Myricx Pharma Limited
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.
Inclusion Criteria: * Male and female patients aged 18 years-or older at the time of signature of the informed consent form. * Patients with advanced/metastatic cancer, with measurable disease as determined by RECIST v1.1 or the Prostate Cancer Clinical Trials Working Group 3 (for mCRPC only) as per Investigator discretion. Note: Patients with mCRPC can be enrolled without measurable disease but must have a minimum of 2 bone lesions and increased PSA. * Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors in patients with relapsed or refractory so…
Anti-B7-H3 ADC