A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
← catalyst calendarNCT05384626 · readout ≤ 499 d
Sponsored by Nuvalent Inc. (industry) · NUVL — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
840estimated
Sites
74
Countries
Australia, Belgium, Canada +12
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-06-09 | actual | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2022-05-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Locally Advanced Solid Tumor
- Metastatic Solid Tumor
Interventions
- Drug: Neladalkib (NVL-655)
- Drug: Midazolam
- Drug: Repaglinide
- Drug: Itraconazole
Primary outcomes
what the primary-completion date above is the date OFDose limiting toxicities (DLTs) (Phase 1)
measured Within the first 21 days of the first neladalkib (NVL-655) dose
Recommended Phase 2 Dose (RP2D) (Phase 1)
measured Within 21 days of last patient dosed during escalation
Objective Response Rate (ORR) (Phase 2)
measured 2-3 years after first patient dosed.
Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 1)
measured Approximately 3 years
Area under the curve of repaglinide (Phase 2 DDI sub-study)
measured Pre-dose and up to 24 hours post-dose
Area under the curve of midazolam (Phase 2 DDI sub-study)
measured Pre-dose and up to 24 hours post-dose
Area under the curve of neladalkib (NVL-655) (Phase 2 DDI sub-study)
measured Pre-dose and up to 24 hours post-dose
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