti-PD-1 or anti-PD-L1 antibody)
  5. * 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
  6. * 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)
  7. * 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.
  1. * Other malignancy within prior 3 years, with certain exceptions.
  2. * Current cancer chemotherapy, radiation therapy, immunotherapy, or biologic therapy.
  3. * 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.
  4. * Females who are pregnant or are breastfeeding.

Contacts and Locations

Study Contact

Linda Mahoney
CONTACT
508-929-3601
lmahoney@phiopharma.com
Mary C Spellman, MD
CONTACT
mspellman@panclarity.com

Principal Investigator

Linda Mahoney
STUDY_DIRECTOR
Phio Pharmaceuticals Inc.

Study Locations (Sites)

Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
George Washington University
Washington, District of Columbia, 20037
United States
Integrity Research
Delray Beach, Florida, 33445
United States
Centricity Research
Columbus, Ohio, 43213
United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Phio Pharmaceuticals Inc.

  • Linda Mahoney, STUDY_DIRECTOR, Phio Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-07
Study Completion Date2025-09

Study Record Updates

Study Start Date2023-11-07
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

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