ALKOVE-1: This phase I/II study is evaluating how safe, tolerable and effective a new cancer drug (NVL-655) is in people with advanced ALK-positive (ALK+) non-small cell lung cancer, and other solid cancersA 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)

Trial purpose

Cancer treatment

Tumor type

Multi-Cancer

Age

12+

Trial acronym

ALKOVE-1

Summary

This study has two phases. Phase 1 (dose escalation) will determine the recommended phase 2 dose (RP2D) and, if applicable, maximum tolerated dose (MTD) of NVL-655 in people with ALK+ solid cancers. NVL-655 will be given daily via oral tablet. Phase 2 (dose expansion) will determine further assess the safety and effectiveness of NVL-655 and will consist of four cohorts. Cohort 2a will recruit people with ALK+ non-small cell lung cancer (NSCLC) who have received 1 prior 2nd generation ALK TKI (ceritinib, alectinib, brigatinib). Cohort 2b will recruit people with ALK+ NSCLC who have received 2-3 prior 1st or 2nd-generation ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib). Cohort 2c will recruit people with ALK+ NSCLC who have received 2-3 prior ALK TKIs, with lorlatinib in the 2nd or 3rd line. Cohort 2d will recruit people with ALK+ solid cancers, including people with NSCLC who are not eligible for cohorts 2a-c, who have received ≥1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists.

Conditions

This trial is treating patients with ALK-positive (ALK+) advanced solid cancers, including non-small cell lung cancer