Status:
RECRUITING
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Lead Sponsor:
Nuvalent Inc.
Conditions:
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief 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 activ...
Detailed Description
In Phase 2, study patients will be enrolled into 6 distinct cohorts: * Cohort 2a: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 1 prior 2nd-gener...
Eligibility Criteria
Inclusion Criteria:
-
Age ≥18 years, Phase 2 Cohort 2f only: Age ≥12 years and weighing >40 kg.
-
Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.
-
Phase 2
- Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
- 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.
-
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
-
Adequate organ function and bone marrow reserve
Exclusion criteria:
- Patient's cancer has a known oncogenic driver alteration other than ALK.
- Known allergy/hypersensitivity to excipients of NVL-655.
- Major surgery within 4 weeks of the study entry
- Ongoing or anticancer therapy
- Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT05384626
Start Date
June 9 2022
End Date
January 1 2028
Last Update
October 30 2025
Active Locations (74)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Irvine Medical Center
Orange, California, United States, 92868
2
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
3
Stanford Cancer Institute
Stanford, California, United States, 94305
4
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045