CAN1012 in Pre-malignant Oral Dysplasia
A Phase I/Ib Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Oral Dysplasia
연구 개요
상세 설명
This is not a dose finding study, and therefore patients may be enrolled to any of the four arms in any order, based on clinical considerations (e.g. OR scheduling). No arm, per specific disease type, may expand beyond the first 3 patients, until 30-day post-op safety evaluation has been completed. Study analysis is planned after a single dose of intralesional CAN1012.
The Safety Analysis Set will consist of all subjects who receive at least one dose of study treatment. The Safety Analysis Set will be used for safety analyses.
The Intent-to-treat (ITT) Analysis Set will consist of all subjects who receive at least one dose of study treatment and have at least one post-Baseline assessment of tumor response.
The disposition of subjects will be summarized by presenting the number of subjects enrolled, the number and percentage of subjects in each analysis population, the number for whom the study drug was discontinued with the reasons for discontinuation, and the number of subjects who discontinued participation in the study with the reason(s) for withdrawal.
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Isa Ngirailemesang, RN
- 전화번호: 503-215-1979
- 이메일: canrsrchstudies@providence.org
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Clinically-identified oral epithelial dysplasia (OED)
- Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.
Laboratory values within 72 hours of Day 0:
- WBC ≥ 2.0 K/µL, ANC ≥ 1.0 K/µL
- Hgb ≥ 10 g/dL
- Platelets ≥ 100,000 K/µL
- Creatinine Clearance (using Cockcroft-Gault)
- AST/ALT ≤ 2.5 x ULN
- Total bilirubin ≤ 3 x ULN, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
- Negative pregnancy test (bHCG urine or serum, people of childbearing potential only)
- Patients and their partners who are capable of conceiving must agree to use effective methods of during the course of treatment and for 165 days after last dose of CAN1012.
Exclusion Criteria:
- Any serious underlying medical or psychiatric condition that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study procedures, completion, or evaluation.
- Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.
- Need for hormonal contraception including oral contraceptives, implant, injectable depots, vaginal rings, skin patches, and the progestin IUD; or any medication that is a sensitive substrate of the major CYPs.
- History of or current active autoimmune diseases which, in the judgment of the investigator, pose an active and significant risk. Vitiligo, lichen planus or lichenoid inflammation, and adequately controlled endocrine deficiencies such as hypothyroidism/ hyperthyroidism are not exclusionary.
- Previous history of bone marrow transplantation or oral Graft Versus Host Disease (GVHD).
- Has an active infection requiring systemic therapy. Investigator may allow if deemed not clinically significant.
- Has active or uncontrolled Hepatitis B, Hepatitis C, or HIV with AIDS (acquired immunodeficiency syndrome)- defined opportunistic infection.
- Has a baseline electrocardiogram (ECG) with a prolonged QTc interval > 480 msec. Medications which have a known and clinically significant risk of QT prolongation may be allowed per investigator discretion.
- Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation, and in the judgment of the investigator still pose an active risk.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Arm A: Day 2-3
CAN1012를 표적 병변에 주입하는 것은 Day 0에 이루어집니다. 표준 치료(SOC) 절제 중에 수집된 샘플은 Day 2-3에 기저선과 비교하여 면역학적 변화를 평가하기 위해 검사됩니다.
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CAN1012 is an IFN-α biased, long-acting, highly selective TLR7 agonist, which acts as an immune modulator capable of priming both innate and adaptive immunity against tumors. It has previously been shown on intralesional injection to turn "cold" tumors "hot" through several mechanisms:
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실험적: B군: 5-7일차
CAN1012의 대상 병변 내 주사는 0일에 시행됩니다. 표준 치료(SOC) 절제 중 수집된 표본은 5-7일에 기준선과 비교하여 면역학적 변화를 평가할 것입니다.
|
CAN1012 is an IFN-α biased, long-acting, highly selective TLR7 agonist, which acts as an immune modulator capable of priming both innate and adaptive immunity against tumors. It has previously been shown on intralesional injection to turn "cold" tumors "hot" through several mechanisms:
|
|
실험적: Arm C: Day 9-11
CAN1012의 표적 병변 주입은 0일에 시행됩니다. 표준 치료(SOC) 절제 과정에서 수집된 검체는 9-11일에 기저치와 비교하여 면역학적 변화를 평가하기 위해 검사됩니다.
|
CAN1012 is an IFN-α biased, long-acting, highly selective TLR7 agonist, which acts as an immune modulator capable of priming both innate and adaptive immunity against tumors. It has previously been shown on intralesional injection to turn "cold" tumors "hot" through several mechanisms:
|
|
실험적: Arm D: 13-15일차
CAN1012를 표적 병변에 주입하는 것은 Day 0에 시행됩니다. 표준 치료(SOC) 절제 중 수집된 표본은 Day 13-15에 기저치와 비교하여 면역학적 변화를 평가합니다.
|
CAN1012 is an IFN-α biased, long-acting, highly selective TLR7 agonist, which acts as an immune modulator capable of priming both innate and adaptive immunity against tumors. It has previously been shown on intralesional injection to turn "cold" tumors "hot" through several mechanisms:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety and Tolerability
기간: Post-operative follow-up visit (30 days after surgery)
|
Assess safety & tolerability of intralesional CAN1012 injection in subjects with OED by monitoring for adverse events and delays in surgery.
Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v6.0 and the Clavien-Dindo grading tool will be used for surgical complications.
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Post-operative follow-up visit (30 days after surgery)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Immunologic Monitoring
기간: 5 years
|
Flow cytometric analysis on pre/post whole blood, and tandem pre/post Multiplex IF for quantitative immunophenotyping, will be performed to ascertain if TLR7 agonists deplete immunosuppressive immune populations within the tumor and if the multiplex immunofluorescence (mIF) changes in the tumor will not be detectable in peripheral blood.
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5 years
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LINE-1 Expression
기간: 5 years
|
LINE-1 (L1) expression at the protein level will be evaluated using multiplex IF.
Paraffin-embedded tissue blocks will be utilized for multiplex IF using the Lunaphore COMET platform.
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5 years
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Relapse Free Survival (RFS)
기간: 5 years
|
Assess whether recurrence of OED or invasive disease (relapse free survival, RFS) within the 5 years of the trial.
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5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sasha Stanton, MD, PhD, Providence Health & Services
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
기타 연구 ID 번호
- 2026000210
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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CAN1012에 대한 임상 시험
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