drugset / Trial / NCT04333914
Prospective Study in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 Infection
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avdoralimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | GNS651 | Unknown | 200 mg | Oral |
| Subject | Monalizumab | Monoclonal antibody | 50 mg | Intravenous |