Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SIBP-A13 formulation · 1 trial · 1 indication
That is adverse events, any adverse events that occurred to the participant during the study period.
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
It shows the degree to which a drug is absorbed and used in the body.
It shows the highest plasma concentration of a drug that can be achieved after administration.
That is peak time of drug action, it shows the time required to reach the maximum concentration on the participant plasma concentration curve after administration.
It reflects how quickly the drug is eliminated from the body.
Apparent volume of drug distribution removed from the body per unit time.
| Arm | Type | Description |
|---|---|---|
| SIBP-A13 | EXPERIMENTAL | SIBP-A13: injection; strength: 1, 2, 4, 5, 6 or 8 mg; dose escalation and the first group is 1mg (intravenous infusion). |
| Name | Type | Description |
|---|---|---|
| SIBP-A13 formulation for injection | DRUG | SIBP-A13: injection; strength: 1, 2, 4, 5, 6 or 8 mg; dose escalation and the first group is 1mg (intravenous infusion). Starting from the lowest dose, when the former does not meet the termination criteria, then start the next dose group study until Maximum Tolerated Dose (MTD). The study adopts a "3+3" dose increasing design. Administration period: divided into single administration and multiple administration. Single dose administration: The participants are administered a single dose on the first day for a total of 21 days of observation, and complete the examinations and evaluations specify in the protocol. If dose-limiting toxicity (DLT) does not occur, the participant enters a multiple dosing period. Multiple administration: administration every 3 weeks. |
Inclusion Criteria: * Age range from 18 to 75 years old (including boundary values), regardless of gender. * The clinical diagnosis of enrolled participants should meet the following criteria: 1. Dose escalation and dose expansion stage: Patients with locally advanced or metastatic solid tumors ...
| 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 |