Clinical Trial: A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Advanced or Metastatic Renal Cell Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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)

Brief Summary: This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).

Detailed Summary:

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.


Sponsor: Celldex Therapeutics

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Celldex Therapeutics

Dates:
Date Received: July 13, 2016
Date Started: June 2016
Date Completion: August 2020
Last Updated: January 24, 2017
Last Verified: January 2017