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ALK 양성 NSCLC에 대한 TRI-611의 1/2상 임상시험

2026년 11월 4일 업데이트: TRIANA Biomedicines, Inc.

진행성 ALK 양성 NSCLC 환자를 대상으로 한 경구용 ALK 분자 접착제 분해제 TRI-611의 1/2상 용량 증량 및 확장 연구

The goal of this clinical trial is to learn about the safety and recommended dose of TRI-611 when administered to adults with ALK-positive non-small cell lung cancer (NSCLC). The trial will also evaluate the antitumor activity of TRI-611 in adults with ALK-positive NSCLC.

The study will be conducted in two parts. The first part will examine different doses of TRI-611. The second part will look at how well TRI-611 works on ALK-positive NSCLC when administered to three groups of participants that differ based on what type of prior therapy they have received.

In this study participants will:

  • Take TRI-611 on a continued basis, provided it is well-tolerated, for as long as their disease is not progressing
  • Visit the clinic approximately seven times in the first 3 months and then just once at the start of each 28-day cycle thereafter
  • Keep a diary of each time they take the study medication

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This is a Phase 1/2 dose escalation and dose expansion study designed to evaluate the safety and tolerability of TRI-611, identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in participants with ALK-positive NSCLC.

Part 1 of the study consists of a dose escalation to determine the MTD and/or recommended dose(s) of TRI-611 for further exploration in two backfill cohorts.

Following completion of Part 1 of the study, Part 2 of the study will be initiated. The second part of the study is comprised of three cohorts (M1, M2, M3) of participants differentiated based on their previous treatment with ALK TKIs (tyrosine kinase inhibitors). During this part of the study the antitumor activity of TRI-611 will be further explored. See eligibility criteria for more details.

연구 유형

중재적

등록 (추정된)

160

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • California
      • San Francisco, California, 미국, 94158
        • 모병
        • UCSF
        • 수석 연구원:
          • Collin Blakely, MD
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • 모병
        • University of Colorado Cancer Center
        • 수석 연구원:
          • Kyle Concannon, MD
        • 연락하다:
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
        • 수석 연구원:
          • Jessica Lin, MD
        • 연락하다:
          • Jessica Lin, MD
          • 전화번호: 617-724-4000
          • 이메일: jjlin1@mgb.org
      • Boston, Massachusetts, 미국, 02215
        • 모병
        • Dana Farber Cancer Center
        • 수석 연구원:
          • Alice Shaw, MD
        • 연락하다:
    • Missouri
      • St Louis, Missouri, 미국, 63130
        • 모병
        • Washington University Medical Center
        • 수석 연구원:
          • Saiama Waqar, MD
        • 연락하다:
    • New York
      • New York, New York, 미국, 10065
        • 모병
        • Memorial Sloan-Kettering Cancer Center
        • 수석 연구원:
          • Alexander Drilon, MD
        • 연락하다:
          • Memorial Sloan Kettering Cancer Center
          • 전화번호: 646-608-3758
    • North Carolina
      • Durham, North Carolina, 미국, 27710-2000
        • 모병
        • Duke University
        • 수석 연구원:
          • Thomas Stinchcombe, MD
    • Ohio
      • Cincinnati, Ohio, 미국, 45221
        • 모병
        • University of Cincinnati Cancer Center
        • 수석 연구원:
          • Jennifer Leddon, MD
      • Maumee, Ohio, 미국, 43537
        • 모병
        • Taylor Cancer Research Center
        • 수석 연구원:
          • John Nemunaitis, MD
        • 연락하다:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15213
        • 모병
        • UPMC Hillman Cancer Center
        • 수석 연구원:
          • Lisa Villaruz, MD
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • 모병
        • SCRI Oncology Partners
        • 수석 연구원:
          • Melissa Johnson, MD
        • 연락하다:
    • Texas
      • Houston, Texas, 미국, 77030
        • 모병
        • Oncology Consultants Research (P1 Trials)
        • 수석 연구원:
          • Julio Peguero, MD
        • 연락하다:
    • Utah
      • West Valley City, Utah, 미국, 84119
        • 모병
        • START-Mountain Region
        • 수석 연구원:
          • José Pacheco, MD
        • 연락하다:
    • Virginia
      • Fairfax, Virginia, 미국, 22031
        • 모병
        • NEXT Virginia
        • 수석 연구원:
          • Alexander Spira, MD
  • 영국
      • Sutton, 영국, SM2 5PT
        • 모병
        • The Royal Marsden NHS Foundation
        • 수석 연구원:
          • Anna Minchom, MD
  • 프랑스
      • Lyon, 프랑스, 69008
        • 모병
        • Centre Léon Bérard
        • 수석 연구원:
          • Aurelie Swalduz, MD
      • Villejuif, 프랑스, 94800
        • 모병
        • Gustave Roussy Institute
        • 수석 연구원:
          • Anas Gazzah, MD
  • 호주
    • New South Wales
      • Sydney, New South Wales, 호주, 2000
        • 모병
        • Royal North Shore Hospital
        • 수석 연구원:
          • Malinda Itchins, MD
      • Westmead, New South Wales, 호주, 2145
        • 모병
        • Westmead Hospital
        • 수석 연구원:
          • Adnan Nagrial, MD
    • Victoria
      • Melbourne, Victoria, 호주, 3000
        • 모병
        • Peter MacCallum Cancer Centre
        • 수석 연구원:
          • Ben Solomon, MD

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Pathologically confirmed diagnosis of ALK-positive non-small cell lung cancer (NSCLC)
  • Measurable disease per RECIST v1.1
  • Adequate bone marrow reserve and organ function
  • Part 1: prior treatment with 2 to 3 ALK TKIs [in US only: '2 or more ALK TKIs'], prior treatment with lorlatinib is required but must not have been in the first line
  • Part 2 Cohort M1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line, prior treatment with neladalkib is excluded
  • Part 2 Cohort M2: prior treatment with more than 3 ALK TKIs, prior treatment with lorlatinib and neladalkib is required but neither may have been in the first line
  • Part 2 Cohort M3: participants without prior ALK TKI treatment

Exclusion Criteria:

  • Participant's cancer has any additional driver alterations known to be a mechanism of resistance to ALK TKIs
  • For participants with central nervous system (CNS) metastases or spinal cord compression, they must not be associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease
  • Ongoing treatment with another anticancer treatment or investigational agent
  • Known allergy/hypersensitivity to TRI-611 or any of its ingredients
  • Major surgery within 4 weeks of receiving the first dose of TRI-611

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: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Part 1: Dose Escalation and Backfill

Prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line
의약품: TRI-611

oral ALK molecular glue degrader
실험적: Part 2: Cohort M1

Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded
의약품: TRI-611

oral ALK molecular glue degrader
실험적: Part 2: Cohort M2

Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required
의약품: TRI-611

oral ALK molecular glue degrader
실험적: Part 2: Cohort M3

Participants without prior ALK TKI treatment
의약품: TRI-611

oral ALK molecular glue degrader

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Part 1: Treatment emergent adverse events
기간: Within 28 days of the first TRI-611 dose

Treatment emergent adverse events (TEAEs)
Within 28 days of the first TRI-611 dose
Part 2: Objective response rate (ORR)
기간: Approximately 16 weeks after the last participant dosed in Part 2

Determine the objective response rate (ORR) based on RECIST v1.1
Approximately 16 weeks after the last participant dosed in Part 2
Part 2: Depth of response (DofR)
기간: Approximately 16 weeks after the last participant dosed in Part 2

Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline
Approximately 16 weeks after the last participant dosed in Part 2

2차 결과 측정

결과 측정
측정값 설명
기간
Part 1: Half-life (t1/2) of TRI-611
기간: Pre-dose and up to 24 hours post-dose

Determine the t1/2 of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: Area under the curve (AUC) of TRI-611
기간: Pre-dose and up to 24 hours post-dose

Determine the AUC of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: Maximum plasma concentration (Cmax) of TRI-611
기간: Pre-dose and up to 24 hours post-dose

Determine the Cmax of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: Minimum plasma concentration (Cmin) of TRI-611
기간: Pre-dose and up to 24 hours post-dose

Determine the Cmin of TRI-611
Pre-dose and up to 24 hours post-dose
Part 1: ORR
기간: Approximately 16 weeks after the last participant dosed in Part 1

Determine the ORR based on RECIST v1.1
Approximately 16 weeks after the last participant dosed in Part 1
Part 1: DofR
기간: Approximately 16 weeks after the last participant dosed in Part 1

Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline
Approximately 16 weeks after the last participant dosed in Part 1
Parts 1&2: Duration of response (DOR)
기간: Approximately 5 years after the last participant is dosed with TRI-611

Determine the DOR based on RECIST v1.1
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Disease control rate (DCR)
기간: Approximately 16 weeks after the last participant dosed

Defined as the number and percentage of participants who have achieved a response or stable disease based on RECIST v1.1
Approximately 16 weeks after the last participant dosed
Parts 1&2: Clinical Benefit Rate (CBR)
기간: Approximately 9 months after the last participant is dosed

Defined as the number and percentage of participants who have achieved a response or stable disease based on RECIST v1.1 maintained for a minimum of 6 months
Approximately 9 months after the last participant is dosed
Parts 1&2: Progression-free survival (PFS)
기간: Approximately 5 years after the last participant is dosed with TRI-611

Determine PFS based on RECIST v1.1
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Overall survival (OS)
기간: Approximately 5 years after the last participant is dosed with TRI-611

Determine OS based on RECIST v1.1
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Central Nervous System (CNS) objective response rate (ORR)
기간: Approximately 16 weeks after the last participant dosed

Determine CNS ORR based on modified RECIST (mRECIST v1.1) in participants with CNS metastasis at baseline
Approximately 16 weeks after the last participant dosed
Parts 1&2: CNS duration of response (DOR)
기간: Approximately 5 years after the last participant is dosed with TRI-611

Determine CNS DOR based on mRECIST v1.1 in participants with CNS metastasis at baseline
Approximately 5 years after the last participant is dosed with TRI-611
Parts 1&2: Time to intracranial progression (TTP)
기간: Approximately 5 years after the last participant is dosed with TRI-611

Defined as the time to the date of the first documentation of objective progression of intracranial disease
Approximately 5 years after the last participant is dosed with TRI-611
Part 1: Profile changes in tumor ALK-fusion protein levels
기간: Approximately 14 days after the last dose of participants in Part 1 that have consented to on-treatment biopsies

Assessing treatment-induced modulation of ALK expression only in participants consenting to on-treatment biopsies
Approximately 14 days after the last dose of participants in Part 1 that have consented to on-treatment biopsies

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

TRIANA Biomedicines, Inc.

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 (실제)

2026년 3월 11일

기본 완료 (추정된)

2029년 5월 31일

연구 완료 (추정된)

2034년 1월 30일

연구 등록 날짜

최초 제출

2026년 3월 11일

QC 기준을 충족하는 최초 제출

2026년 3월 19일

처음 게시됨 (실제)

2026년 3월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • TRI-611-101

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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. .

구독하다