drugset / Trial / NCT04333914

Prospective Study in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 Infection

NCT04333914

Phase 2 Completed 19 enrolled Centre Leon Berard
RandomizedParallel-groupOpen-labelTreatment

Summary

A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit. According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts: * COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1). * COHORT 2 (moderate/severe symptoms): anti-C5aR vs standard of care (randomization ratio 1:1).

Timeline

Start
2020-04-15
Primary completion
2021-07-06
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Avdoralimab Monoclonal antibody 200 mg Intravenous
Subject GNS651 Unknown 200 mg Oral
Subject Monalizumab Monoclonal antibody 50 mg Intravenous

Indications