120 Participants NeededMy employer runs this trial

MX006 for Cancer

Recruiting at 3 trial locations
MP
MP
Overseen ByMyricx Pharma Contact for Clinical Trial Information (Back-up)
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Myricx Pharma Limited
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

SL

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

I have waited long enough after surgery before starting this study treatment.
I have advanced or metastatic cancer that can be measured on scans or tests.
My advanced solid tumor is B7-H3 positive and has not responded to standard treatments.
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Exclusion Criteria

Baseline QTcF >470 msec, complete left bundle branch block (QRS ≥120 msec), or incomplete left bundle branch block based on triplicate 12-lead ECG per local read
I have had non-invasive cancers, except for cervical or non-melanoma skin cancers.
My heart's pumping ability is below normal (less than 45%).
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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

Group I: Part B: Dose-expansionExperimental Treatment1 Intervention
Group II: Part A: Dose escalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Myricx Pharma Limited

Lead Sponsor