drugset / Trial / NCT04495257

A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC)

NCT04495257

Phase 1 Completed 26 enrolled Yale University Apexigen America, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is a Phase 1, open-label, single institution, dose escalation and dose expansion study to evaluate the efficacy, safety, and tolerability of APX005M in combination with nivolumab and ipilimumab in patients with advanced melanoma and RCC.

Timeline

Start
2020-09-14
Primary completion
2026-03-04
Completion
2026-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 360 mg Intravenous
Subject sotigalimab Monoclonal antibody 0.1 mg/kg Intravenous
Subject sotigalimab Monoclonal antibody 0.3 mg/kg Intravenous