Intratumoral PH-762 for Cutaneous Carcinoma
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| ClinicalTrials.gov Identifier: NCT06014086 |
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Recruitment Status :
Recruiting
First Posted : August 28, 2023
Last Update Posted : November 9, 2023
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| 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 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sequential escalating doses of PH-762.
Escalating doses of PH-762 are to be tested, with an observation period between doses.
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Drug: PH-762
PH-762 is a potent RNAi molecule targeting PD-1. |
- Adverse Events [ Time Frame: 16 weeks ]Incidence, severity, seriousness and relatedness of all treatment-emergent adverse events.
- Pharmacokinetics: maximum plasma concentration (Cmax) [ Time Frame: 3.5 weeks ]Maximum concentration of PH-762 following intratumoral injection.
- Pharmacokinetics: time to maximum plasma concentration (Tmax) [ Time Frame: 3.5 weeks ]Time to maximum concentration of PH-762 following intratumoral injection.
- 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.
- Pathologic response [ Time Frame: 5 weeks ]Pathological response will be assessed by relative amount of viable tumor in resection specimens of the treated lesion.
- Tumor burden [ Time Frame: 5 weeks ]Change in tumor burden will be assessed per RECIST/ iRECIST guidelines for the treated lesion.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
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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.
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
| Contact: L Mahoney | (508) 929-3601 | lmahoney@phiopharma.com | |
| Contact: M Spellman, MD | (508) 929-3601 | mspellman@phiopharma.com |
| United States, Massachusetts | |
| Phio Pharmaceuticals Corp. | Not yet recruiting |
| Marlborough, Massachusetts, United States, 01752 | |
| Contact: L Mahoney lmahoney@phiopharma.com | |
| Contact: M Spellman, MD mspellman@phiopharma.com | |
| United States, Ohio | |
| Centricity Research | Recruiting |
| Columbus, Ohio, United States, 43213 | |
| Contact: Valerie, Research Coordinator 614-336-7880 | |
| Study Director: | L Mahoney | Phio Pharmaceuticals Inc. |
| 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: | November 9, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Carcinoma, Merkel Cell Carcinoma Melanoma Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neoplasms, Squamous Cell Polyomavirus Infections DNA Virus Infections Virus Diseases Infections Tumor Virus Infections Carcinoma, Neuroendocrine Adenocarcinoma |