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

Conditions

• Advanced and/or Metastatic Solid Tumors Known to Express B7-H3

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MX006 — DRUG
  Anti-B7-H3 ADC

Study Details

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.

Key Dates

First listed

Sep 8, 2026

Start date

Jul 20, 2026

Status verified

Sep 2026

Primary completion

Jul 31, 2030

Completion

Jul 31, 2030

Study Design

Enrollment

120 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: Dose escalation
  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.
• Experimental: Part B: Dose-expansion
  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.

Primary Outcome Measure

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) for patients treated with MX006 [ Time Frame: From ICF signature until 30 days (AEs) and 90 days (SAEs) after last dose of MX006 ]

Central Contacts

• Myricx Pharma Contact for Clinical Trial Information
  +44 20 3103 6865
  [email protected]
• Myricx Pharma Contact for Clinical Trial Information (Back-up)
  +44 20 3103 6865
  [email protected]

Locations (4)

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