進行性固形がんに対するRPTR-1-201の早期段階臨床試験 (RaPTR-101)
進行性固形腫瘍におけるT細胞受容体二重特異性療法RPTR-1-201の第1/2相試験
This is an early phase trial designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose escalation and dose expansion parts and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.
調査の概要
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
研究場所
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Dublin、アイルランド
- 募集
- START Dublin
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コンタクト：
- Amy Slater
- 電話番号：+353 1 854 5946
- メール：amy.slater@startdublin.com
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Michigan
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Grand Rapids、Michigan、アメリカ、49546
- 募集
- START Midwest
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コンタクト：
- Jacob Goldberg
- 電話番号：616-954-5561
- メール：jacob.goldberg@startresearch.com
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New York
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Lake Success、New York、アメリカ、11042
- 募集
- START New York-Long Island
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コンタクト：
- Sadia Morium
- 電話番号：363-207-5160
- メール：sadia.morium@startresearch.com
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Texas
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San Antonio、Texas、アメリカ、78229
- 募集
- START San Antonio
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コンタクト：
- Danielle Gillen
- 電話番号：726.215.6915
- メール：danielle.gillen@startresearch.com
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Barcelona、スペイン
- 募集
- START Barcelona
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コンタクト：
- Monica Alemany
- 電話番号：7988 34 932 54 50 30
- メール：monica.alemany@start-barcelona.com
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Logroño、スペイン
- 募集
- START Rioja
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コンタクト：
- Manuel Vaz Herencia
- 電話番号：+34941056827
- メール：Manuel.Vaz@startrioja.com
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Madrid、スペイン
- 募集
- Clinica Universidad de Navarra - Madrid
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コンタクト：
- Pilar Nuñez
- 電話番号：+34 91 353 19 20
- メール：eecc@unav.es
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Madrid、スペイン
- 募集
- START Madrid-FJD
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コンタクト：
- Paloma Delgado
- 電話番号：0034 913 96 41 20
- メール：paloma.delgado@startmadrid.com
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Madrid、スペイン
- 募集
- START Madrid-CIOCC
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コンタクト：
- Javier Arnau
- 電話番号：(+34) 913 96 41 30
- メール：Javier.Arnau@startmadrid.com
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コンタクト：
- Dalmazio Danini
- 電話番号：(+34) 917 56 78 25
- メール：dalmazio.danini@startmadrid.com
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Pamplona、スペイン
- 募集
- Clinica Universidad de Navarra - Pamplona
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コンタクト：
- Pilar Nuñez
- 電話番号：+34 948 255 400
- メール：eecc@unav.es
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Valencia、スペイン
- 募集
- INCLIVA Instituto de Investigación Sanitaria VLC
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コンタクト：
- María Burgos Guerra
- 電話番号：+34 961 973 500
- メール：mburgos@incliva.es
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Lisbon、ポルトガル
- 募集
- START Lisbon
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コンタクト：
- Patrícia Alves
- 電話番号：+351 926 336 629
- メール：startupeu@startresearch.com
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment.
- At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function as defined in the trial protocol.
- Ability to provide written informed consent and comply with trial procedures.
Exclusion Criteria:
- History of another malignancy within 3 years before the first dose of trial intervention, with the exception of malignancies considered cured and not expected to require active therapy (for example, certain skin cancers or in situ malignancies) per protocol.
- Known active leptomeningeal disease or uncontrolled central nervous system metastases.
- Active, clinically significant, autoimmune diseases requiring systemic immunosuppressive therapy.
- Prior allogenic organ transplantation
- Clinically significant uncontrolled medical or psychiatric condition, that in the opinion of the investigator, would increase risk or interfere with trial participation.
- Other protocol-defined inclusion and exclusion criteria apply
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：順次割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Monotherapy
Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol. |
RPTR-1-201 |
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実験的：Combination
Participants receive RPTR-1-201 in combination with an approved or investigational PD-1 monoclonal antibody at doses and schedules defined by the trial protocol. |
RPTR-1-201 PD-1/PD-L1 monoclonal antibody |
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 |
|---|---|---|
|
Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
時間枠：From first dose through 30 days after last dose of trial treatment.
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Number of participants experiencing dose-limiting toxicities and treatment-emergent adverse events, including events considered related to RPTR-1-201, graded according to CTCAE v5.0. |
From first dose through 30 days after last dose of trial treatment.
|
|
Objective Response Rate (ORR) per RECIST v1.1
時間枠：From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).
|
Proportion of participants with a best overall response of complete response or partial response per RECIST v1.1, as assessed by the investigator. |
From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence and severity of adverse events and abnormal safety assessments.
時間枠：From first dose through 30 days after last dose of trial treatment
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Incidence and severity of adverse events, including immune-related adverse events, and abnormal safety assessments (clinical laboratory tests, ECGs, vital signs). |
From first dose through 30 days after last dose of trial treatment
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Pharmacokinetics of RPTR-1-201
時間枠：First dose until end of treatment (assessed up to 24 months).
|
Characterization of the pharmacokinetic maximum observed concentration of RPTR-1-201. |
First dose until end of treatment (assessed up to 24 months).
|
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Progression Free Survival (PFS)
時間枠：From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
|
Time from first dose of RPTR-1-201 to the earliest date of documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first. |
From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
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|
Overall survival (OS)
時間枠：From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).
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Time from first dose of RPTR-1-201 to death from any cause. |
From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).
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Time to Response
時間枠：From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
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Time from first dose of RPTR-1-201 to the first documented complete response or partial response per RECIST v1.1. |
From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
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Pharmacokinetics of RPTR-1-201 (AUC)
時間枠：First dose until end of treatment (assessed up to 24 months)
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Characterization of the pharmacokinetic area under the curve of RPTR-1-201 |
First dose until end of treatment (assessed up to 24 months)
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Immunogenicity of RPTR-1-201
時間枠：First dose until end of treatment (assessed up to 24 months)
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Characterization of the incidence of anti-drug antibodies of RPTR-1-201. |
First dose until end of treatment (assessed up to 24 months)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
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。