Trials / Completed
CompletedNCT02642016
A Study to Evaluate the Safety and Pharmacokinetics of CDX-0158 in Adult Patients With Advanced Solid Tumors
A Phase 1, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CDX-0158 in Adult Patients With KIT Positive Advanced Solid Tumors.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Celldex Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose, and the safety profile of CDX-0158 in patients with KIT-positive advanced solid malignancies refractory to standard therapy or for which no standard therapy exists.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CDX-0158 (formerly known as KTN-0158) | Single agent CDX-0158 until unacceptable toxicity or progressive disease |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2018-01-30
- Completion
- 2019-06-04
- First posted
- 2015-12-30
- Last updated
- 2019-06-12
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02642016. Inclusion in this directory is not an endorsement.