An open label, dose escalation and dose expansion study to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
A phase 1, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy. The primary objective of this study is to determine the MTD or RP2D of STP707 and to establish the dose of STP707 recommended for future phase 2 studies administered intravenously. A total of 30 subjects will be enrolled in dose escalation. Once MTD or RP2D has been established, up to 10 additional subjects will enrolled to confirm safety and explore anti-tumor activity. Up to 5 dose levels will be explored (3,6,12,24,48 mg dose levels). Intermediate doses between scheduled dose levels maybe explored during escalation. A cycle is 28 days. Dose escalation will follow a standard 3+3 design.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
STP707 Powder for Injection
Mayo Clinic
Phoenix, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
Maximum Tolerated Dose (MTD)
Recommended starting dose \& schedule
Time frame: 28 Day Cycle
Limited Dose Toxicity (LDT)
Recommended starting dose \& dose escalation
Time frame: 28 day cycle
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