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Clinical trial of the CD40 agonist antibody APX005M in adults with unresectable or metastatic melanoma

THIS CLINICAL TRIAL AIMS TO DETERMINE THE CLINICAL BENEFIT IN TERMS OF DISEASE RESPONSE TO THE CLINICAL TRIAL DRUG IN PATIENTS WITH INOPERABLE OR METASTATIC MELANOMA. THE CLINICAL TRIAL WILL ALSO LOOK AT WHETHER THE CLINICAL TRIAL DRUG ACHIEVES A SURVIVAL BENEFIT, ITS SAFETY AND SOME BIOMARKERS OF RESPONSE IN THE BLOOD. A BIOMARKER IS A SUBSTANCE THAT MAY BE PRESENT IN THE BLOOD AND MAY BE RELATED TO RESPONSE OR RESISTANCE TO TREATMENT. THIS CLINICAL TRIAL EVALUATES WHETHER APX005M IS SAFE AND EFFECTIVE FOR THE TREATMENT OF 2 DIFFERENT GROUPS OF MELANOMA PATIENTS: -IN COHORTS 1 AND 2, TWO DIFFERENT ADMINISTRATION SCHEDULES OF APX005M (EVERY 3 WEEKS OR EVERY 2 WEEKS) ARE EVALUATED WHEN ADMINISTERED ALONE IN MELANOMA PATIENTS WHO HAVE NOT RECEIVED PRIOR IMMUNOTHERAPY. -COHORT 3 EVALUATES THE COMBINATION OF APX005M WITH LOCAL RADIOTHERAPY ADMINISTERED TO A SINGLE LESION IN MELANOMA PATIENTS FOR WHOM IMMUNOTHERAPY IS NO LONGER BENEFICIAL. WHEN COMBINED WITH APX005M, LOCAL RADIATION COULD PROVIDE A CRITICAL STIMULUS TO RENEW OR BOOST THE ANTITUMOR IMMUNE RESPONSE. FOR COHORT 3, RADIATION THERAPY IS CONSIDERED AN ADDITIONAL FORM OF STUDY TREATMENT.

Status
In recruitment
headquarters
Pamplona

Technical Summary

  • PHASE II, MULTICENTER, OPEN-LABEL, PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE CD40 AGONIST ANTIBODY APX005M WITH OR WITHOUT STEREOTACTIC BODY RADIOTHERAPY IN ADULTS WITH UNRESECTABLE OR METASTATIC MELANOMA.
  • Code EudraCT: 2018-003864-30
  • Protocol number: APX005M-010
  • Promoter: Apexigen, Inc.
  • Link to Clinical Trials

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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