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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 : Active, not recruiting
First Posted : July 20, 2016
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics

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

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

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 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)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : October 2018
Estimated Study Completion Date : October 2018


Arm Intervention/treatment
Experimental: CDX-014

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.

Drug: CDX-014



Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 or histologically confirmed clear cell ovarian carcinoma.
  2. For RCC, at least two prior anticancer regimens (one must be a VEGF-targeted TKI), or are otherwise inappropriate candidates for all approved therapies. For OCCC, at least one line of prior therapy with a platinum and taxane regimen.
  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. Any prior cytotoxic chemotherapy regimen, including antibody drug conjugates for RCC or cytotoxic chemotherapy within 3 weeks of study treatment for OCCC
  3. Tyrosine kinase inhibitor (TKI) 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.
  12. Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
  13. Chronic use of systemic corticosteroid above an accepted physiologic dose (5mg per day of prednisone or equivalent) within 7 days of enrollment except when used as premedication

Information from the National Library of Medicine

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


Locations
United States, Arizona
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Celldex Therapeutics

Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT02837991     History of Changes
Other Study ID Numbers: CDX014-01
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: January 2018

Keywords provided by Celldex Therapeutics:
Kidney Cancer
Celldex
Dose Escalation
Ovarian Cancer
Ovarian Carcinoma
Kidney Diseases

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