This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Escalating Doses
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Houston, Texas, United States
Determine the MTD
Time frame: 28 days
Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings
Time frame: 28 days
Area under the plasma concentration (AUC) Versus Time Curve of SM04755
Time frame: 30 days
Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 8 weeks
Maximum Observed Plasma Concentration (Cmax) of SM04755
Time frame: 30 Days
Half Life of SM04755
Time frame: 30 Days
Volume of Distribution of SM04755
Time frame: 30 Days
Time to maximum plasma concentration
Time frame: 30 Days
Accumulation ratio of SM04755
Time frame: 30 Days
Total Clearance of SM04755 after oral administration
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.