A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and… (NCT02837991) | Clinical Trial Compass
TerminatedPhase 1
A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and Ovarian Clear Cell Carcinoma
Stopped: Development of CDX-014 discontinued
United States16 participantsStarted 2016-06
Plain-language summary
This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Dose Escalation - Determine Maximum Tolerated Dose (MTD)
✕. 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.