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)
Condition: 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
Purpose: This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT02837991
Sponsor: Celldex Therapeutics
Primary Outcome Measures:
- Measure: Dose Escalation - Determine Maximum Tolerated Dose (MTD)
- Time Frame: Within 21 days after first dose.
- Safety Issue:
- Measure: 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.
- Safety Issue:
Estimated Enrollment: 125
Study Start Date: June 2016
Phase: Phase 1
- Age: minimum 18 Years maximum N/A
- Gender: All
- Histologically confirmed diagnosis of advanced or metastatic clear cell or papillary renal cell carcinoma or histologically confirmed clear cell ovarian carcinoma.
- 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.
- Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
- Measureable (target) disease.
- Must have available tumor tissue for TIM-1 expression testing
- Life expectancy ≥ 3 months
- 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.
- Prior therapy containing MMAE
- Any prior cytotoxic chemotherapy regimen, including antibody drug conjugates for RCC or cytotoxic chemotherapy within 3 weeks of study treatment for OCCC
- Tyrosine kinase inhibitor (TKI) therapy within 2 weeks or at least 5 half-lives (whichever is longer) prior to planned start of study treatment.
- Monoclonal antibody therapy within 4 weeks prior to the planned start of study treatment.
- 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).
- Major surgery or significant traumatic injury within 4 weeks prior to study entry.
- Use of other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study treatment.
- Concurrent severe and/or uncontrolled medical conditions (uncontrolled diabetes or infection), known infection with HIV, Hepatitis B or Hepatitis C.
- Brain metastases, unless previously treated and asymptomatic and not progressive for 2 months.
- Significant cardiovascular disease (including congestive heart failure).
- 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.
- Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
- 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
- Celldex Therapeutics
- HonorHealth Research Institute
- Scottsdale Arizona 85258 United States
- USC/Norris Comprehensive Cancer Center
- Los Angeles California 90033 United States
- Dana Farber Cancer Institute
- Boston Massachusetts 02215 United States
- Roswell Park Cancer Institute
- Buffalo New York 14263 United States
- Huntsman Cancer Institute
- Salt Lake City Utah 84112 United States
View trial on ClinicalTrials.gov