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Clinical Trials in Spain / NCT05384626
Recruiting Phase 1/2

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

NCT05384626 · tracked via the Priya Life Science Spain tracker
Sponsor
Nuvalent Inc
Phase
Phase 1/2
Started
2022-06-09
Last updated
2026-05-27

Condition(s) studied

Locally Advanced Solid TumorMetastatic Solid Tumor

Investigational drug(s) / intervention(s)

Neladalkib (NVL-655) →Midazolam →Repaglinide →Itraconazole →

Neladalkib (NVL-655): Oral Tablet of Neladalkib (NVL-655)

Midazolam: Oral Solution of Midazolam

Repaglinide: Oral Tablet of Repaglinide

Itraconazole: Oral Solution of Itraconazole

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Dose limiting toxicities (DLTs) (Phase 1) — Within the first 21 days of the first neladalkib (NVL-655) dose
    Define the dose limiting toxicities (DLTs)
  • Recommended Phase 2 Dose (RP2D) (Phase 1) — Within 21 days of last patient dosed during escalation
    To determine the RP2D
  • Objective Response Rate (ORR) (Phase 2) — 2-3 years after first patient dosed.
    To determine ORR as assessed by BICR
  • Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 1) — Approximately 3 years
    Incidence and severity of treatment-emergent adverse events (TEAEs)
  • Area under the curve of repaglinide (Phase 2 DDI sub-study) — 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
  • Area under the curve of midazolam (Phase 2 DDI sub-study) — 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
  • Area under the curve of neladalkib (NVL-655) (Phase 2 DDI sub-study) — 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)

Trial sites (74)

FacilityCityRegionStatus
University of California Irvine Medical Center Orange California Recruiting
University of California, Davis Comprehensive Cancer Center Sacramento California Recruiting
Stanford Cancer Institute Stanford California Recruiting
University of Colorado Cancer Center Aurora Colorado Recruiting
Georgetown University Medical Center Washington D.C. District of Columbia Recruiting
University of Miami; Sylvester Cancer Center Miami Florida Recruiting
Winship Cancer Institute, Emory University Atlanta Georgia Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
John Hopkins University Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Henry Ford Cancer Institute Detroit Michigan Recruiting
Washington University School of Medicine Siteman Cancer Center St Louis Missouri Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Duke University Medical Center Durham North Carolina Recruiting
OSU Brain & Spine Hospital Columbus Ohio Recruiting
University of Pennsylvania, Abramson Cancer Center Philadelphia Pennsylvania Recruiting
Sarah Cannon Nashville Tennessee Recruiting
MD Anderson Cancer Center Houston Texas Active Not Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Royal North Shore Hospital Sydney New South Wales Recruiting
Princess Alexandra Hospital Woolloongabba Queensland Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
Universitair Ziekenhuis Antwerpen (UZA) Antwerp Belgium Recruiting
Universitaire Ziekenhuizen Leuven Campus Gastthuisberg Leuven Belgium Recruiting
Cross Cancer Institute Edmonton Alberta Recruiting
BC Cancer Center Vancouver British Columbia Recruiting
The Ottawa Hospital Cancer Center Ottawa Ontario Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
Centre Leon Berard Lyon France Recruiting
Chu De Nantes Nantes France Recruiting
Institut Claudius Regaud Toulouse France Recruiting
Institute Gustave Roussy Villejuif France Recruiting
Universitatsklinikum Koln - University Hospital Cologne Cologne Germany Recruiting
Universitätsklinikum Frankfurt Frankfurt Germany Recruiting
LungenClinic Grosshansdorf GmbH Großhansdorf Germany Recruiting
Universkitatsklinikum Heidelberg - University Hospital Heidelberg Heidelberg Germany Recruiting
Azienda Ospedaliera Universitaria Ospedali Riuniti Umberto Ancona Italy Recruiting
IRCCS Istituto Tumori "G. Paolo II" Bari Italy Recruiting

+ 34 more sites — see the full list on the official registry below.

More Nuvalent Inc. trials in Spain

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) Recruiting
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC Recruiting

Other trials for the same condition

A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors Recruiting
Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors Active, not recruiting
A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies Active, not recruiting
A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer Recruiting
Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05384626 on ClinicalTrials.gov ↗ ← All trials in Spain