Trials / Terminated
TerminatedNCT02837991
A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and Ovarian Clear Cell Carcinoma
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)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Celldex Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).
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.
Conditions
- Renal Cell Carcinoma (RCC)
- Clear-cell Renal Cell Carcinoma
- Papillary Renal Cell Carcinoma
- Kidney Neoplasms
- Metastatic Renal Cell Carcinoma
- Ovarian Clear Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CDX-014 |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2018-11-16
- Completion
- 2018-11-16
- First posted
- 2016-07-20
- Last updated
- 2020-06-04
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02837991. Inclusion in this directory is not an endorsement.