CAN1012 in Pre-malignant Oral Dysplasia
A Phase I/Ib Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Oral Dysplasia
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Isa Ngirailemesang, RN
- 電話番号：503-215-1979
- メール：canrsrchstudies@providence.org
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Arm A: Day 2-3
CAN1012の標的病変への注入はDay 0に行われます。標準治療（SOC）切除時に採取された標本は、Day 2-3のベースラインと比較して免疫学的変化について評価されます。
|
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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実験的：Arm B: 5日目～7日目
CAN1012の標的病変への注入はDay 0に行われます。標準治療（SOC）切除時に採取された検体は、Day 5-7のベースラインと比較して免疫学的変化について評価されます。
|
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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実験的：アームC: 9日目～11日目
CAN1012の対象病変への投与はDay 0に行われます。標準治療（SOC）切除中に採取された検体は、Day 9-11におけるベースラインと比較した免疫学的変化について評価されます。
|
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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実験的：Arm D: 13日目～15日目
標的病変へのCAN1012の注入はDay 0に行われます。標準治療（SOC）切除中に採取された検体は、Day 13-15のベースラインと比較して免疫学的変化について評価されます。
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety and Tolerability
時間枠：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.
|
Post-operative follow-up visit (30 days after surgery)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Immunologic Monitoring
時間枠：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
時間枠：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)
時間枠：5 years
|
Assess whether recurrence of OED or invasive disease (relapse free survival, RFS) within the 5 years of the trial.
|
5 years
|
協力者と研究者
捜査官
- 主任研究者：Sasha Stanton, MD, PhD、Providence Health & Services
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026000210
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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CAN1012の臨床試験
-
Providence Health & ServicesCanWell Pharma Inc.まだ募集していません