Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AVM0703 · 2 trials · 4 indications
The primary endpoint of the Phase 1 portion of the study is to evaluate the safety of AVM0703 in subjects with severe or life-threatening COVID-19 infection, and to identify the RP2D.
The primary endpoint of the Phase 1/2 portion of the study is to evaluate the efficacy of AVM0703 in subjects with severe or life-threatening COVID-19 infection.
The primary endpoint for the Phase 1 portion of the study is the incidence of Adverse events (AEs), including DLTs.
| Arm | Type | Description |
|---|---|---|
| AVM0703 COVID-19 ARDS - active | ACTIVE_COMPARATOR | Supra-pharmacologic dexamethasone sodium phosphate |
| Placebo COVID-19 ARDS - placebo | PLACEBO_COMPARATOR | Matching placebo |
| AVM0703 Influenza ARDS - active | ACTIVE_COMPARATOR | Supra-pharmacologic dexamethasone sodium phosphate |
| AVM0703 Influenza ARDS - placebo | PLACEBO_COMPARATOR | Matching placebo |
| DLBCL and high-grade B-cell lymphoma | EXPERIMENTAL | Diffuse Large Cell B-Lymphoma High-grade B-cell Lymphoma |
| MCL (Chronic Lymphoid Leukemia) | EXPERIMENTAL | Chronic Lymphoid Leukemia |
| Primary Mediastinal Large B-cell lymphoma | EXPERIMENTAL | Primary mediastinal large B-cell lymphoma |
| Burkitt or Burkitt-like lymphoma/leukemia | EXPERIMENTAL | Burkitt or Burkitt-like lymphoma/leukemia |
| CLL/SLL | EXPERIMENTAL | Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma |
| B- or T-ALL | EXPERIMENTAL | B-lymphoblastic leukemia/lymphoma, T-lymphoblastic leukemia/lymphoma, acute leukemia/lymphoma, acute leukemias of ambiguous lineage, or natural killer (NK) cell lymphoblastic leukemia/lymphoma |
| Name | Type | Description |
|---|---|---|
| AVM0703 | DRUG | Single IV infusion at 10 mg/mL in normal saline over 1 hour to patients. |
| Placebo | DRUG | Single IV infusion in normal saline over 1 hour to patients. |
Inclusion Criteria Patients who meet all of the following criteria will be eligible to participate in the study: 1. Age ≥18 years; 2. Must have laboratory confirmed COVID-19; 3. Must have moderate or severe, immediately life-threatening COVID-19 or Influenza (A or B), as follows: a. COVID-19 p...