Intratumoral PH-762 for Cutaneous Carcinoma

May 3, 2024 updated by: Phio Pharmaceuticals Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PH-762 is a potent RNAi molecule targeting PD-1. PH-762 can inhibit the immune checkpoint PD-1 in the tumor and thereby impede tumor growth. As a preoperative therapy, it may decrease the lesion size and has the potential to improve surgical morbidity. Intratumoral immunotherapy aims to use the tumor as a 'self-vaccine'. The local immune stimulation can induce robust priming of an anti-tumor immune response while generating systemic (abscopal) tumor responses, mediated by properly activated anti-tumor immune cells in the circulation. Local delivery of immunotherapy is expected to minimize systemic exposure and off-target toxicities.

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
        • Contact:
          • David, Research Coordinator
          • Phone Number: 480-256-5412
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Recruiting
        • George Washington University
        • Contact:
          • Kendall, Research Coordinator
          • Phone Number: 202-994-1419
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Recruiting
        • Integrity Research
        • Contact:
          • Monica, Research Coordinator
          • Phone Number: 561-935-9865
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Centricity Research
        • Contact:
          • Valerie, Research Coordinator
          • Phone Number: 614-336-7880

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequential escalating doses of PH-762.
Escalating doses of PH-762 are to be tested, with an observation period between doses.
Drug: PH-762
PH-762 is a potent RNAi molecule targeting PD-1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 16 weeks
Incidence, severity, seriousness and relatedness of all treatment-emergent adverse events.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics: maximum plasma concentration (Cmax)
Time Frame: 3.5 weeks
Maximum concentration of PH-762 following intratumoral injection.
3.5 weeks
Pharmacokinetics: time to maximum plasma concentration (Tmax)
Time Frame: 3.5 weeks
Time to maximum concentration of PH-762 following intratumoral injection.
3.5 weeks
Pharmacokinetics: area under the curve to last quantifiable plasma concentration (AUClast)
Time Frame: 3.5 weeks
Exposure to PH-762 through last quantifiable concentration following intratumoral injection.
3.5 weeks
Pathologic response
Time Frame: 5 weeks
Pathological response will be assessed by relative amount of viable tumor in resection specimens of the treated lesion.
5 weeks
Tumor burden
Time Frame: 5 weeks
Change in tumor burden will be assessed per RECIST/ iRECIST guidelines for the treated lesion.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phio Pharmaceuticals Inc.

Collaborators

Prosoft Clinical

Investigators

  • Study Director: Linda Mahoney, 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 Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHIO-762-2301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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