drugset / Trial / NCT05232409

Determine Safety & Recommended Phase 2 Dosing of Zeaxanthin Alone or in Combination w/Pembrolizumab in Patients With Metastatic Cancer

NCT05232409

Phase 1 Recruiting 72 enrolled Valley Health System
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the research is to determine the highest dose of an oral compound called zeaxanthin that can be safely taken each day in patients with advanced cancer, the toxicity profile of zeaxanthin, and the dose of zeaxanthin to use in future cancer clinical trials.

Timeline

Start
2022-04-17
Primary completion
2028-03
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Zeaxanthin Small molecule 2 mg/kg Oral
Subject Zeaxanthin Small molecule 4 mg/kg Oral
Subject Zeaxanthin Small molecule 6 mg/kg Oral
Subject Zeaxanthin Small molecule 8 mg/kg Oral
Background Pembrolizumab Monoclonal antibody 400 mg Intravenous