HTI-1066 is a novel ADC being developed for the treatment of cancers in patients with overexpression of c-Met. This 2-part, Phase 1 study evaluates the safety the tolerability of HTI-1066 in subjects with advanced solid tumors.
This is a 2-part dose escalation and dose expansion study. Dose escalation uses a modified "3+3" design and continues until a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified. In part 2, subjects with selected tumor types will be enrolled at the MTD or RP2D.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Starting dose level
2nd dose level
3rd dose level
Honor Health Research Institute
Scottsdale, Arizona, United States
RECRUITINGSarah Cannon - Tennessee Oncology
Nashville, Tennessee, United States
NOT_YET_RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
NOT_YET_RECRUITINGAdverse events
Number of participants with AEs and SAEs
Time frame: Up to 2 year
Dose-limiting toxicity (DLT)
Number of participants with DLTs
Time frame: Up to 2 years
AUC
Area under the curve
Time frame: Up to 1 year
Cmax
Peak concentration at Tmax
Time frame: Up to 1 year
Anti-drug antibodies
Time frame: Up to 2 year
Objective response rate
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
4th dose level