피부암종에 대한 종양내 PH-762
피부 편평 세포 암종, 흑색종 또는 메르켈 세포 암종에 대한 신보조 종양내 PH-762의 용량 증량 연구
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Arizona
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Gilbert, Arizona, 미국, 85234
- Banner MD Anderson Cancer Center
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California
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San Diego, California, 미국, 92108
- Paradigm Clinical Research
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Florida
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Delray Beach, Florida, 미국, 33445
- Integrity Research
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Nevada
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Reno, Nevada, 미국, 89509
- Skin Cancer and Dermatology Institute
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Ohio
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Columbus, Ohio, 미국, 43213
- Centricity Research
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
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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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Sequential escalating doses of PH-762.
Escalating doses of PH-762 are to be tested, with an observation period between doses. |
PH-762 is a potent RNAi molecule targeting PD-1. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adverse Events
기간: 16 weeks
|
Incidence, severity, seriousness and relatedness of all treatment-emergent adverse events. |
16 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pharmacokinetics: maximum plasma concentration (Cmax)
기간: 3.5 weeks
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Maximum concentration of PH-762 following intratumoral injection. |
3.5 weeks
|
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Pharmacokinetics: time to maximum plasma concentration (Tmax)
기간: 3.5 weeks
|
Time to maximum concentration of PH-762 following intratumoral injection. |
3.5 weeks
|
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Pharmacokinetics: area under the curve to last quantifiable plasma concentration (AUClast)
기간: 3.5 weeks
|
Exposure to PH-762 through last quantifiable concentration following intratumoral injection. |
3.5 weeks
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Pathologic response
기간: 5 weeks
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Pathological response will be assessed by relative amount of viable tumor in resection specimens of the treated lesion. |
5 weeks
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Tumor burden
기간: 5 weeks
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Change in tumor burden will be assessed per RECIST/ iRECIST guidelines for the treated lesion. |
5 weeks
|
공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Linda Mahoney, Phio Pharmaceuticals Inc.
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PHIO-762-2301
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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