Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI-565 · 1 trial · 1 indication
MTD/OBD will be determined based on Dose Limiting Toxicities that will be evaluated from the time of first administration of MEDI-565 through the first 28-day cycle
The number (percentage) of subjects with AEs and SAEs reported through 30 days after the last dose of MEDI 565 will be summarized for all subjects who received at least one dose of study drug (Safety Population).
| Arm | Type | Description |
|---|---|---|
| MEDI-565 - Dose Escalation | EXPERIMENTAL | Up to 15 dose-escalation cohorts will be enrolled |
| MEDI-565 Dose Expansion Arm 1 | EXPERIMENTAL | 20 subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biologic dose |
| MEDI-565 Dose Expansion Arm 2 | EXPERIMENTAL | 20 subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biologic dose |
| MEDI-565 Dose Expansion Arm 3 | EXPERIMENTAL | Subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biological dose |
| Name | Type | Description |
|---|---|---|
| MEDI-565 | DRUG | MEDI-565 will be administered by IV infusion |
Inclusion Criteria: * Age ≥ 18 years of age at the time of screening * Adequate contraception from screening through end of trial * For the dose-escalation phase, subjects with GI adenocarcinomas with no available standard or curative treatments * Adequate hematological function * Adequate organ fu...
MEDI-565 is an investigational small molecule being studied for the treatment of gastrointestinal adenocarcinomas. It is currently in Phase 1 clinical development, meaning it has not been approved by regulatory authorities. The drug is being evaluated for its safety and tolerability in adult patients with this type of cancer.
MEDI-565 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research to evaluate the drug's potential in treating gastrointestinal adenocarcinomas, though the drug remains in the investigational stage.
MEDI-565 is in Phase 1 clinical development. This means it is in the early stages of testing in humans, primarily to assess safety and tolerability. The drug is investigational and has not received approval from regulatory agencies for commercial use in any indication.
MEDI-565 has been studied in one clinical trial with the identifier NCT01284231. This Phase 1 study, titled 'A Study to Evaluate the Safety and Tolerability of MEDI-565 in Adults With Gastrointestinal Adenocarcinomas,' has been completed. The trial enrolled 78 participants in the United States and included adults aged 18 years and older.
MEDI-565 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for gastrointestinal adenocarcinomas. The completed clinical trial, NCT01284231, was designed to evaluate safety and tolerability, but the drug has not yet progressed through the later phases required for regulatory approval.