ClinicaliQ Trial Snapshot
- A Study of MX006 in Patients With Advanced and/or Metastatic Tumors Known to Express B7-H3 — Recruiting • Phase I • Oncology • NCT07807241.
- What is being tested: MX006, a novel first-in-human B7-H3-targeted immunotherapy, is being evaluated in a Phase 1a/1b dose-escalation and dose-expansion study in patients with advanced and/or metastatic tumors expressing B7-H3, aiming to establish safety, tolerability, and preliminary efficacy.
- Patient eligibility overview: The trial enrolls patients with selected advanced or metastatic B7-H3-expressing tumor types; specific eligibility criteria include disease stage and biomarker confirmation, with detailed inclusion/exclusion parameters defined for dose-escalation and dose-expansion cohorts.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : * 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 solid tumors known to express B7-H3 who have failed available standard therapy or who are not candidates for standard therapy. * Has adequate bone marrow and organ function within 7 days before the start of study * Has an adequate treatment washout period prior to start of study treatment, defined as: * Major surgery: ≥4 weeks (or 2 weeks for low-invasive cases [e.g., colostomy]). Note: major surgery is defined for example as a surgical procedure that is complex, invasive (e.g., enters a body cavity), is associated with higher risk of complications, and may require general anesthesia and hospitalization. * Radiation therapy: ≥4 weeks (if palliative single site stereotactic radiation therapy,…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.