Overview

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

Status:
Not yet recruiting
Trial end date:
2026-03-01
Target enrollment:
0
Participant gender:
All
Summary
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of 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 determine the RP2D and, if applicable, the MTD of NVL-655 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 NVL-655 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 NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nuvalent Inc.
Criteria
Inclusion Criteria:

1. Age ≥18 years Phase 2 Cohort 2d 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. Cohorts 2a, 2b, and 2c: Histologically or cytologically confirmed locally
advanced or metastatic NSCLC with a documented ALK rearrangement

2. Cohort 2d: histologically or cytologically confirmed locally advanced or
metastatic solid tumor with a documented ALK rearrangement or activating ALK
mutation

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.