A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and Ovarian Clear Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02837991|
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma (RCC) Clear-cell Renal Cell Carcinoma Papillary Renal Cell Carcinoma Kidney Neoplasms Metastatic Renal Cell Carcinoma Ovarian Clear Cell Carcinoma||Drug: CDX-014||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase l Open-Label, Dose Escalation and Cohort Expansion Study, to Assess the Safety and Activity of the Antibody-Drug Conjugate CDX-014 in Advanced or Metastatic Renal Cell Carcinoma (RCC) and Advanced or Metastatic Ovarian Clear Cell Carcinoma (OCCC)|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||August 2020|
During the treatment phase of the study, patients will receive CDX-014 treatment every 3 weeks (RCC or OCCC) or every 2 weeks (RCC) 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.
The planned dose of CDX-014 depends on the cohort assigned at enrollment.
- Dose Escalation - Determine Maximum Tolerated Dose (MTD) [ Time Frame: Within 21 days after first dose. ]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.
- Cohort Expansion - 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837991
|Contact: Celldex Therapeuticsemail@example.com|
|United States, Arizona|
|HonorHealth Research Institute||Recruiting|
|Scottsdale, Arizona, United States, 85258|
|Contact: Michael S. Gordon, MD 623-238-7630 Michael.Gordon@honorhealth.com|
|Contact: John Whitaker 623-238-7630 John.Whitaker@honorhealth.com|
|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 firstname.lastname@example.org|
|Principal Investigator: David Quinn, MD|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Deanna Hart 617-582-7334 email@example.com|
|Contact: Alex J Pimental 617-582-9397 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Sally Fairbairn 801-587-4765 email@example.com|
|Principal Investigator: Neeraj Agarwal, MD|