A Study to Evaluate APX005M in Subjects With Unresectable or Metastatic Melanoma

• Status: Recruiting
• Trial end date: 2022-11-12
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of APX005M administered at 2 different schedules to adult subjects with unresectable or metastatic melanoma. Subjects who have not received prior immunotherapy will be alternately assigned to 1 of 2 cohorts (2 different APX005M administration schedules) as long as both are open. Subjects who have failed approved immunotherapy regimens will be assigned to a 3rd cohort of APX005M in combination with radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apexigen, Inc.

Criteria

Inclusion

• Histologically or cytologically confirmed unresectable or metastatic melanom

• Measurable disease by RECIST 1.1

• Subjects with BRAF activating mutation must have received a BRAF inhibitor and/or MEK inhibitor regimen prior to study entry

Exclusion

• Use of systemic corticosteroids or other systemic immunosuppressive drugs within the 28 days prior to first dose of investigational product (except inhaled corticosteroids) History of allogeneic bone marrow transplantation

• Active, known or suspected autoimmune disease

• Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)

• History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis

• History of interstitial lung disease