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Intratumoral PH-762 for Cutaneous Carcinoma

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PH-762
Sponsored by
Phio Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phio Pharmaceuticals Corp.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sequential escalating doses of PH-762.

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2023
Last Updated
August 25, 2023
Sponsor
Phio Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06014086
Brief Title
Intratumoral PH-762 for Cutaneous Carcinoma
Official Title
Dose Escalation Study of Neoadjuvant Intratumoral PH-762 for Cutaneous Squamous Cell Carcinoma, Melanoma, or Merkel Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phio Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Skin, Malignant Melanoma of Skin, Merkel Cell Carcinoma of Skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequential escalating doses of PH-762.
Arm Type
Experimental
Arm Description
Escalating doses of PH-762 are to be tested, with an observation period between doses.
Intervention Type
Drug
Intervention Name(s)
PH-762
Intervention Description
PH-762 is a potent RNAi molecule targeting PD-1.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence, severity, seriousness and relatedness of all treatment-emergent adverse events.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics: maximum plasma concentration (Cmax)
Description
Maximum concentration of PH-762 following intratumoral injection.
Time Frame
3.5 weeks
Title
Pharmacokinetics: time to maximum plasma concentration (Tmax)
Description
Time to maximum concentration of PH-762 following intratumoral injection.
Time Frame
3.5 weeks
Title
Pharmacokinetics: area under the curve to last quantifiable plasma concentration (AUClast)
Description
Exposure to PH-762 through last quantifiable concentration following intratumoral injection.
Time Frame
3.5 weeks
Title
Pathologic response.
Description
Pathological response will be assessed by relative amount of viable tumor in resection specimens of the treated lesion.
Time Frame
5 weeks
Title
Tumor burden.
Description
Change in tumor burden will be assessed per RECIST/ iRECIST guidelines for the treated lesion.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
L Mahoney
Phone
(508) 929-3601
Email
lmahoney@phiopharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
M Spellman, MD
Phone
(508) 929-3601
Email
mspellman@phiopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L Mahoney
Organizational Affiliation
Phio Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Phio Pharmaceuticals Corp.
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L Mahoney
Email
lmahoney@phiopharma.com
First Name & Middle Initial & Last Name & Degree
M Spellman, MD
Email
mspellman@phiopharma.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intratumoral PH-762 for Cutaneous Carcinoma

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