Clinical trial · no report yet · Phase 1/Phase 2
NCT05384626
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.
- 3 commentary sources found
- 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.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built. Commentary is thin so far, so the report would be short.
| 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