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ALK 재배열 또는 활성화 ALK 돌연변이(ALKOVE-1)가 있는 진행성 NSCLC 및 기타 고형 종양 환자에서 NVL-655에 대한 연구

2026년 11월 4일 업데이트: Nuvalent Inc.

진행성 NSCLC 및 기타 고형 종양(ALKOVE-1) 환자의 선택적 역형성 림프종 키나제(ALK) 억제제 NVL-655에 대한 1/2상 연구

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors.

Phase 1 will evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors.

Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors.

A drug-drug interaction (DDI) sub-study will determine the effect of neladalkib on the pharmacokinetics of midazolam and repaglinide, as well as the effect of itraconazole on the pharmacokinetics of neladalkib, in patients with advanced ALK-positive NSCLC

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

In Phase 2, study patients will be enrolled into 6 distinct cohorts:

  • Cohort 2a: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 1 prior 2nd-generation ALK TKI (ceritinib, alectinib, or brigatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed.
  • Cohort 2b: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received 2-3 prior ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed.
  • Cohort 2c: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received lorlatinib as the only prior ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy received prior to lorlatinib is allowed.
  • Cohort 2d: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who are naïve to ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy is allowed.
  • Cohort 2e: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, not eligible for other Phase 2 cohorts.
  • Cohort 2f: Patients with other solid tumors harboring an ALK rearrangement or activating ALK mutation, who have received ≥1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists.

In the DDI sub-study, study patients will be enrolled into 2 distinct cohorts:

  • Cohort G (DDI sub-study with midazolam and repaglinide): Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received ≥1 prior ALK TKI.
  • Cohort H (DDI sub-study with itraconazole): Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received ≥1 prior ALK TKI.

연구 유형

중재적

등록 (추정된)

840

단계

  • 2 단계
  • 1단계

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연락처 및 위치

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

연구 연락처

연구 장소

  • 네덜란드
      • Amsterdam, 네덜란드, 1066 CX
        • 모병
        • The Netherlands Cancer Institute
        • 수석 연구원:
          • Adrianus Joop de Langen, MD
      • Groningen, 네덜란드, 9713 GZ
        • 모병
        • University Medical Center Groningen (UMCG)
        • 수석 연구원:
          • AJ Van Der Wekken, MD
  • 대만
      • Taichung, 대만, 402306
        • 모병
        • Chung-Shan Medical University Hospital
        • 수석 연구원:
          • Gee-Chen Chang, MD
      • Tainan, 대만, 70403
        • 모병
        • National Cheng Kung University Hospital
        • 수석 연구원:
          • Chien-Chung Lin, MD
      • Taipei, 대만, 10002
        • 모병
        • National Taiwan University Hospital
        • 수석 연구원:
          • Josh Lin, MD
  • 대한민국
      • Seoul, 대한민국, 03080
        • 모병
        • Seoul National University Hospital
        • 수석 연구원:
          • Dong-wan Kim, MD
      • Seoul, 대한민국, 06351
        • 모병
        • Samsung Medical Center
        • 수석 연구원:
          • Myung-Ju Ahn, MD
      • Seoul, 대한민국, 03722
        • 모병
        • Severance Hospital Yonsei University Health System
        • 수석 연구원:
          • Byoung Chul Cho, MD
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, 대한민국, 10408
        • 모병
        • National Cancer Center
        • 수석 연구원:
          • Ji-Youn Han, MD
  • 독일
      • Cologne, 독일, 50937
        • 모병
        • Universitatsklinikum Koln - University Hospital Cologne
        • 수석 연구원:
          • Dr med Sebastian Michels
      • Frankfurt, 독일, 60590
        • 모병
        • Universitätsklinikum Frankfurt
        • 수석 연구원:
          • Martin Sebastian, MD
      • Großhansdorf, 독일, 22927
        • 모병
        • LungenClinic Grosshansdorf GmbH
        • 수석 연구원:
          • Prof Dr Martin Reck
      • Heidelberg, 독일, 69126
        • 모병
        • Universkitatsklinikum Heidelberg - University Hospital Heidelberg
        • 수석 연구원:
          • Prof Dr med Petros Christopoulos
  • 미국
    • California
      • Orange, California, 미국, 92868
        • 모병
        • University of California Irvine Medical Center
        • 수석 연구원:
          • Misako Nagasaka, MD
      • Sacramento, California, 미국, 95817
        • 모병
        • University of California, Davis Comprehensive Cancer Center
        • 수석 연구원:
          • Jonathan Riess, MD
      • Stanford, California, 미국, 94305
        • 모병
        • Stanford Cancer Institute
        • 수석 연구원:
          • Joel Neal, MD, PhD
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • 모병
        • University of Colorado Cancer Center
        • 수석 연구원:
          • Ross Camidge, MD, PhD
    • District of Columbia
      • Washington D.C., District of Columbia, 미국, 20007
        • 모병
        • Georgetown University Medical Center
        • 수석 연구원:
          • Joshua Reuss, MD
    • Florida
      • Miami, Florida, 미국, 33136
        • 모병
        • University of Miami; Sylvester Cancer Center
        • 수석 연구원:
          • Gilberto de Lima Lopes, MD
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • 모병
        • Winship Cancer Institute, Emory University
        • 수석 연구원:
          • Ticiana Leal, MD
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • 모병
        • University of Chicago Medical Center
        • 수석 연구원:
          • Marina Garassino, MD
    • Maryland
      • Baltimore, Maryland, 미국, 21224
        • 모병
        • John Hopkins University
        • 수석 연구원:
          • Vincent Lam, MD
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
        • 수석 연구원:
          • Jessica Lin, MD
      • Boston, Massachusetts, 미국, 02215
        • 모병
        • Dana Farber Cancer Institute
        • 수석 연구원:
          • Alice Shaw, MD
    • Michigan
      • Detroit, Michigan, 미국, 48202
        • 모병
        • Henry Ford Cancer Institute
        • 수석 연구원:
          • Bindu Potugari, MD
    • Missouri
      • St Louis, Missouri, 미국, 63310
        • 모병
        • Washington University School of Medicine Siteman Cancer Center
        • 수석 연구원:
          • Saiama Waqar, MD
    • New York
      • New York, New York, 미국, 10065
        • 모병
        • Memorial Sloan Kettering Cancer Center
        • 수석 연구원:
          • Alexander Drilon, MD
      • New York, New York, 미국, 10016
        • 모병
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
        • 수석 연구원:
          • Elaine Shum, MD
    • North Carolina
      • Durham, North Carolina, 미국, 27705
        • 모병
        • Duke University Medical Center
        • 수석 연구원:
          • Thomas Stinchcombe, MD
    • Ohio
      • Columbus, Ohio, 미국, 43210
        • 모병
        • OSU Brain & Spine Hospital
        • 수석 연구원:
          • Logan Roof, MD, MSCR
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • 모병
        • University of Pennsylvania, Abramson Cancer Center
        • 수석 연구원:
          • Charu Aggarwal, MD
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • 모병
        • Sarah Cannon
        • 수석 연구원:
          • Melissa Johnson, MD
    • Texas
      • Houston, Texas, 미국, 77030
        • 모집하지 않고 적극적으로
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, 미국, 98109
        • 모병
        • Fred Hutchinson Cancer Center
        • 수석 연구원:
          • Christina Baik, MD, MPH
  • 벨기에
      • Antwerp, 벨기에, 2650
        • 모병
        • Universitair Ziekenhuis Antwerpen (UZA)
        • 수석 연구원:
          • Reinier Wener, MD
      • Leuven, 벨기에, 3000
        • 모병
        • Universitaire Ziekenhuizen Leuven Campus Gastthuisberg
        • 수석 연구원:
          • Christophe Dooms, MD
  • 스위스
      • Bellinzona, 스위스, 6500
        • 모병
        • Istituto Oncologico Svizzera Italiana
        • 수석 연구원:
          • Patrizia Froesch, MD
      • Lucerne, 스위스, 6000
        • 모병
        • Luzerner Kantonsspital
        • 수석 연구원:
          • Anna Allemann, MD
  • 스페인
      • A Coruña, 스페인, 15006
        • 모병
        • Complejo Hospitalario Universitario de A Coruna
        • 수석 연구원:
          • Maria Campelo, MD
      • Barcelona, 스페인, 08035
        • 모병
        • Vall d'Hebron
        • 수석 연구원:
          • Enriqueta Felip, Md, PhD
      • Barcelona, 스페인, 08017
        • 모병
        • UOMI Cancer Center
        • 수석 연구원:
          • Santiago Viteri Ramirez, MD PhD
      • Madrid, 스페인, 28041
        • 모병
        • Hospital Universitario 12 de Octubre
        • 수석 연구원:
          • Luis Paz Ares, MD, PhD
      • Madrid, 스페인, 28009
        • 모병
        • Hospital General Universitario Gregorio Maranon
        • 수석 연구원:
          • Antonio Calles, MD
  • 싱가포르
    • Singapore
      • Singapore, Singapore, 싱가포르, 119074
        • 모병
        • National University Hospital
        • 수석 연구원:
          • Ross Soo, MD
      • Singapore, Singapore, 싱가포르, 168583
        • 모병
        • National Cancer Centre Singapore
        • 수석 연구원:
          • Aaron Tan, MD
  • 영국
      • Edinburgh, 영국, EH4 2XU
        • 모병
        • Edinburgh Cancer Centre
        • 수석 연구원:
          • Colin Barrie, MD
      • London, 영국, SM2 5PT
        • 모병
        • The Royal Marsden - Chelsea
        • 수석 연구원:
          • Sanjay Popat MD
      • Manchester, 영국, M20 4BX
        • 모병
        • The Christie NHS Foundation Trust
        • 수석 연구원:
          • Matthew Krebs, MB ChB PhD
    • Surrey
      • Sutton, Surrey, 영국, SM2 5PT
        • 모병
        • Royal Marsden Hospital
        • 수석 연구원:
          • Sanjay Popat MD
  • 이탈리아
      • Ancona, 이탈리아, 60126
        • 모병
        • Azienda Ospedaliera Universitaria Ospedali Riuniti Umberto
        • 수석 연구원:
          • Rossana Berardi, MD
      • Bari, 이탈리아, 70124
        • 모병
        • IRCCS Istituto Tumori "G. Paolo II"
        • 수석 연구원:
          • Domenico Galetta, MD
      • Milan, 이탈리아, 20133
        • 모병
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • 수석 연구원:
          • Sara Cresta, MD
      • Milan, 이탈리아, 20141
        • 모병
        • Instituto Europeo di Oncologia
        • 수석 연구원:
          • Gianluca Spitaleri, MD
      • Padova, 이탈리아, 35128
        • 모병
        • Instituto Oncologico Veneto
        • 수석 연구원:
          • Giulia Pasello, MD
      • Ravenna, 이탈리아, 48100
        • 모병
        • Ospedale Santa Maria delle Croci
        • 수석 연구원:
          • Chiara Bennati, MD
      • Rome, 이탈리아, 00144
        • 모병
        • Regina Elena Institute for Cancer Research
        • 수석 연구원:
          • Lorenza Landi, MD
  • 일본
      • Kanagawa, 일본, 2418515
        • 모병
        • Kanagawa Cancer Center
        • 수석 연구원:
          • Tetsuro Kondo, MD
      • Okayama, 일본, 7008558
        • 모병
        • Okayama University Hospital
        • 수석 연구원:
          • Kiichiro Ninomiya, MD
      • Osaka, 일본, 5898511
        • 모병
        • Kindai University Hospital
        • 수석 연구원:
          • Junko Tanizaki, MD
      • Shizuoka, 일본, 4118777
        • 모병
        • Shizuoka Cancer Center
        • 수석 연구원:
          • Ryo Ko, MD PhD
      • Tokyo, 일본, 1040051
        • 모병
        • National Cancer Center Hospital
        • 수석 연구원:
          • Tatsuya Yoshida, MD
      • Tokyo, 일본, 1358550
        • 모병
        • Cancer Institute Hospital of JFCR
        • 수석 연구원:
          • Ryo Ariyasu, MD
      • Wakayama, 일본, 6418510
        • 모병
        • Wakayama Medical University Hospital
        • 수석 연구원:
          • Hiroaki Akamatsu, MD, PhD
  • 캐나다
    • Alberta
      • Edmonton, Alberta, 캐나다, T6G 1Z2
        • 모병
        • Cross Cancer Institute
        • 수석 연구원:
          • Quincy Siu Chung Chu, MD
    • British Columbia
      • Vancouver, British Columbia, 캐나다, VZ 4E6
        • 모병
        • BC Cancer Center
        • 수석 연구원:
          • Jamie Feng, MD
    • Ontario
      • Ottawa, Ontario, 캐나다, K1H 8L6
        • 모병
        • The Ottawa Hospital Cancer Center
        • 수석 연구원:
          • Garth Nicholas, MD
      • Toronto, Ontario, 캐나다, M5G 0A3
        • 모병
        • Princess Margaret Cancer Centre
        • 수석 연구원:
          • Geoffrey Liu, M.D.
  • 프랑스
      • Lyon, 프랑스, 69373
        • 모병
        • Centre Leon Berard
        • 수석 연구원:
          • Aurelie Swalduz, MD
      • Nantes, 프랑스, 44093
        • 모병
        • Chu De Nantes
        • 수석 연구원:
          • Elvire Pons-Tostivint, MD, PhD
      • Toulouse, 프랑스, 31059
        • 모병
        • Institut Claudius Regaud
        • 수석 연구원:
          • Julien Mazieres, MD, PhD
      • Villejuif, 프랑스, 94805
        • 모병
        • Institute Gustave Roussy
        • 수석 연구원:
          • Benjamin Besse, MD, PhD
  • 호주
    • New South Wales
      • Sydney, New South Wales, 호주, 2065
        • 모병
        • Royal North Shore Hospital
        • 수석 연구원:
          • Malinda Itchins, MBBS PhD
    • Queensland
      • Woolloongabba, Queensland, 호주, 4102
        • 모병
        • Princess Alexandra Hospital
        • 수석 연구원:
          • Kenneth O'Byrne, MD
    • Victoria
      • Melbourne, Victoria, 호주, 3000
        • 모병
        • Peter MacCallum Cancer Centre
        • 수석 연구원:
          • Benjamin Solomon, MD, PhD

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

12년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Age ≥18 years, Phase 2 Cohort 2f only: Age ≥12 years and weighing >40 kg. DDI sub-study Cohorts G and H only: age 18-60 years, inclusive

  2. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.

  3. Phase 2

    1. Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
    2. Phase 2 Cohort 2f: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation detected by certified assay.

  4. DDI sub-study cohorts: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement

  5. DDI sub-study cohorts: Must have previously received ≥1 ALK TKI; no prior investigational agents targeting ALK; any number of prior chemotherapy and/or immunotherapy

  6. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1 Phase 2: Must have measurable disease according to RECIST 1.1

  7. Adequate organ function and bone marrow reserve

Exclusion criteria:

  1. Patient's cancer has a known oncogenic driver alteration other than ALK.
  2. Known allergy/hypersensitivity to excipients of NVL-655.
  3. Major surgery within 4 weeks of the study entry
  4. Ongoing or anticancer therapy
  5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

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: Phase 1 dose escalation

Neladalkib (NVL-655) oral daily dosing
의약품: Neladalkib (NVL-655)

Oral Tablet of Neladalkib (NVL-655)
실험적: Cohort 2a

Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 1 prior 2nd-generation ALK TKI (ceritinib, alectinib, or brigatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed.
의약품: Neladalkib (NVL-655)

Oral Tablet of Neladalkib (NVL-655)
실험적: Cohort 2b

Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received 2-3 prior ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed.
의약품: Neladalkib (NVL-655)

Oral Tablet of Neladalkib (NVL-655)
실험적: Cohort 2c

Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received lorlatinib as the only prior ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy received prior to lorlatinib is allowed.
의약품: Neladalkib (NVL-655)

Oral Tablet of Neladalkib (NVL-655)
실험적: Cohort 2d

Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who are naïve to ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy is allowed.
의약품: Neladalkib (NVL-655)

Oral Tablet of Neladalkib (NVL-655)
실험적: Cohort 2e

Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, not eligible for other Phase 2 cohorts.
의약품: Neladalkib (NVL-655)

Oral Tablet of Neladalkib (NVL-655)
실험적: Cohort 2f

Patients with other solid tumors harboring an ALK rearrangement or activating ALK mutation, who have received ≥1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists.
의약품: Neladalkib (NVL-655)

Oral Tablet of Neladalkib (NVL-655)
실험적: Cohort G (DDI sub-study)

Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received ≥1 prior ALK TKI
의약품: Neladalkib (NVL-655)

Oral Tablet of Neladalkib (NVL-655)

의약품: Midazolam

Oral Solution of Midazolam

의약품: Repaglinide

Oral Tablet of Repaglinide
실험적: Cohort H (DDI sub-study)

Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received ≥1 prior ALK TKI
의약품: Neladalkib (NVL-655)

Oral Tablet of Neladalkib (NVL-655)

의약품: Itraconazole

Oral Solution of Itraconazole

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate (ORR) (Phase 2)
기간: 2-3 years after first patient dosed.

To determine ORR as assessed by BICR
2-3 years after first patient dosed.
Dose limiting toxicities (DLTs) (Phase 1)
기간: Within the first 21 days of the first neladalkib (NVL-655) dose

Define the dose limiting toxicities (DLTs)
Within the first 21 days of the first neladalkib (NVL-655) dose
Recommended Phase 2 Dose (RP2D) (Phase 1)
기간: Within 21 days of last patient dosed during escalation

To determine the RP2D
Within 21 days of last patient dosed during escalation
Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 1)
기간: Approximately 3 years

Incidence and severity of treatment-emergent adverse events (TEAEs)
Approximately 3 years
Area under the curve of repaglinide (Phase 2 DDI sub-study)
기간: Pre-dose and up to 24 hours post-dose

To determine the effect of multiple oral doses of neladalkib (NVL-655) on the PK of a single oral dose of repaglinide
Pre-dose and up to 24 hours post-dose
Area under the curve of midazolam (Phase 2 DDI sub-study)
기간: Pre-dose and up to 24 hours post-dose

To determine the effect of multiple oral doses of neladalkib (NVL-655) on the PK of a single oral dose of midazolam
Pre-dose and up to 24 hours post-dose
Area under the curve of neladalkib (NVL-655) (Phase 2 DDI sub-study)
기간: Pre-dose and up to 24 hours post-dose

To determine the effect of itraconazole on the single oral dose PK of neladalkib (NVL-655)
Pre-dose and up to 24 hours post-dose

2차 결과 측정

결과 측정
측정값 설명
기간
Maximum plasma concentration, (Cmax) of neladalkib (NVL-655)
기간: Pre-dose and up to 24 hours post-dose

To determine the maximum plasma concentration (Cmax) of neladalkib (NVL-655)
Pre-dose and up to 24 hours post-dose
Plasma concentration at the end of the dosing interval (Ctau) of neladalkib (NVL-655)
기간: Pre-dose and up to 24 hours post-dose

To determine the plasma concentration at the end of the dosing interval (Ctau) of neladalkib (NVL-655)
Pre-dose and up to 24 hours post-dose
Average plasma concentration (Cavg) of neladalkib (NVL-655)
기간: Pre-dose and up to 24 hours post-dose

To determine the average plasma concentration (Cavg) of neladalkib (NVL-655)
Pre-dose and up to 24 hours post-dose
Time of maximum concentration (Tmax) of neladalkib (NVL-655)
기간: Pre-dose and up to 24 hours post-dose

To determine the time of maximum concentration (Tmax) of neladalkib (NVL-655)
Pre-dose and up to 24 hours post-dose
Area under the curve at the end of the dosing interval (AUCtau) of neladalkib (NVL-655)
기간: Pre-dose and up to 24 hours post-dose

To determine the area under the curve at the end of the dosing interval (AUCtau) of neladalkib (NVL-655)
Pre-dose and up to 24 hours post-dose
Area under the curve from time 0 to 24 (AUC0-24) of neladalkib (NVL-655)
기간: Pre-dose and up to 24 hours post-dose

To determine the area under the curve from time 0 to 24 (AUC0-24) of neladalkib (NVL-655)
Pre-dose and up to 24 hours post-dose
Area under the curve from time 0 to infinity (AUCinf) of neladalkib (NVL-655)
기간: Pre-dose and up to 24 hours post-dose

To determine the area under the curve from time 0 to infinity (AUCinf) of neladalkib (NVL-655)
Pre-dose and up to 24 hours post-dose
Oral clearance (CL/F) of neladalkib (NVL-655)
기간: Pre-dose and up to 24 hours post-dose

To determine the oral clearance (CL/F) of neladalkib (NVL-655)
Pre-dose and up to 24 hours post-dose
Volume of distribution (Vz/F) of neladalkib (NVL-655)
기간: Pre-dose and up to 24 hours post-dose

To determine the volume of distribution (Vz/F) of neladalkib (NVL-655)
Pre-dose and up to 24 hours post-dose
Half-life (t1/2) of neladalkib (NVL-655)
기간: Pre-dose and up to 24 hours post-dose

To determine the half-life (t1/2) of neladalkib (NVL-655)
Pre-dose and up to 24 hours post-dose
Objective response rate (ORR) (Phase 1)
기간: 2-3 years after first patient dosed

Determine ORR as assessed by Investigator
2-3 years after first patient dosed
Duration of response (DOR)
기간: 2-3 years after first patient dosed

Determine DOR of neladalkib (NVL-655) until radiographic disease progression or death
2-3 years after first patient dosed
Clinical benefit rate (CBR)
기간: 2-3 years after first patient dosed

Determine CBR of neladalkib (NVL-655)
2-3 years after first patient dosed
Time to response
기간: Approximately 3 years

Determine time to response of neladalkib (NVL-655)
Approximately 3 years
Progression-free survival (PFS)
기간: 2-3 years after first patient dosed

Determine PFS of neladalkib (NVL-655) until radiographic disease progression or death
2-3 years after first patient dosed
Overall survival (OS) (Phase 2)
기간: Approximately 3 years

Determine OS
Approximately 3 years
Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 2)
기간: Approximately 3 years

Incidence and severity of treatment-emergent adverse events (TEAEs)
Approximately 3 years
Quality of life assessment
기간: 2-3 years after first patient dosed

Measure the quality of life in patients with cancer and/or lung cancer.
2-3 years after first patient dosed
Incidence and severity of AEs and incidence of abnormalities across laboratory values, ECGs, vital signs, and physical examinations (Phase 2 DDI-sub-study)
기간: Up to 3 months after last dose

Assess the safety and tolerability of neladalkib (NVL-655) when co-administered with repaglinide or midazolam
Up to 3 months after last dose
Incidence and severity of AEs and incidence of abnormalities across laboratory values, ECGs, vital signs, and physical examinations (Phase 2 DDI-sub-study)
기간: Up to 3 months after last dose

Assess the safety and tolerability of neladalkib (NVL-655) when co-administered with itraconazole
Up to 3 months after last dose

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Nuvalent Inc.

수사관

  • 연구 책임자: Viola Zhu, MD, PHD, Nuvalent 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)

2022년 6월 9일

기본 완료 (추정된)

2027년 12월 1일

연구 완료 (추정된)

2028년 1월 1일

연구 등록 날짜

최초 제출

2022년 5월 17일

QC 기준을 충족하는 최초 제출

2022년 5월 17일

처음 게시됨 (실제)

2022년 5월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NVL-655-01

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. .

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