SNPMiner Trials by Shray Alag

SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT02642016

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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.

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.

NCT02642016 Advanced Cancer

1 Interventions

Name: CDX-0158 (formerly known as KTN-0158)

Description: Single agent CDX-0158 until unacceptable toxicity or progressive disease

Type: Biological


Primary Outcomes

Measure: Dose limiting toxicities for CDX-0158

Time: Participants will be evaluated for DLTs from the first adminstration of CDX-0158 through 21 days following initial dosing.

Purpose: Treatment

Single Group Assignment

There is one SNP


1 D842V

If documented to have SDH deficient or PDGFRA-D842V GIST, no prior therapy is required for study entry. --- D842V ---

HPO Nodes