Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MDX2001 · 1 trial · 21 indications
Incidence and severity of AEs and serious AEs (SAEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 including changes in clinical laboratory parameters
Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Recommended Phase 2 dose is determined following the evaluation of MDX2001 safety including the incidences of dose limiting toxicities (DLTs), MDX2001 anti-tumor activity, and MDX2001 pharmacokinetics
| Arm | Type | Description |
|---|---|---|
| Phase 1a - MDX2001 Dose Escalation | EXPERIMENTAL | Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion or subcutaneous (SC) injection. |
| Phase 1b - Indication Optimization | EXPERIMENTAL | Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion or subcutaneous (SC) injection. |
| Phase 1b - Dose Optimization | EXPERIMENTAL | Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion or subcutaneous (SC) injection. |
| Phase 2a - Cohort Expansion | EXPERIMENTAL | Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion or subcutaneous (SC) injection at the recommended Phase 2 dose. |
| Name | Type | Description |
|---|---|---|
| MDX2001 | DRUG | MDX2001 intravenous infusion or subcutaneous (SC) injection. |
Inclusion Criteria: * Patients must be ≥ 18 years of age * Histologically or cytologically confirmed diagnosis of metastatic solid tumors * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion...
MDX2001 is an investigational small molecule drug being developed by Opko Health Inc. for advanced solid tumors, including biliary tract cancer. It is in Phase 1 clinical development and is designed to target Trop2, a protein expressed on certain tumor cells. It has not been established as an approved therapy.
MDX2001 is being studied for biliary tract cancer as part of a broader Phase 1 program in advanced solid tumors. The trial also enrolls patients with cholangiocarcinoma and gallbladder cancer, along with many other tumor types. Its use in biliary tract cancer remains investigational and is limited to clinical research.
MDX2001 targets Trop2, a cell surface protein. By binding this target, the small molecule is intended to act on Trop2-expressing tumor cells. Trop2 is the molecular target named for the program, and the compound is being evaluated in patients with advanced solid tumors whose cancers may express this protein.
MDX2001 is being developed by Opko Health Inc., which trades under the ticker OPK. The company is running the Phase 1 program for the drug in advanced solid tumors, including biliary tract cancer, in the United States.
MDX2001 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The ongoing Phase 1 study is a dose escalation and dose expansion trial evaluating the drug in patients with advanced solid tumors, including biliary tract cancer.
MDX2001 is being evaluated in the Phase 1 trial NCT06239194, a dose escalation and dose expansion study in patients with advanced solid tumors. The trial is recruiting in the United States, enrolls adults 18 years and older, and has a planned enrollment of 330 participants across many cancer types, including biliary tract cancer.