Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MDNA11 · 1 trial · 37 indications
Evaluation of tolerability as measured by number of patients with dose limiting toxicities (DLTs)
Rate of TRAEs in patients with advanced solid tumors
Rate of TEAEs in patients with advanced solid tumors
| Arm | Type | Description |
|---|---|---|
| MDNA11 | EXPERIMENTAL | MDNA11 is a long-acting "beta-only" recombinant interleukin-2 (rIL-2) albumin fusion |
| Name | Type | Description |
|---|---|---|
| MDNA11 | DRUG | MDNA11 will be administered, IV on a once every 2 weeks (Q2W) dosing schedule. Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg): until determining the monotherapy Recommended Dose for Expansion (mRDE). |
| Pembrolizumab (KEYTRUDA®) | DRUG | MDNA11 will be administered in combination with pembrolizumab, IV. MDNA11 dose range to be evaluated in combination with pembrolizumab until determining the combination Recommended Dose for Expansion (cRDE). |
Key Inclusion Criteria: 1. Aged at least 18 years (inclusive at the time of informed consent). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. 3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must b...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |