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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04049903 | Study to Investigate the Safety, Blood Levels and Activity of MP0310 in Patients With Advanced Solid Tumors | PHASE1 | COMPLETED | 38 | — | — | Sep 2, 2019 | Dec 21, 2022 | Dec 22, 2022 | 3 | France |
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Dose-limiting toxicities will be reviewed as a subset of AEs that occur within the first 21 days of dosing and meet the protocol-specified criteria.
Based on occurrence of DLTs within a 3+3 clinical trial design
Based on incidence and nature of DLTs, and incidence, nature, and severity of AEs and serious adverse events (SAEs)
| Arm | Type | Description |
|---|---|---|
| MP0310 Part A | EXPERIMENTAL | Enrollment will follow a standard 3 + 3 dose escalation design. Sequential Cohorts of patients will be dosed until the MTD or unacceptable toxicity is reached. Up to 12 additional patients in total may be included at selected dose levels (up to 3). |
| MP0310 Part B | EXPERIMENTAL | weekly schedule, at least 3 and up to 24 patients evaluable for DLT assessment will be enrolled (1 to 4 cohorts with 3 to 6 patients each (3 initial plus up to 3 backfill patients)). |
| MP0310 Part C | EXPERIMENTAL | q3w schedule implementing B-cell depletion, at least 3 and up to 12 patients evaluable for DLT assessment will be enrolled (1 to 2 cohorts with 3 to 6 patients each (3 initial plus up to 3 backfill patients)). |
| Name | Type | Description |
|---|---|---|
| MP0310 | DRUG | MP0310 will be examined for safety, tolerability, PK, and PD activity in subjects with advanced solid tumors |
Inclusion criteria: 1. Patient has an advanced, histologically-proven solid tumor of one of the following types, treated with at least one line of systemic therapy, and for which approved therapies have been exhausted or for which the Investigator considers the patient ineligible or intolerant of o...
| 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 |