Clinical Trials List
Protocol NumberNVL-655-01
NCT Number(ClinicalTrials.gov Identfier)NCT05384626
Active
2023-04-01 - 2025-12-31
Phase I/II
Recruiting3
A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jih-Hsiang Lee Division of General Internal Medicine
- 徐偉勛 醫學研究部
- 楊景堯 Division of General Internal Medicine
- 蔡子修 Division of General Internal Medicine
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- 吳尚俊 Division of General Internal Medicine
- JIN-YUAN SHIH Division of General Internal Medicine
- James Chih-Hsin Yang Division of Hematology & Oncology
- Hsin-Yu Liu Division of Ophthalmology
- Chong-Jen Yu Division of General Internal Medicine
- Wei-Wu Chen Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chien-Chung Lin
Co-Principal Investigator
- Chin-Wei Kuo Division of General Internal Medicine
- Yi-Ting Yen Division of General Surgery
- Chian-Wei Chen Division of General Internal Medicine
- Wu-Chou Su Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
- 蔡政軒 Division of General Internal Medicine
- Shang-Yin Wu Division of Hematology & Oncology
- Seu-Chun Yang Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Locally Advanced Solid Tumor、 Metastatic Solid Tumor
Objectives
• Primary:
Phase 1:
(1) Assess the overall safety and tolerability of NVL-655
(2) Determine the recommended Phase 2 dose (RP2D) and (if applicable) maximum tolerated dose (MTD) of NVL-655 for patients with ALK-positive advanced solid tumors
Phase 2: Assess the efficacy of NVL-655 at RP2D in patients with ALK-positive advanced NSCLC (including those with ALK resistance mutations) and other solid tumors
• Secondary:
Phase 1:
(1) Determine the pharmacokinetic profile of NVL-655
(2) Assess the preliminary antitumor activity of NVL-655 in patients with ALK-positive advanced solid tumors
Phase 2:
(1) Assess additional clinical efficacy endpoints in patients with ALK-positive NSCLC (including those with ALK resistance mutations) and other solid tumors
(2) Assess the intracranial antitumor activity of NVL-655 at RP2D in patients with ALK-positive advanced NSCLC and other solid tumors
(3) (4) Understand the safety and tolerability of NVL-655 during RP2D
(5) Confirm the pharmacokinetic profile of NVL-655 during RP2D
(6) Assess treatment-related symptoms and overall health status in patients receiving NVL-655 treatment using a validated patient-reported outcomes (PRO) questionnaire.
Test Drug
膜衣錠
Active Ingredient
NVL-655
Dosage Form
116
Dosage
50 mg
Endpoints
• Phase 1:
(1) Incidence and severity of treatment-emergent adverse events (TEAEs) and clinically significant changes in laboratory parameters during treatment
(2) RP2D and (if applicable) MTD, determined based on the incidence of dose-limiting toxicities (DLTs) during cycle 1, overall safety profile, pharmacodynamics, and preliminary efficacy
• Phase 2: Objective response rate (ORR): defined as the percentage of patients assessed as CR or PR by blinded independent central review (BICR) according to RECIST 1.1
(1) Incidence and severity of treatment-emergent adverse events (TEAEs) and clinically significant changes in laboratory parameters during treatment
(2) RP2D and (if applicable) MTD, determined based on the incidence of dose-limiting toxicities (DLTs) during cycle 1, overall safety profile, pharmacodynamics, and preliminary efficacy
• Phase 2: Objective response rate (ORR): defined as the percentage of patients assessed as CR or PR by blinded independent central review (BICR) according to RECIST 1.1
Inclution Criteria
Inclusion Criteria:
Age ≥18 years, Phase 2 Cohort 2f only: Age ≥12 years and weighing >40 kg.
Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.
Phase 2
Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
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.
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
Adequate organ function and bone marrow reserve
Age ≥18 years, Phase 2 Cohort 2f only: Age ≥12 years and weighing >40 kg.
Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.
Phase 2
Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
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.
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
Adequate organ function and bone marrow reserve
Exclusion Criteria
Exclusion criteria:
Patient's cancer has a known oncogenic driver alteration other than ALK.
Known allergy/hypersensitivity to excipients of NVL-655.
Major surgery within 4 weeks of the study entry
Ongoing or anticancer therapy
Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
Patient's cancer has a known oncogenic driver alteration other than ALK.
Known allergy/hypersensitivity to excipients of NVL-655.
Major surgery within 4 weeks of the study entry
Ongoing or anticancer therapy
Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
The Estimated Number of Participants
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Taiwan
23 participants
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Global
840 participants
