Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MP0310 · 1 trial · 1 indication
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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
MP0310 is an investigational small molecule developed by Molecular Partners AG for the treatment of advanced solid tumors. It is designed to act on the 4-1BB costimulatory receptor and has been studied in a Phase 1 clinical trial. It is not an approved therapy and remains in clinical development.
MP0310 targets 4-1BB, a costimulatory receptor. By engaging this receptor, the drug is designed to support immune cell activation in the tumor setting. The 4-1BB target class is a costimulatory receptor, which distinguishes it from checkpoint inhibitors that block inhibitory signals.
MP0310 is being developed by Molecular Partners AG, a biopharmaceutical company whose shares trade under the ticker MOLN. The company sponsored the Phase 1 study of the compound in patients with advanced solid tumors.
MP0310 is in Phase 1 development. The single clinical trial of the compound, NCT04049903, has been completed. The study enrolled 38 patients with advanced solid tumors and was conducted in France. MP0310 is investigational and has not been approved for any indication.
MP0310 has been evaluated in one clinical trial, NCT04049903, titled a study to investigate the safety, blood levels and activity of MP0310 in patients with advanced solid tumors. That Phase 1 trial is completed, enrolled 38 participants, and was conducted in France in adults aged 18 years and older.
MP0310 was studied in patients with advanced solid tumors in a Phase 1 trial. The study assessed safety, blood levels and activity of the compound in that population. Because the trial is complete and the drug is investigational, MP0310 is not an approved treatment for advanced solid tumors or any other condition.