A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Advanced or Metastatic Renal Cell Carcinoma
|Renal Cell Carcinoma Clear-cell Renal Cell Carcinoma Papillary Renal Cell Carcinoma Kidney Diseases Kidney Neoplasms Metastatic Renal Cell Carcinoma||Drug: CDX-014||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase l/ll Open-Label, Dose Escalation, Safety and Activity Study of the Antibody-Drug Conjugate CDX-014 in Advanced or Metastatic Renal Cell Carcinoma (RCC)|
- Phase l - Determine Maximum Tolerated Dose (MTD) [ Time Frame: Within 21 days after first dose. ]Determine the maximum tolerated dose (MTD) and 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.
- Phase ll - Assess Objective Response Rate (ORR) [ Time Frame: Evaluated every 6-9 weeks following treatment initiation until treatment is discontinued or disease progression, up to 5 years. ]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.
|Study Start Date:||June 2016|
|Estimated Study Completion Date:||August 2020|
|Estimated Primary Completion Date:||April 2019 (Final data collection date for primary outcome measure)|
During the treatment phase of the study, patients will receive CDX-014 treatment every 3 weeks as long as they remain eligible. Patients may be discontinued from CDX-014 treatment based on the results of disease assessments or if experiencing side effects that make study therapy intolerable.
Phase I Dose: The planned dose of CDX-014 depends on the cohort assigned at enrollment.
Phase II Dose: The recommended CDX-014 dose will be established from the outcome of the Phase I portion of the study.
CDX-014 is an antibody-drug conjugate that binds to a protein called TIM-1, which is found on a high percentage of kidney cancer cells and other tumors.
The study will enroll patients with advanced or metastatic renal cell carcinoma to determine the safety and efficacy of CDX-014.
Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several levels of CDX-014. The first phase of the study will test the safety profile of CDX-014 and determine which dose of CDX-014 will be studied in the Phase II portion of the study.
During Phase II, up to 25 patients will be enrolled and receive the recommended Phase II dose of CDX-014.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02837991
|Contact: Celldex Therapeuticsfirstname.lastname@example.org|
|United States, Arizona|
|HonorHealth Research Institute||Recruiting|
|Scottsdale, Arizona, United States, 85258|
|Contact: Michael S. Gordon, MD 480-860-5000 email@example.com|
|Contact: John Whitaker 480-860-5000 firstname.lastname@example.org|
|Principal Investigator: Michael S. Gordon, MD|
|United States, California|
|USC/Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Cheryl Kefauver, RN, CCRP 323-865-0845 Cheryl.Kefauver@med.usc.edu|
|Contact: Taison Tran, CCRP 323-226-2397 email@example.com|
|Principal Investigator: David Quinn, MD|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Deanna Hart 617-582-7334 firstname.lastname@example.org|
|Contact: Alex J Pimental 617-582-9397 email@example.com|
|Principal Investigator: Bradley McGregor, MD|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Diane Poslinski 716-845-7754 firstname.lastname@example.org|
|Contact: ASK RPCI 877-272-7724|
|Principal Investigator: Saby George, MD|
|United States, Utah|
|Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Aferdit Sadrija 801-587-4771 email@example.com|
|Contact: Sally Fairbairn 801-587-4765 firstname.lastname@example.org|
|Principal Investigator: Neeraj Agarwal, MD|