Intratumoral PH-762 for Cutaneous Carcinoma

Launched by PHIO PHARMACEUTICALS INC. · Aug 25, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called PH-762 for patients with certain skin cancers, including squamous cell carcinoma, melanoma, and Merkel cell carcinoma. The main goal is to see how safe this treatment is, how well the body handles it, and how the tumors respond after receiving the drug. Participants in the trial will receive four injections of PH-762 directly into their tumor over four weeks. After the treatment, the tumor will be surgically removed about two weeks later.

To be eligible for the trial, participants need to have a confirmed diagnosis of one of the targeted skin cancers that meet specific criteria, such as having tumors that are at a certain stage and can be surgically removed. The study is open to adults aged 65 and older, and both men and women can participate. However, people with certain medical conditions or who are currently receiving other cancer treatments may not be able to join. If you take part in this trial, you will be closely monitored for safety and how well the treatment works for your cancer.

Gender

ALL

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.