This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).
CDX-014 is an antibody-drug conjugate that binds to a protein called TIM-1, which is found on a high percentage of kidney cells that are clear or papillary and ovarian cancer cells that are clear cell. The study will enroll patients with advanced or metastatic renal cell carcinoma and ovarian clear cell carcinoma to determine the safety and efficacy of CDX-014. This study will include a Dose-Escalation Phase followed by a Cohort Expansion Phase All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
HonorHealth Research Institute
Scottsdale, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Dose Escalation - Determine Maximum Tolerated Dose (MTD)
Determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of CDX-014 (in mg/kg). MTD will be defined as the highest dose-level where DLT (dose-limiting toxicity) occurs in less than 33% of treated patients.
Time frame: Within 21 days after first dose.
Cohort Expansion - Assess Objective Response Rate (ORR)
Objective Response Rate (ORR) defined as the proportion of patients who achieve radiographic partial or complete response according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.
Time frame: Evaluated every 6-9 weeks following treatment initiation until treatment is discontinued or disease progression, up to 5 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Huntsman Cancer Institute
Salt Lake City, Utah, United States