A Phase I Dose Escalation Study of NKP-1339 Administered on Days 1, 8 and 15 of Each 28-Day Cycle in Patients With Advanced Solid Tumors Refractory to Treatment
NKP-1339 is a novel GRP78 targeted ruthenium based anti-cancer compound which is
intravenously administered. GRP78 is a key regulator of misfolded protein processing, which
is unregulated in cancer cells. In nonclinical anti-tumor studies, NKP-1339 showed activity
against many tumor types, including those resistant to platinum and other standard
anti-cancer agents. This Phase I trial evaluates the safety, tolerability, maximum tolerated
dose, pharmacokinetics, and pharmacodynamics of NKP-1339.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants with related adverse events
The incidence and severity of related adverse events and laboratory abnormalities will be used to assess the safety and tolerability of NKP-1339.
Daniel D. Von Hoff, MD
TGEN Clinical Research Services at Scottsdale Healthcare
United States: Food and Drug Administration
|The Sarah Cannon Research Institute||Nashville, Tennessee 37203|
|TGen Clinical Research Services at Scottsdale Healthcare||Scottsdale, Arizona 85258|