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De klinische studie NCT06014086 voor Plaveiselcelcarcinoom van de huid, Malignant Melanoma of Skin, Merkelcelcarcinoom van de huid is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Intratumoraal PH-762 voor cutane carcinoom

Recruterend
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De klinische studie NCT06014086 onderzoekt behandeling bij Plaveiselcelcarcinoom van de huid, Malignant Melanoma of Skin, Merkelcelcarcinoom van de huid. Deze Fase 1 interventioneel-studie heeft de status recruterend. Het doel is om 30 deelnemers te includeren vanaf 7 november 2023. De studie wordt geleid door Phio Pharmaceuticals en de voltooiing is gepland op 1 april 2026. Laatste update op ClinicalTrials.gov: 31 juli 2025.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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.

Officiële titel

Dose Escalation Study of Neoadjuvant Intratumoral PH-762 for Cutaneous Squamous Cell Carcinoma, Melanoma, or Merkel Cell Carcinoma

Aandoeningen
Plaveiselcelcarcinoom van de huidMalignant Melanoma of SkinMerkelcelcarcinoom van de huid
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • PHIO-762-2301
NCT-ID
NCT06014086
Startdatum (Werkelijk)
2023-11-07
Laatste update geplaatst
2025-07-31
Verwachte einddatum
2026-04
Inschrijving (Geschat)
30
Studietype
Interventioneel
FASE
Fase 1
Status
Recruterend
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelSequential escalating doses of PH-762.
Escalating doses of PH-762 are to be tested, with an observation period between doses.
PH-762
PH-762 is a potent RNAi molecule targeting PD-1.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Adverse Events
Incidence, severity, seriousness and relatedness of all treatment-emergent adverse events.
16 weeks
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Pharmacokinetics: maximum plasma concentration (Cmax)
Maximum concentration of PH-762 following intratumoral injection.
3.5 weeks
Pharmacokinetics: time to maximum plasma concentration (Tmax)
Time to maximum concentration of PH-762 following intratumoral injection.
3.5 weeks
Pharmacokinetics: area under the curve to last quantifiable plasma concentration (AUClast)
Exposure to PH-762 through last quantifiable concentration following intratumoral injection.
3.5 weeks
Pathologic response
Pathological response will be assessed by relative amount of viable tumor in resection specimens of the treated lesion.
5 weeks
Tumor burden
Change in tumor burden will be assessed per RECIST/ iRECIST guidelines for the treated lesion.
5 weeks
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen

  • 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.

  • 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.
Phio Pharmaceuticals Inc. logoPhio Pharmaceuticals2 actieve klinische studies om te verkennen
Prosoft Clinical logoProsoft Clinical
Centraal Contactpersoon
Contact: Linda Mahoney, 508-929-3601, [email protected]
Contact: Mary C Spellman, MD, [email protected]
5 Studielocaties in 1 landen

Arizona

Banner MD Anderson Cancer Center, Gilbert, Arizona, 85234, United States
Mark I Gimbel, MD, Contact, 480-256-6444
Recruterend

California

Paradigm Clinical Research, San Diego, California, 92108, United States
Jamie, Research Coordinator, Contact, 858-274-4226
Recruterend

Florida

Integrity Research, Delray Beach, Florida, 33445, United States
Research Coordinator, Contact, 561-935-9865
Recruterend

Nevada

Skin Cancer and Dermatology Institute, Reno, Nevada, 89509, United States
Jennifer, Research Coordinator, Contact, 775-336-3665
Recruterend

Ohio

Centricity Research, Columbus, Ohio, 43213, United States
Research Coordinator, Contact, 614-336-7880
Recruterend