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Clinical trial of GDC-1971 in combination with atezolizumab in patients with locally advanced or metastatic solid tumors.

THE OBJECTIVE OF THIS STUDY (CLINICAL TRIAL) IS TO EVALUATE GDC-1971 AT DIFFERENT DOSES, WHEN ADMINISTERED IN COMBINATION WITH ATEZOLIZUMAB, TO DETERMINE WHETHER GDC-1971 IS SAFE IN COMBINATION WITH ATEZOLIZUMAB AND TO LEARN HOW IT IS PROCESSED BY THE BODY. THE STUDY CONSISTS OF TWO PARTS: A DOSE-FINDING STAGE AND A SCALE-UP STAGE. ATEZOLIZUMAB IS AN ANTIBODY (A PROTEIN SIMILAR TO THOSE PRODUCED BY THE BODY'S IMMUNE SYSTEM) THAT BLOCKS THE PROGRAMMED CELL DEATH LIGAND 1 (PD-L1) PATHWAY. THE PD-L1 PATHWAY IS INVOLVED IN REGULATING THE BODY'S NATURAL IMMUNE RESPONSE, BUT TUMORS CAN TAKE ADVANTAGE OF THIS REGULATION TO PARTIALLY RESIST OR EVADE THE IMMUNE SYSTEM. BY BLOCKING THE PD-L1 PATHWAY, ATEZOLIZUMAB COULD HELP THE IMMUNE SYSTEM STOP OR REVERSE TUMOR GROWTH. GDC-1971 AND ATEZOLIZUMAB BLOCK CANCER CELL GROWTH IN DIFFERENT WAYS AND THE COMBINATION OF THE TWO DRUGS COULD HELP ATEZOLIZUMAB'S EFFECT ON THE PD-L1 PATHWAY. IN THIS STUDY, GDC-1971 AND ATEZOLIZUMAB WILL BE ADMINISTERED IN COMBINATION FOR THE FIRST TIME. THIS IS AN OPEN-LABEL STUDY, WHICH MEANS THAT BOTH THE PATIENT AND THE PHYSICIAN WILL KNOW THE DOSE OF THE STUDY DRUG AND THE STUDY TREATMENT ASSIGNED.

Status
In recruitment
headquarters
Pamplona

Technical Summary

  • PHASE IB OPEN-LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND ACTIVITY OF GDC-1971 IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS. IMMUNOTHERAPY
  • Code EudraCT: 2021-006479-40
  • Protocol number: GO43712
  • Promoter: Genentech, Inc.
  • Link to Clinical Trials

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