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)

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514266-39-00

Acronym

NVL-655-01

Enrollment

350

Registered

2024-11-04

Start date

2022-11-03

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors with ALK rearrangement or activating ALK mutation

Brief summary

Phase 1 - Incidence and severity of TEAEs and changes in clinically relevant laboratory parameters, Phase 1 - RP2D and, if applicable, the MTD, Phase 2 - ORR according to RECIST 1.1

Detailed description

Phase 1 - PK parameters of NVL-655, Phase 1 - ORR according to RECIST 1.1 assessment, Phase 2 - DOR, Phase 2 - IC-ORR, Phase 2 - Incidence and severity of TEAEs and changes in clinically relevant laboratory parameters, Phase 2 - PK parameters of NVL-655, Phase 2 - Changes in PROs

Interventions

DRUGNVL-655

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 1 - Incidence and severity of TEAEs and changes in clinically relevant laboratory parameters, Phase 1 - RP2D and, if applicable, the MTD, Phase 2 - ORR according to RECIST 1.1	—

Secondary

Measure	Time frame
Phase 1 - PK parameters of NVL-655, Phase 1 - ORR according to RECIST 1.1 assessment, Phase 2 - DOR, Phase 2 - IC-ORR, Phase 2 - Incidence and severity of TEAEs and changes in clinically relevant laboratory parameters, Phase 2 - PK parameters of NVL-655, Phase 2 - Changes in PROs	—

Countries

Belgium, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026