TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer, including: 1. Anaplastic lymphoma kinase (ALK) 2. The tropomyosin-related kinases TRKA, TRKB, and TRKC This is a sequential, open-label, non-randomized study with dose escalation in Phase 1, followed by expansion at a recommended phase 2 dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Number of cycles until progression or unacceptable toxicity develops.
Unnamed facility
Goodyear, Arizona, United States
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Los Angeles, California, United States
Incidence of Adverse Events (AEs)
Time frame: Approximately 2 years
Area Under the Concentration-Time Curve (AUC)
Time frame: Day 1: 0-24 hrs after first dose; pre-dose on days 8 & 15; day 29: 0-24 hours
Maximum Tolerated Dose (MTD)
Phase 1, during the dose-escalation phase
Time frame: 28 days after first dose
Response Rate (RR)
Phase 2
Time frame: approximately 2 years
Dose limiting toxicity (DLT)
Phase 1, during the dose escalation phase
Time frame: 28 days after first dose
Progression Free Survival (PFS)
Phase 2
Time frame: approximately 2 years
Recommended Phase 2 Dose (RP2D)
Phase 1
Time frame: approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Nashville, Tennessee, United States
Unnamed facility
Norfolk, Virginia, United States
Unnamed facility
Spokane, Washington, United States
Unnamed facility
Poznan, Greater Poland Voivodeship, Poland
Unnamed facility
Warsaw, Masovian Voivodeship, Poland
Unnamed facility
Gdansk, Pomeranian Voivodeship, Poland
Unnamed facility
Olsztyn, Warmian-Masurian Voivodeship, Poland
...and 5 more locations