This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy
Stern Center for Cancer Clinical Trials and Research
Orange, California, United States
Dose-limiting toxicities (DLTs)
Time frame: 28 days
Incidence and severity of AEs
The CTCAE criteria will be used to assess adverse events on this trial.
Time frame: Up to 100 days post last dose
Maximum tolerated or administered dose (MTD, MAD)
Based on DLT definitions
Time frame: 28 Days
Pharmacokinetic (PK) Parameters: AUC∞
Area under the curve from time zero extrapolated to infinity (AUC∞)
Time frame: Up to 100 days post last dose
Pharmacokinetic (PK) Parameters: AUCt
AUC from time zero to the time of the last quantifiable concentration (AUC0-t)
Time frame: up to 100 days post last dose
Pharmacokinetic (PK) Parameters: Cmax
Maximum observed concentration
Time frame: up to 100 days post last dose
Pharmacokinetic Parameters: Tmax
Time of peak concentration (Tmax)
Time frame: up to 100 days post last dose
Pharmacokinetic Parameters: T1/2
Investigational Product (IP) half-life (T1/2)
Time frame: up to 100 days post last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UCHealth Cancer Care - Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGHorizon Oncology Research, LLC.
Layfayette, Indiana, United States
COMPLETEDMass General Hospital
Boston, Massachusetts, United States
RECRUITINGRutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
ACTIVE_NOT_RECRUITINGNYU Langone
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGCarolina BioOncology Institute
Huntersville, North Carolina, United States
COMPLETEDVanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
RECRUITINGMary Crowley Cancer Research
Dallas, Texas, United States
COMPLETED...and 11 more locations