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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05888857 | MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors. | PHASE2 | NOT YET_RECRUITING | 102 | — | — | Sep 1, 2025 | Sep 1, 2028 | Aug 13, 2025 | 1 | France |
Antitumor activity will be assessed in terms of objective response rate within 24 weeks based on RECIST v1.1, independently for each cohort, and based on centralized radiological review. Objective response under treatment is defined as patients with confirmed complete response or confirmed partial response, as per RECIST v1.1, observed during treatment with the investigational product. Objective response rate is defined as the proportion of patients alive with objective response based on RECIST v1.1. Objective response is recorded from study treatment initiation until the end of treatment.
| Arm | Type | Description |
|---|---|---|
| Cohort A: patients with TLS+ IO-naïve solid tumors | EXPERIMENTAL | Participants with TLS+ IO-naïve solid tumors will be treated by MEDI5752 |
| Cohort B: patients with TLS+ PD1/PDL1-experienced solid tumors | EXPERIMENTAL | Participants with TLS+ PD1/PDL1-experienced solid tumors will be treated by MEDI5752 |
| Name | Type | Description |
|---|---|---|
| MEDI5752 | DRUG | A treatment cycle consists of 3 weeks. MEDI5752 will be administered by intravenous infusion at a fixed dose on Day 1 of each cycle |
Inclusion Criteria: 1. Histologically confirmed solid tumor 2. IO-naïve patients (cohort A) OR patients with secondary resistance to PD1/PDL1 inhibitors (cohort B), 3. Patients in cohort B: 1. have to be diagnosed previously treated with PD-L1/PD-1 inhibitors (investigational or approved), 2...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |