Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MDX2001 · 1 trial · 16 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. |
| Phase 1b - Indication Optimization | EXPERIMENTAL | Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion. |
| Phase 1b - Dose Optimization | EXPERIMENTAL | Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion. |
| Phase 2a - Cohort Expansion | EXPERIMENTAL | Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose. |
| Name | Type | Description |
|---|---|---|
| MDX2001 | DRUG | MDX2001 intravenous infusion |
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 being studied for the treatment of Biliary Tract Cancer. It is currently in Phase 1 clinical development, with an active trial enrolling patients with advanced solid tumors, including Biliary Tract Cancer, to evaluate its safety and efficacy.
MDX2001 targets Trop2, a protein involved in tumor growth. By targeting Trop2, MDX2001 aims to interfere with cancer cell proliferation. This mechanism is being evaluated in a Phase 1 clinical trial for advanced solid tumors, including Biliary Tract Cancer.
MDX2001 is being developed by Opko Health Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced solid tumors, including Biliary Tract Cancer.
MDX2001 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is a dose escalation and dose expansion study in patients with advanced solid tumors, including Biliary Tract Cancer.
MDX2001 is being studied in a Phase 1 clinical trial with the identifier NCT06239194. This trial is a dose escalation and dose expansion study in patients with advanced solid tumors, including Biliary Tract Cancer. The trial is currently recruiting participants in the United States.
MDX2001 is a distinct investigational drug being developed by Opko Health Inc. It is not known to be the same as any other marketed or investigational drug. Its unique mechanism targets Trop2, and it is being evaluated for the treatment of advanced solid tumors.