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RECRUITING
NCT07807241
PHASE1

A Study of MX006 in Patients With Advanced and/or Metastatic Tumors Known to Express B7-H3

Sponsor: Myricx Pharma Limited

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 1a/b, Open-label, Dose-escalation and Dose-expansion, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of MX006 in Patients With Selected Advanced Solid Tumor Types Known to Express B7-H3

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-07-20

Completion Date

2030-07

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

DRUG

MX006

Anti-B7-H3 ADC

Locations (4)

Florida Cancer Specialists

Sarasota, Florida, United States

MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States