A Phase 3 Trial in Advanced Epithelioid Mesothelioma (sTEADfast)
2026년 9월 11일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
350
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Arick Wong
- 전화번호: 650-666-2753
- 이메일: vt3989-003@vivacetherapeutics.com
연구 연락처 백업
- 이름: Dereck Amakye
- 전화번호: 650-666-2753
- 이메일: info@vivacetherapeutics.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm A - VT3989
VT3989 monotherapy in 28-day cycles until BICR-verified progression, unacceptable toxicity, withdrawal, or another protocol-specified reason.
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• 100 mg orally once daily for 2 weeks on treatment followed by 2 weeks off treatment (2W/2W) in each 4-week cycle
|
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활성 비교기: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: 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.
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Approximately 32-35 months after first randomization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-Free Survival by BICR
기간: From randomization through radiologic progression, death, up to approximately 3 years or more
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Time from randomization to the first BICR-assessed radiologic progressive disease or death, using protocol-defined censoring rules.
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From randomization through radiologic progression, death, up to approximately 3 years or more
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Treatment-Emergent Adverse Events and Serious Adverse Events
기간: From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.
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Incidence and severity of Treatment-Emergent Adverse Events and Serious Adverse Events
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From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.
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Disease-related symptoms and health-related quality of life outcomes
기간: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
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Disease-related symptoms, treatment side effects, functioning, and health-related quality of life outcomes and time to deterioration.
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Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
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Overall Response Rate by BICR
기간: Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
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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.
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Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
|
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Duration of Response
기간: From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more
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Among participants with a complete or partial response, time from first documented response to progressive disease or death, with protocol-defined censoring.
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From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more
|
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Disease Control Rate by BICR
기간: 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.
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Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
|
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Time to Response
기간: From randomization to first documented response; up to approximately 3 years or more
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Time from randomization to the first documented complete or partial response by RECIST v1.1 and/or modified RECIST v1.1.
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From randomization to first documented response; up to approximately 3 years or more
|
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EORTC QLQ-LC13
기간: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
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Lung cancer- and treatment-related symptoms using the EORTC Quality of Life Questionnaire Lung Cancer Module 13.
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Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
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EQ-5D-5L
기간: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
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Health status and health-related quality of life using the EuroQol 5 Dimension-5 Levels instrument.
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Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
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Time to Deterioration
기간: From baseline/randomization through protocol-defined deterioration; up to approximately 3 years or more
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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.
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From baseline/randomization through protocol-defined deterioration; up to approximately 3 years or more
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pharmacokinetic Evaluation - Cmax
기간: Up to Cycle 9 (each cycle is 28 days)
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Peak plasma concentration of VT3989
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Up to Cycle 9 (each cycle is 28 days)
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Pharmacokinetic Evaluation - AUC
기간: Up to Cycle 9 (each cycle is 28 days)
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Area under the plasma concentration versus time curve (AUC)
|
Up to Cycle 9 (each cycle is 28 days)
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Correlation between VT3989 exposure
기간: Up to Cycle 9 (each cycle is 28 days)
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Correlation between VT3989 exposure
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Up to Cycle 9 (each cycle is 28 days)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 12월 1일
기본 완료 (추정된)
2028년 5월 1일
연구 완료 (추정된)
2031년 1월 1일
연구 등록 날짜
최초 제출
2026년 9월 1일
QC 기준을 충족하는 최초 제출
2026년 9월 11일
처음 게시됨 (실제)
2026년 9월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 11일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- VT3989-003
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
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