Clinical trial · no report yet · Phase 1/Phase 2
ALKOVE-1
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 ↗
- Recruiting
- Nuvalent Inc.
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- 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)
- Phase
- Phase 1/Phase 2
- Status
- Recruiting
- Conditions
- Locally Advanced Solid Tumor; Metastatic Solid Tumor
- Interventions
- Neladalkib (NVL-655); Midazolam; Repaglinide; Itraconazole
- Arms
- Phase 1 dose escalation · Experimental
- Cohort 2a · Experimental
- Cohort 2b · Experimental
- Cohort 2c · Experimental
- Cohort 2d · Experimental
- Cohort 2e · Experimental
- Cohort 2f · Experimental
- Cohort G (DDI sub-study) · Experimental
- Cohort H (DDI sub-study) · Experimental
- Enrollment
- 840 (estimated)
- Primary outcomes
- Dose limiting toxicities (DLTs) (Phase 1)
- Recommended Phase 2 Dose (RP2D) (Phase 1)
- Objective Response Rate (ORR) (Phase 2)
- Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 1)
- Area under the curve of repaglinide (Phase 2 DDI sub-study)
- Area under the curve of midazolam (Phase 2 DDI sub-study)
- Area under the curve of neladalkib (NVL-655) (Phase 2 DDI sub-study)
- Sponsor
- Nuvalent Inc.
- Start
- Jun 9, 2022
- Primary completion
- Dec 2027 (estimated)
- Results posted
- No
- Registry record
- NCT05384626 · updated May 27, 2026