Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors (BMD-PLAT)
A Platform Study of In Vivo Inhaled mRNA Technology for Multi-Target Immunotherapy Against Solid Tumors
연구 개요
상세 설명
This is an open-label, single-arm, phase I master platform clinical trial designed to assess the safety, tolerability, pharmacokinetic profiles and preliminary anti-tumor activity of multiple investigational inhaled in-vivo mRNA multi-target immunotherapy candidates in adult subjects diagnosed with unresectable locally advanced or metastatic solid tumors.
The study adopts the standard 3+3 dose-escalation design for each individual mRNA product. Eligible participants will receive study drug via pulmonary inhalation on predefined treatment cycles with gradual dose increment across sequential cohorts to identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). After completion of dose escalation, an optional expansion cohort at RP2D will be enrolled to further characterize safety and preliminary anti-tumor efficacy.
All enrolled patients will undergo regular safety monitoring including adverse event recording, laboratory examinations, pulmonary function test and radiological tumor assessment per protocol schedule. The primary study endpoints focus on treatment-related adverse events and MTD determination; secondary endpoints include objective response rate, disease control rate, duration of response as well as pharmacokinetic parameters of inhaled mRNA agents. Subjects will continue assigned study treatment until confirmed disease progression, unacceptable toxicity, withdrawal of consent or study closure.
연구 유형
등록 (추정된)
단계
- 초기 1단계
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Male or female patients aged ≥ 18 years.
- Confirmed diagnosis of advanced lung cancer (driver gene negative or targeted therapy failed) or pulmonary metastatic solid tumors, with no standard treatment options available or who have failed prior standard therapies.
- Presence of at least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function, including hematologic, hepatic, and renal function.
- Ability to understand and sign the informed consent form.
- Expected survival of at least 12 weeks.
Exclusion Criteria:
- History of severe hypersensitivity to mRNA-based therapies or components of the study drug.
- Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids).
- Prior allogeneic stem cell or solid organ transplantation.
- Current use of other investigational agents within 4 weeks before the first dose of study treatment.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Pregnant or breastfeeding women.
- Any condition that, in the investigator's opinion, would interfere with study compliance or safety.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Inhaled mRNA Immunotherapy
All enrolled subjects will receive inhaled mRNA immunotherapy via Breezhaler dry powder inhaler.
Dose escalation will follow a standard 3+3 design. Treatment duration will not exceed 52 weeks. |
Inhaled mRNA dry powder formulation, administered via a low-resistance dry powder inhaler.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety and Tolerability
기간: From the first dose of study treatment up to 30 days after the last dose.
|
The primary endpoint is to assess the safety and tolerability of inhaled mRNA immunotherapy, including the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
|
From the first dose of study treatment up to 30 days after the last dose.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D)
기간: Up to 28 days after the last dose in each dose cohort.
|
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of inhaled mRNA immunotherapy using a standard 3+3 dose-escalation design.
|
Up to 28 days after the last dose in each dose cohort.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCC6293 (기타 식별자: National Cancer Center/Cancer Hospital, CAMS)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Inhaled mRNA에 대한 임상 시험
-
ModernaTX, Inc.완전한인플루엔자 | 사스 코로나바이러스 2 | RSV영국, 호주, 미국
-
ModernaTX, Inc.완전한코로나바이러스감염증-19 : 코로나19미국, 영국, 캐나다, 일본
-
ModernaTX, Inc.모집하지 않고 적극적으로
-
Judit Pich Martínez완전한
-
ModernaTX, Inc.완전한
-
ModernaTX, Inc.완전한
-
ModernaTX, Inc.완전한