A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
Summary
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.
Arms & interventions
- DrugTJ033721 (givastomig)
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
- DrugTJ033721 (givastomig) , nivolumab, chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy
- DrugTJ033721 (givastomig), chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), chemotherapy
- DrugTJ033721 (givastomig), durvalumab, chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), durvalumab, chemotherapy
Outcome measures
Primary
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
Secondary
Pharmacokinetic (PK) Parameters: AUC∞
Time frame: Up to 100 days post last dose
Pharmacokinetic (PK) Parameters: AUCt
Time frame: up to 100 days post last dose
Pharmacokinetic (PK) Parameters: Cmax
Time frame: up to 100 days post last dose
Pharmacokinetic Parameters: Tmax
Time frame: up to 100 days post last dose
Pharmacokinetic Parameters: T1/2
Time frame: up to 100 days post last dose
Eligibility criteria
Study locations (11)
Stern Center for Cancer Clinical Trials and Research
Orange, California, 92868
UCHealth Cancer Care - Anschutz Medical Campus
Aurora, Colorado, 80045
Horizon Oncology Research, LLC.
Layfayette, Indiana, 47905
Mass General Hospital
Boston, Massachusetts, 02114
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
NYU Langone
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Mary Crowley Cancer Research
Dallas, Texas, 75230
UW Carbone Cancer Center
Madison, Wisconsin, 53705