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.
Interventional
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.
8 weeks
Yes
Daniel D. Von Hoff, MD
Principal Investigator
TGEN Clinical Research Services at Scottsdale Healthcare
United States: Food and Drug Administration
NKP-1339-09-002
NCT01415297
September 2009
May 2013
Name | Location |
---|---|
The Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
TGen Clinical Research Services at Scottsdale Healthcare | Scottsdale, Arizona 85258 |