EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer
BrUOG 438: EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Roxanne Wood, MPH
- 電話番号:401-863-3000
- メール:roxanne_wood@brown.edu
研究連絡先のバックアップ
- 名前:BrUOG
- メール:BrUOG@brown.edu
研究場所
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Rhode Island
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Providence、Rhode Island、アメリカ、02903/02906
- Rhode Island and the Miriam Hospitals (Brown University Health)
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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:
- Pathologically confirmed pancreatic adenocarcinoma.
- Clinically staged locally advanced or borderline resectable pancreatic adenocarcinoma.
- Completed neoadjuvant chemotherapy
- Neoadjuvant radiation is allowed
- Planned surgical exploration
- Treatment with ASP-1929 will be at least 4 - 10 weeks after last chemotherapy and radiation.
- Patients with a history of biliary obstruction must have adequate biliary drainage.
Patients meeting the following laboratory criteria for Adequate Organ and Bone Marrow Function:
Platelet Count ≥ 75,000/mm3. Hemoglobin ≥ 8.0 g/dL [NOTE: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g/dL are not eligible] Absolute neutrophil count ≥ 1,000/mm3. [Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1] Alanine aminotransferase (ALT) ≤ 3×ULN Aspartate aminotransferase (AST) ≤ 3×ULN Total Bilirubin ≤ 1.5×ULN or < 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) Creatinine ≤ 3×ULN
- Age ≥ 18
- ECOG performance status 0-1
- For women of pregnancy potential, a negative pregnancy test within 7 days prior to registration.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients with distant metastases.
- Patients with medical co-morbidities that make them not candidates for surgical exploration
- Planned concomitant, non-protocol directed anti-cancer therapy for at least 8 weeks after ASP-1929
- Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade 2.
- History of significant (Grade ≥ 3) cetuximab infusion reactions
- Photosensitizing medications must be discontinued 4 weeks before ASP-1929 PIT treatment, unless medically required.
- No uncontrolled intercurrent illness including but not limited to symptomatic CHF, unstable angina, clinically significant severe cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with study requirements.
- Any other condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive ASP-1929 and/or be exposed to PIT illumination.
- Women who are pregnant or nursing.
- Patients with concomitant malignancies not expected to cause death within 5 years are eligible.
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:なし
- 介入モデル:単一グループの割り当て
- 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:ASP-1929 PIT
Approximately 24 hours prior to surgery patients will receive ASP-1929, IV over 2 hours, in the outpatient clinic.
ASP-1929 is an EGFR targeting antibody conjugated with a laser-light activable dye IR700.
The following day patients will undergo standard surgical exploration.
Patients found to be inoperable will be treated with the laser device (Alluminox platform) over 5 minutes in the operating room to activate ASP-1929 photoimmunotherapy.
Activation of the IR700 dye with red light (690nm) may result in anticancer activity mediated by immunogenic cell death and necrosis, leading to activation of the immune system.
[Patients who are resectable will undergo resection of their pancreatic cancer and will not receive the laser and their tumor will subsequently be evaluated for EGFR receptor saturation.]
Part 1: There will be a 10-patient safety run-in Part 2: If Part 1 is acceptable, an additional 20 patients will receive PIT to determine preliminary efficacy in a total of 30 patients
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Approximately 24 hours prior to surgery, patients will receive ASP-1929, IV over 2 hours, in the outpatient clinic.
ASP-1929 is an EGFR targeting antibody conjugated with a laser-light activable dye IR700 (IRDye 700DX).
The following day patients will undergo standard surgical exploration.
Those patients found to be inoperable on surgical exploration will be treated with the laser device (Alluminox platform) over 5 minutes in the operating room to activate ASP-1929 photoimmunotherapy.
Activation of the IR700 dye with red light (690nm) may result in anticancer activity mediated by immunogenic cell death and necrosis, leading to activation of the immune system.
他の名前:
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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 |
|---|---|---|
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Incidence of treatment related toxicities grade ≥3
時間枠:From start of treatment to 28 days post surgery
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Part 1 | Safert: The primary endpoint is grade 3 or higher ASP-1929 photoimmunotherapy treatment related toxicity within 28 days of surgery.
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From start of treatment to 28 days post surgery
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Number of Participants Reaching 6 Months Progression Free Survival
時間枠:From start of treatment to 6 months post surgery.
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Part 2 (expansion cohort for efficacy): The primary endpoint of this cohort is 6-month progression free survival.
RECIST version 1.1 will be used to assess for response/progression
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From start of treatment to 6 months post surgery.
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協力者と研究者
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
キーワード
その他の研究ID番号
- BrUOG 438
- 1929-IIR-0016 (その他の識別子:Rakuten)
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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