Safety and Tolerability of AI-Designed Pan-Cancer Neoantigen mRNA Vaccine (PAN-NeoVax) in Advanced Solid Tumors
2026年5月5日 更新者：Xingchen Peng、West China Hospital
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of an Artificial Intelligence-Designed Tumor mRNA Vaccine in Patients With Advanced or Metastatic Solid Tumors
This is a phase I, open-label, single-arm, single-center, dose-escalation study to evaluate the safety, tolerability, and preliminary anti-tumor efficacy of PAN-NeoVax, an artificial intelligence (AI)-designed pan-cancer neoantigen mRNA vaccine delivered via lipid nanoparticles (LNP), administered by intratumoral injection in patients with advanced or metastatic solid tumors who have failed second-line therapy.
The study employs a classical "3+3" dose-escalation design with three dose levels (25 μg, 50 μg, and 100 μg mRNA).
Each subject will receive 5 doses of basic immunization (first 4 doses at weekly intervals, fifth dose at 1 month after the fourth dose).
調査の概要
研究の種類
介入
入学 (推定)
9
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Xingchen Peng
- 電話番号：18980606753
- メール：pxx2014@163.com
研究場所
-
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Sichuan
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Chengdu、Sichuan、中国、610000
- まだ募集していません
- West China Hospital
-
コンタクト：
- Xingchen Peng
- 電話番号：18980606753
- メール：pxx2014@163.com
-
Chengdu、Sichuan、中国、646000
- 募集
- The West China Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Male or female patients aged ≥18 and ≤70 years
- Histopathologically confirmed advanced recurrent/metastatic malignant solid tumors that have failed second-line therapy with no standard treatment options available (priority enrollment of advanced head and neck squamous cell carcinoma and malignant melanoma patients)
- ECOG Performance Status score: 0-1
- Estimated life expectancy ≥3 months
- At least 28 days since prior chemotherapy, radiotherapy, or surgery
- At least 6 weeks since prior use of nitrosoureas or mitomycin C
Adequate organ function within 14 days prior to enrollment:
- Hemoglobin ≥90 g/L (no blood transfusion within 14 days)
- Absolute neutrophil count >1.5×10⁹/L
- Platelet count ≥80×10⁹/L
- Total bilirubin ≤1.5×ULN
- ALT or AST ≤2.5×ULN (≤5×ULN if liver metastases present)
- Creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)
- Left ventricular ejection fraction (LVEF) ≥50%
- Signed written informed consent and willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements
Exclusion Criteria:
- Participation in another clinical drug trial within 4 weeks
- Tumor located adjacent to major blood vessels or trachea
- Poorly controlled cardiac conditions: NYHA class >2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention
- Pregnant or breastfeeding women
- Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE v5.0); HIV infection, active HBV or HCV infection
- History of psychotropic substance abuse that cannot be discontinued, or mental disorders
- Active autoimmune disease or history of autoimmune disease (exceptions: vitiligo; childhood asthma in complete remission requiring no adult intervention; asthma requiring bronchodilator intervention is excluded)
- Currently receiving immunosuppressive therapy
- History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism, drug addiction)
- Known allergy, hypersensitivity, or intolerance to PAN-NeoVax or any excipient; history of severe allergic reactions to any drug, food, or vaccine (including anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, Arthus reaction)
- Female subjects with pregnancy plans or male subjects whose partners have pregnancy plans from screening through 12 months after the last dose
- Any serious concomitant disease that, in the investigator's judgment, would jeopardize patient safety or ability to complete the study
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：順次割り当て
- 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 |
|---|---|
|
実験的：PAN-NeoVax Dose Level 1 (25 μg)
|
25 μg PAN-NeoVax administered by intratumoral injection; 5 doses of basic immunization (first 4 doses at weekly intervals, fifth dose at 1 month after the fourth dose).
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実験的：PAN-NeoVax Dose Level 2 (50 μg)
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50 μg PAN-NeoVax administered by intratumoral injection; 5 doses of basic immunization (first 4 doses at weekly intervals, fifth dose at 1 month after the fourth dose).
|
|
実験的：PAN-NeoVax Dose Level 3 (100 μg)
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100 μg PAN-NeoVax administered by intratumoral injection; 5 doses of basic immunization (first 4 doses at weekly intervals, fifth dose at 1 month after the fourth dose).
|
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 |
時間枠 |
|---|---|
|
Number of Participants with DLT
時間枠：From the first dose to 3 weeks post-dose.
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From the first dose to 3 weeks post-dose.
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Objective Response Rate
時間枠：From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
|
From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
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Disease Control Rate
時間枠：From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
|
From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
|
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Time to First Response
時間枠：From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
|
From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
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Duration of Response
時間枠：From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
|
From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.
|
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Progression - Free Survival(PFS)
時間枠：From the time when the patients were enrolled in the study until three months after the last dose was injected. The time window was typically 6 months.
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From the time when the patients were enrolled in the study until three months after the last dose was injected. The time window was typically 6 months.
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Overall Survival(OS)
時間枠：From the time when the patients were enrolled in the study until six months after the last dose was injected. The time window was typically 8 months.
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From the time when the patients were enrolled in the study until six months after the last dose was injected. The time window was typically 8 months.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年4月28日
一次修了 (推定)
2027年4月28日
研究の完了 (推定)
2027年12月28日
試験登録日
最初に提出
2026年4月24日
QC基準を満たした最初の提出物
2026年4月24日
最初の投稿 (実際)
2026年5月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月11日
QC基準を満たした最後の更新が送信されました
2026年5月5日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。