Condition: Locally Advanced Solid Tumor · Metastatic Solid Tumor · Sponsor: Nuvalent Inc.
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 activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors. A drug-drug interaction (DDI) sub-study will determine the effect of neladalkib on the pharmacokinetics of midazolam and repaglinide, as well as the effect of itraconazole on the pharmacokinetics of neladalkib, in patients with advanced ALK-positive NSCLC
This description comes directly from the study's public registry record.
Nuvalent Clinical Trial · 857-357-7000 · clinicaltrials@nuvalent.com
Always discuss trial participation with your own doctor first.
| University of California Irvine Medical Center | Orange, California, United States | Recruiting |
| University of California, Davis Comprehensive Cancer Center | Sacramento, California, United States | Recruiting |
| Stanford Cancer Institute | Stanford, California, United States | Recruiting |
| University of Colorado Cancer Center | Aurora, Colorado, United States | Recruiting |
| Georgetown University Medical Center | Washington D.C., District of Columbia, United States | Recruiting |
| University of Miami; Sylvester Cancer Center | Miami, Florida, United States | Recruiting |
| Winship Cancer Institute, Emory University | Atlanta, Georgia, United States | Recruiting |
| University of Chicago Medical Center | Chicago, Illinois, United States | Recruiting |
| John Hopkins University | Baltimore, Maryland, United States | Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| Dana Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
| Henry Ford Cancer Institute | Detroit, Michigan, United States | Recruiting |
+ 62 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05384626