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

NCT04337931 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-02-13

Study results available
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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.

Conditions

Interventions

DRUG

sotigalimab

Sotigalimab is a CD40 agonistic monoclonal antibody

Sponsors & Collaborators

  • Apexigen America, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-12
Primary Completion
2022-07-29
Completion
2022-08-02
FDA Drug
Yes

Countries

  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04337931 on ClinicalTrials.gov