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Trial record 1 of 1 for:    cdx014-01
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A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Advanced or Metastatic Renal Cell Carcinoma

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Celldex Therapeutics
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics
ClinicalTrials.gov Identifier:
NCT02837991
First received: July 13, 2016
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).

Condition Intervention Phase
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 Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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)

Resource links provided by NLM:


Further study details as provided by Celldex Therapeutics:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 47
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)
Arms Assigned Interventions
Experimental: CDX-014

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.

Drug: CDX-014

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of advanced or metastatic clear cell or papillary renal cell carcinoma.
  2. At least two prior anticancer regimens (one must be a VEGF-targeted TKI), or are otherwise inappropriate candidates for all approved therapies.
  3. Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
  4. Measureable (target) disease.
  5. Must have available tumor tissue for TIM-1 expression testing
  6. Life expectancy ≥ 3 months
  7. If of childbearing potential (male or female), agrees to use effective contraception during study treatment and for at least 6 months following last treatment dose.

Exclusion Criteria:

  1. Prior therapy containing MMAE
  2. Prior cytotoxic chemotherapy regimen, including antibody drug conjugates
  3. TKI inhibitor therapy within 2 weeks or at least 5 half-lives (whichever is longer) prior to planned start of study treatment.
  4. Monoclonal antibody therapy within 4 weeks prior to the planned start of study treatment.
  5. Radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed up to 2 weeks prior to study treatment start).
  6. Major surgery or significant traumatic injury within 4 weeks prior to study entry.
  7. Use of other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study treatment.
  8. Concurrent severe and/or uncontrolled medical conditions (uncontrolled diabetes or infection), known infection with HIV, Hepatitis B or Hepatitis C.
  9. Brain metastases, unless previously treated and asymptomatic and not progressive for 2 months.
  10. Significant cardiovascular disease (including congestive heart failure).
  11. Other malignancy except for treated and cured basal or squamous cell skin cancer, cured in situ cancers, or other cancer from which the patient has been disease-free for ≥ 3 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02837991

Contacts
Contact: Celldex Therapeutics info@celldex.com

Locations
United States, Arizona
Pinnacle Oncology Hematology Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Michael S. Gordon, MD    480-860-5000    mgordon@azpoh.com   
Contact: John Whitaker    480-860-5000    jwhitaker@azpoh.com   
Principal Investigator: Michael S. Gordon, MD         
United States, California
USC/Norris Comprehensive Cancer Center Not yet 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    taison.tran@med.usc.edu   
Principal Investigator: David Quinn, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Deanna Hart    617-582-7334    deannam_hart@dfci.harvard.edu   
Contact: Alex J Pimental    617-582-9397    alexanderj_pimentel@dfci.harvard.edu   
Principal Investigator: Tony Choueiri, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Diane Poslinski    716-845-7754    diane.poslinski@roswellpark.org   
Contact: ASK RPCI    877-272-7724      
Principal Investigator: Saby George, MD         
United States, Ohio
Cleveland Clinic Foundation Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Laura Wood, RN, MSN OCN    216-444-9822    woodl@ccf.org   
Contact: Nathan Reynolds, MPH    216-636-5654    Reynoln2@ccf.org   
Principal Investigator: Brian Rini, MD         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Aferdit Sadrija    801-587-4771    aferdit.sadrija@hci.utah.edu   
Contact: Sally Fairbairn    801-587-4765    sally.fairbairn@hci.utah.edu   
Principal Investigator: Neeraj Agarwal, MD         
Sponsors and Collaborators
Celldex Therapeutics
  More Information

Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT02837991     History of Changes
Other Study ID Numbers: CDX014-01
Study First Received: July 13, 2016
Last Updated: January 24, 2017

Keywords provided by Celldex Therapeutics:
Kidney Cancer
Celldex
Dose Escalation

Additional relevant MeSH terms:
Carcinoma
Kidney Diseases
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Diseases
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on June 23, 2017