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Intratumoral PH-762 for Cutaneous Carcinoma

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ClinicalTrials.gov Identifier: NCT06014086
Recruitment Status : Recruiting
First Posted : August 28, 2023
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Phio Pharmaceuticals Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Skin Malignant Melanoma of Skin Merkel Cell Carcinoma of Skin Drug: PH-762 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Escalation Study of Neoadjuvant Intratumoral PH-762 for Cutaneous Squamous Cell Carcinoma, Melanoma, or Merkel Cell Carcinoma
Actual Study Start Date : November 7, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 16 weeks ]
    Incidence, severity, seriousness and relatedness of all treatment-emergent adverse events.


Secondary Outcome Measures :
  1. Pharmacokinetics: maximum plasma concentration (Cmax) [ Time Frame: 3.5 weeks ]
    Maximum concentration of PH-762 following intratumoral injection.

  2. Pharmacokinetics: time to maximum plasma concentration (Tmax) [ Time Frame: 3.5 weeks ]
    Time to maximum concentration of PH-762 following intratumoral injection.

  3. 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.

  4. 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. Tumor burden [ Time Frame: 5 weeks ]
    Change in tumor burden will be assessed per RECIST/ iRECIST guidelines for the treated lesion.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06014086


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

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: David, Research Coordinator    480-256-5412      
United States, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact: Kendall, Research Coordinator    202-994-1419      
United States, Florida
Integrity Research Recruiting
Delray Beach, Florida, United States, 33445
Contact: Monica, Research Coordinator    561-935-9865      
United States, Ohio
Centricity Research Recruiting
Columbus, Ohio, United States, 43213
Contact: Valerie, Research Coordinator    614-336-7880      
Sponsors and Collaborators
Phio Pharmaceuticals Inc.
Investigators
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Study Director: Linda Mahoney Phio Pharmaceuticals Inc.
More Information
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Responsible Party: Phio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT06014086    
Other Study ID Numbers: PHIO-762-2301
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Carcinoma
Melanoma
Carcinoma, Squamous Cell
Melanoma, Cutaneous Malignant
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Skin Neoplasms
Neoplasms by Site
Skin Diseases
Neoplasms, Squamous Cell
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Infections
Tumor Virus Infections
Carcinoma, Neuroendocrine
Adenocarcinoma