A Phase 3 Trial in Advanced Epithelioid Mesothelioma (sTEADfast)
2026年9月11日 更新者：Vivace Therapeutics, Inc
A Phase 3, Randomized, Open-label Trial Comparing VT3989 Versus Gemcitabine or Vinorelbine in Participants With Advanced Epithelioid Mesothelioma, Who Previously Received Platinum-Based Systemic Chemotherapy and Immunotherapy
This randomized, open-label, multicenter Phase 3 trial will compare VT3989 with Investigator's choice of gemcitabine or vinorelbine in adults with advanced epithelioid pleural mesothelioma whose disease progressed after prior platinum-based systemic chemotherapy and immunotherapy.
調査の概要
詳細な説明
Approximately 350 participants will be randomized 1:1 to VT3989 (Arm A) or Investigator's choice chemotherapy with gemcitabine or vinorelbine (Arm B).
VT3989 will be administered orally at 100 mg once daily for 2 weeks on treatment followed by 2 weeks off treatment in each 4-week cycle. Comparator treatment will be gemcitabine or vinorelbine using the protocol-specified regimen or local prescribing/institutional practice.
The trial includes screening, treatment, safety follow-up, and survival follow-up periods. A QTc Sub-Study will evaluate cardiac repolarization using time-matched pharmacokinetic samples and ECGs in approximately 25 Arm A participants. Overall survival is the primary endpoint; BICR-assessed progression-free survival is the key secondary endpoint.
研究の種類
介入
入学 (推定)
350
段階
- フェーズ 3
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：Arick Wong
- 電話番号：650-666-2753
- メール：vt3989-003@vivacetherapeutics.com
研究連絡先のバックアップ
- 名前：Dereck Amakye
- 電話番号：650-666-2753
- メール：info@vivacetherapeutics.com
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, age 18 years or older at informed consent.
- Pathologically confirmed advanced epithelioid pleural mesothelioma previously treated with platinum-based systemic chemotherapy and immunotherapy, given sequentially or concurrently.
- Radiologically measurable disease by modified RECIST v1.1 or RECIST v1.1.
- ECOG: 0-1.
- Adequate organ functions, including the liver, kidneys, and hematopoietic system.
Exclusion Criteria:
- Active brain metastases or primary CNS (central nervous system) tumors.
- History of leptomeningeal metastases
- Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Known HIV positive or active Hepatitis B or Hepatitis C
- Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents
- Corrected QT (QTcF) interval > 470 msec (using Fridericia's correction formula).
- Women who are pregnant or breastfeeding
- Non-pleural mesothelioma at initial diagnosis or an aggressive histologic type such as sarcomatoid or biphasic mesothelioma.
- Prior treatment with a TEAD inhibitor, including VT3989 or another agent targeting the same molecular pathway.
- Prior receipt of both comparator treatments, gemcitabine and vinorelbine, alone or in combination, or known hypersensitivity to both. A participant who received only one comparator may enroll but must not be assigned to that same comparator.
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：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 |
|---|---|
|
実験的：Arm A - VT3989
VT3989 monotherapy in 28-day cycles until BICR-verified progression, unacceptable toxicity, withdrawal, or another protocol-specified reason.
|
• 100 mg orally once daily for 2 weeks on treatment followed by 2 weeks off treatment (2W/2W) in each 4-week cycle
|
|
アクティブコンパレータ：Arm B - Investigator's Choice Chemotherapy
The Investigator selects 21-day cycle of gemcitabine or vinorelbine.
Administration and dose modification may follow the protocol, local prescribing information, or institutional practice.
|
• 1,000 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice
• 25-30 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice
|
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 |
|---|---|---|
|
Overall Survival (OS)
時間枠：Approximately 32-35 months after first randomization
|
Time from randomization to death from any cause.
Participants without an observed death will be censored at the last date known alive or the analysis cut-off date, whichever is earlier.
|
Approximately 32-35 months after first randomization
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-Free Survival by BICR
時間枠：From randomization through radiologic progression, death, up to approximately 3 years or more
|
Time from randomization to the first BICR-assessed radiologic progressive disease or death, using protocol-defined censoring rules.
|
From randomization through radiologic progression, death, up to approximately 3 years or more
|
|
Treatment-Emergent Adverse Events and Serious Adverse Events
時間枠：From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.
|
Incidence and severity of Treatment-Emergent Adverse Events and Serious Adverse Events
|
From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.
|
|
Disease-related symptoms and health-related quality of life outcomes
時間枠：Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
|
Disease-related symptoms, treatment side effects, functioning, and health-related quality of life outcomes and time to deterioration.
|
Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
|
|
Overall Response Rate by BICR
時間枠：Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
|
Overall Response Rate by BICR Proportion with best overall response of complete response or partial response by RECIST v1.1 and/or modified RECIST v1.1, assessed by BICR.
|
Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
|
|
Duration of Response
時間枠：From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more
|
Among participants with a complete or partial response, time from first documented response to progressive disease or death, with protocol-defined censoring.
|
From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more
|
|
Disease Control Rate by BICR
時間枠：Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
|
Proportion with best overall response of complete response, partial response, or stable disease by RECIST v1.1 and/or modified RECIST v1.1, assessed by BICR.
|
Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
|
|
Time to Response
時間枠：From randomization to first documented response; up to approximately 3 years or more
|
Time from randomization to the first documented complete or partial response by RECIST v1.1 and/or modified RECIST v1.1.
|
From randomization to first documented response; up to approximately 3 years or more
|
|
EORTC QLQ-LC13
時間枠：Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
|
Lung cancer- and treatment-related symptoms using the EORTC Quality of Life Questionnaire Lung Cancer Module 13.
|
Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
|
|
EQ-5D-5L
時間枠：Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
|
Health status and health-related quality of life using the EuroQol 5 Dimension-5 Levels instrument.
|
Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
|
|
Time to Deterioration
時間枠：From baseline/randomization through protocol-defined deterioration; up to approximately 3 years or more
|
Time to protocol-defined deterioration in disease-related symptoms and health-related quality of life; detailed definition will be specified in the Statistical Analysis Plan.
|
From baseline/randomization through protocol-defined deterioration; up to approximately 3 years or more
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pharmacokinetic Evaluation - Cmax
時間枠：Up to Cycle 9 (each cycle is 28 days)
|
Peak plasma concentration of VT3989
|
Up to Cycle 9 (each cycle is 28 days)
|
|
Pharmacokinetic Evaluation - AUC
時間枠：Up to Cycle 9 (each cycle is 28 days)
|
Area under the plasma concentration versus time curve (AUC)
|
Up to Cycle 9 (each cycle is 28 days)
|
|
Correlation between VT3989 exposure
時間枠：Up to Cycle 9 (each cycle is 28 days)
|
Correlation between VT3989 exposure
|
Up to Cycle 9 (each cycle is 28 days)
|
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12月1日
一次修了 (推定)
2028年5月1日
研究の完了 (推定)
2031年1月1日
試験登録日
最初に提出
2026年9月1日
QC基準を満たした最初の提出物
2026年9月11日
最初の投稿 (実際)
2026年9月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月17日
QC基準を満たした最後の更新が送信されました
2026年9月11日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- VT3989-003
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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
はい
米国FDA規制機器製品の研究
いいえ
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