MX006 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a Phase 1a/1b, multicenter, open-label, first-in-human (FIH) study with MX006 treatment in patients with selected tumor types known to express B7-H3. The study will include 2 parts:
* Dose-escalation (Part A)
* Dose-expansion (Part B) A maximum of 120 patients may be enrolled in this study. The primary objective of the dose escalation (PART A) is to evaluate the safety and tolerability of MX006 and determine the maximum-tolerated dose (MTD) and the recommended doses for expansion (RDE) in patients with selected solid tumors; whereas the primary objective of the dose expansion (PART B) is to evaluate the safety and tolerability of MX006 at the dose level (s) recommended in Part A.
Who Is on the Research Team?
Steen Lisby, MD
Principal Investigator
Myricx Pharma
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic solid tumors that have B7-H3 protein. Participants should have tried standard treatments or have no other good options, and must be healthy enough overall to join.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- MX006
Trial Overview
The study tests a new drug called MX006 in people with certain cancers. It will first find the safest dose (Part A), then treat more patients at that dose to further check safety and effects (Part B).
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Dose-expansion (Part B): Part B will commence in patients with selected tumor cohorts after available data is assessed from Part A. For dose expansion patients may be randomized to three dose cohorts.
Dose-escalation (Part A): Patients with solid tumors known to express B7-H3 will be included in the dose-escalation phase in which the MTD and/or RDE/RDEs of MX006 monotherapy will be determined.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Myricx Pharma Limited
Lead Sponsor
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