A Phase I/II Study of the Selective Inhibitor of Anaplastic Lymphoma Kinase (ALK) NVL 655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
Résumé de l'étude
This clinical study is being conducted to investigate the effects of NVL-655. The study consists of two parts: Phase I and Phase II. It will take place at approximately 70 study centers around the world with about 840 participants (approximately 70 in the first part of Phase I and 70 in the second part of Phase I) and up to 700 participants in Phase II. Approximately 8 participants are expected to receive NVL-655 in Switzerland. The main purpose of Phase I of this study is to determine: • Which dose of NVL-655 is safe and tolerable? • Side effects associated with NVL-655 • How much NVL-655 enters the bloodstream and how long it takes for the body to eliminate it (investigated through blood samples)? • The effect of NVL-655 on your tumor (tumor imaging). The main purpose of Phase II of this study is to determine: • Whether NVL-655 is effective in shrinking tumors, and if so, how long the response to NVL-655 lasts. • Further insights regarding side effects associated with NVL-655 • How much NVL-655 enters the bloodstream and how long it takes for the body to eliminate NVL-655.
(BASEC)
Intervention étudiée
Phase 1: Dose escalation 15-200 mg/qd. Dose escalation includes patients with locally advanced or metastatic solid tumors that have an ALK rearrangement or an activating mutation. Phase 2: This part of the study will include 6 cohorts. The dosing will be adjusted as deemed appropriate for testing in the Phase 2 part (per cohort) of the study by the investigators and the sponsor, per patient.
(BASEC)
Maladie en cours d'investigation
Advanced Non-Small Cell Lung Cancer and Other Solid Tumors
(BASEC)
Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or an activating ALK mutation. Patients whose disease is refractory or resistant to available therapies for their respective malignancy or for whom current therapy is unlikely to provide benefit. There must be measurable disease defined as ≥1 radiologically measurable target lesion according to RECIST 1.1. (BASEC)
Critères d'exclusion
The patient's cancer has another known oncogenic driver alteration other than ALK. Major surgery within 4 weeks prior to the first dose of the study drug. Uncontrolled clinically significant bacterial or fungal infection requiring systemic therapy. The patient has CNS metastases or a primary CNS tumor associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease. (BASEC)
Lieu de l’étude
Bellinzona, Luzern
(BASEC)
Sponsor
Sponsor: Nuvalent Inc., Cambridge, Massachusetts USA Vertreter des Sponsors in der Schweiz: Quartz Bio SA, Genf
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. med. Anna Allemann
+41 41 205 5860 (Sekretariat)
annateresa.allemann@clutterluks.chLeitende Ärztin Medizinische Onkologie FMH Innere Medizin und Medizinische Onkologie Luzerner Kantonsspital | Tumorzentrum
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
30.07.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT05384626 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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) (BASEC)
Titre académique
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) (ICTRP)
Titre public
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1) (ICTRP)
Maladie en cours d'investigation
Locally Advanced Solid TumorMetastatic Solid Tumor (ICTRP)
Intervention étudiée
Drug: Neladalkib (NVL-655) (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
1. Age =18 years, Phase 2 Cohort 2f only: Age =12 years and weighing >40 kg.
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. 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
5. 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. (ICTRP)
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Critères d'évaluation principaux et secondaires
Dose limiting toxicities (DLTs) (Phase 1);Recommended Phase 2 Dose (RP2D) (Phase 1);Objective Response Rate (ORR) (Phase 2);Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 1) (ICTRP)
Maximum plasma concentration, (Cmax) of neladalkib (NVL-655);Plasma concentration at the end of the dosing interval (Ctau) of neladalkib (NVL-655);Average plasma concentration (Cavg) of neladalkib (NVL-655);Time of maximum concentration (Tmax) of neladalkib (NVL-655);Area under the curve at the end of the dosing interval (AUCtau) of neladalkib (NVL-655);Area under the curve from time 0 to 24 (AUC0-24) of neladalkib (NVL-655);Area under the curve from time 0 to infinity (AUCinf) of neladalkib (NVL-655);Oral clearance (CL/F) of neladalkib (NVL-655);Volume of distribution (Vz/F) of neladalkib (NVL-655);Half-life (t1/2) of neladalkib (NVL-655);Objective response rate (ORR) (Phase 1);Duration of response (DOR);Clinical benefit rate (CBR);Time to response;Progression-free survival (PFS);Overall survival (OS) (Phase 2);Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 2);Quality of life assessment (ICTRP)
Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
Viola Zhu, MD, PHD;Tina Kehrig, clinicaltrials@nuvalent.com, 857-357-7000, Nuvalent Inc., (ICTRP)
ID secondaires
NVL-655-01 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT05384626 (ICTRP)
Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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