Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03811652 | A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors | PHASE1 | COMPLETED | 8 | — | — | Dec 20, 2018 | Dec 10, 2019 | Dec 30, 2019 | 3 | United States, Canada |
To assess the occurrence of adverse events
To assess the occurrence of serious adverse events
To assess the occurrence of toxicities and abnormal laboratory results that may limit further dose administration
To assess serum chemistry, hematology, urinalysis and coagulation parameters
to assess changes in vital signs
to assess changes in ECG
to assess changes in serum chemistry, hematology, urinalysis, and coagulation parameters
| Arm | Type | Description |
|---|---|---|
| NSCLC-Sq/HNSCC | EXPERIMENTAL | Patients with advanced or metastatic NSCLC-Sq or HNSCC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen (platinum-based for HNSCC). PDL-1 positive patients should have received previous PD-1 or PD-L1 inhibitor where available. |
| Small Cell Lung Cancer | EXPERIMENTAL | Patients with advanced SCLC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen. |
| Colorectal Cancer | EXPERIMENTAL | Patients with metastatic adenocarcinoma of the colon or rectum who have received and have progressed, or have documented intolerance, on prior thymidylate synthase inhibitor (eg, 5-fluorouracil (5-FU), capecitabine, raltitrexed, tegafur-uracil (UFT), irinotecan, and oxaliplatin for metastatic disease. If patients progress within 6 months of their last dose of adjuvant therapy this should be considered as a line of therapy in the metastatic setting. Patients with known RAS wildtype tumors must have received and progressed, or have documented intolerance, on anti-EGFR antibody. Patients with microsatellite instability-high or deficient mismatch repair tumors, must have received and progressed, or have documented intolerance on a PD-1 inhibitor, or PD-1 inhibitor plus cytotoxic T-lymphocyte antigen-4 inhibitor treatment where available. |
| Pancreatic Ductal Adenocarcinoma | EXPERIMENTAL | Patients with unresectable, locally advanced or metastatic PDAC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior line of treatment. |
| Metastatic Castration-Resistant Prostate Cancer | EXPERIMENTAL | Patients with mCRPC who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting. |
| Other advanced/metastatic target expressing solid tumors | EXPERIMENTAL | Patients with advanced or metastatic solid tumors not defined by other treatment arms who have positive expression of the protein target and have exhausted all approved therapies |
| Name | Type | Description |
|---|---|---|
| MEDI7247 | DRUG | Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule |
Inclusion Criteria: 1. Confirmed diagnosis of advanced or metastatic select solid tumors and either progression on or documented intolerance to standard therapies 2. Age ≥ 18 years at the time of screening. 3. Written informed consent and any locally required authorization 4. Eastern Cooperative On...