A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or

Status Terminated

Clinical Trial 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 sotigalimab (APX005M) administered at 2 different schedules to adult participants with unresectable or metastatic melanoma. Participants who have not received prior immunotherapy will be alternately assigned to 1 of 2 cohorts with different sotigalimab administration schedules as long as both are open for enrollment. Participants who have failed any number of prior lines of therapy will be assigned to a 3rd cohort of sotigalimab in combination with radiation therapy.

Clinical Trial Description

This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of Sotigalimab administered at 2 different schedules to adult participants with unresectable or metastatic melanoma who have not received prior immunotherapy. Enrolled participants will be alternately assigned to one of the following 2 cohorts (groups) as long as both cohorts are open. Cohort 1: APX005M administered IV at 0.3 mg/kg every 3 weeks (21-day cycle) Cohort 2: APX005M administered IV at 0.3 mg/kg every 2 weeks (14-day cycle) Sotigalimab in combination with stereotactic body radiation therapy (SBRT) in adults with unresectable or metastatic melanoma who have failed any number of prior lines of therapy will be assigned to Cohort 3: Sotigalimab administered IV at 0.3 mg/kg in combination with radiation therapy every 2 weeks (14 day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle). Primary Objective • Evaluate the overall response rate (ORR) by RECIST 1.1 measurements in each of the cohorts. Secondary Objectives - Evaluate the safety of sotigalimab alone or in combination with radiation therapy in each cohort - Evaluate ORR by modified RECIST 1.1 for immune-based therapeutics (iRECIST) in each cohort - Evaluate median duration of response (DOR) in each cohort ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04337931
Study type	Interventional
Source	Apexigen America, Inc.
Contact
Status	Terminated
Phase	Phase 2
Start date	June 12, 2019
Completion date	August 2, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms