Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 1/Phase 2
Nuvalent Inc. (Voir sur ClinicalTrials)
juin 2022
janvier 2028
02 novembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin BESSE | 13/06/2024 07:41:55 | Contacter | ||
Critères
Tous
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.