120 Participants NeededMy employer runs this trial

MX006 for Cancer

Recruiting at 6 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 trial explores a new treatment called MX006 for certain advanced or metastatic cancers that express the B7-H3 protein. The main goal is to determine a safe dosage and assess patient tolerance. The trial consists of two parts: the first tests different doses to identify the optimal one, and the second uses that dose to further evaluate safety. Individuals with advanced cancer unresponsive to standard treatments, impacting their daily life, might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Is there any evidence suggesting that MX006 is likely to be safe for humans?

Research has shown that MX006 is being tested for safety and tolerance. Limited information exists on its safety because it is in the early testing stages. Scientists are determining the safe dosage of the drug.

In these early studies, the main goal is to find the maximum dose people can take without serious issues. This phase ensures the drug does not cause harmful side effects. Since MX006 is in its first human trial, detailed safety results from earlier studies are not yet available.

Early trials like this are carefully controlled. Doctors closely monitor for side effects and adjust doses to ensure participant safety. As more information emerges, scientists and doctors will better understand MX006's safety for treating certain types of cancer.12345

Why do researchers think this study treatment might be promising?

Most treatments for cancer focus on killing rapidly dividing cells or blocking specific growth signals. But MX006 works differently, targeting a protein called B7-H3 that is often expressed on the surface of solid tumor cells. This unique mechanism can potentially enhance the immune system's ability to recognize and attack cancer cells directly. Researchers are excited about MX006 because it offers a new way to treat tumors that might not respond well to existing therapies, and it could lead to more personalized and effective cancer treatment options.

What evidence suggests that MX006 might be an effective treatment for cancer?

Research has shown that B7-H3, the target for MX006, often appears in many solid tumors and is linked to poor outcomes. Treatments aimed at B7-H3 have effectively slowed tumor growth. For instance, B7-H3-targeted CAR T cell therapies demonstrated strong antitumor effects, causing tumors to shrink in animal studies. Additionally, antibody-drug conjugates (special drugs that deliver cancer-fighting medication directly to tumor cells) targeting B7-H3 have yielded promising results, with up to 32% of patients with advanced tumors responding to treatment. This trial will evaluate MX006, which targets B7-H3, in two parts: a dose-escalation phase to determine the optimal dose and a dose-expansion phase to further assess its effectiveness. These findings suggest that targeting B7-H3 with MX006 could help treat cancers that have this protein.678910

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.
See 4 more

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%).
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive escalating doses of MX006 to determine the maximum-tolerated dose and recommended doses for expansion

21 days per cycle

Dose-expansion

Participants receive MX006 at the dose levels recommended from the dose-escalation phase

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days for AEs, 90 days for SAEs

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

Citations

Targeting B7-H3 (CD276) for Human Cancer Immunotherapy

Importantly, B7-H3 is highly overexpressed on a wide range of human solid cancers and often correlates with both negative prognosis and poor ...

High frequency of B7-H3 expression in all the cancer types ...

B7-H3 (CD276) is broadly overexpressed across solid tumors and plays active roles in immune evasion, tumor angiogenesis, and metabolic reprogramming. As B7-H3- ...

CAR T Cells Targeting B7-H3, a Pan-Cancer Antigen, ...

Results: B7-H3 CAR T cells mediate significant antitumor activity in vivo, causing regression of established solid tumors in xenograft models including ...

Antibody–drug conjugates show potential in advanced ...

In patients who had received a median of five prior lines of therapy, a response rate of 32% and a disease control rate (DCR) of 71.4% was ...

Data from Allogeneic B7-H3–Targeted CAR Vδ1T-cell ...

This study provides clinical proof of concept for allogeneic B7-H3–targeted CAR-Vδ1T cells as a safe platform with low risk of GVHD and ...

A Study of MX006 in Patients With Advanced and/or ...

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 ...

A Study of MX006 in Patients With Advanced ...

The primary objective of the dose escalation (PART A) is to evaluate the safety and tolerability of MX006 and determine the maximum-tolerated ...

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clinicaltrials.ucsf.edu

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