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 therapy being studied in adults with gastrointestinal adenocarcinomas, a group of cancers affecting the digestive tract. It was evaluated in a Phase 1 clinical trial for safety and tolerability in this patient population. MEDI-565 is not approved for any indication and remains in clinical development.
MEDI-565 targets CD3E and CEACAM5. It is a cross-linking agent that binds both targets, a mechanism designed to bring immune effector cells into proximity with CEACAM5-expressing tumor cells. This dual-targeting approach is being explored in gastrointestinal adenocarcinomas.
MEDI-565 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating MEDI-565 in gastrointestinal adenocarcinomas.
MEDI-565 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently listed as active in any ongoing trials. MEDI-565 is investigational and has not been approved by the FDA for any indication.
MEDI-565 has been studied in one completed Phase 1 trial, NCT01284231, titled "A Study to Evaluate the Safety and Tolerability of MEDI-565 in Adults With Gastrointestinal Adenocarcinomas." The trial enrolled 78 participants in the United States and has been completed.