M7437 for Solid Tumors

Not yet recruiting at 7 trial locations
UM
CC
Overseen ByCommunication Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: EMD Serono Research & Development Institute, Inc.
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 tests a new drug, M7437, to determine its safety and effectiveness for individuals with certain advanced solid tumors. It targets cancers such as non-small cell lung cancer, triple-negative breast cancer, ovarian cancer, and others unresponsive to standard treatments. The trial has two parts: first, to identify the right dose, and then to evaluate its effectiveness. For those struggling with these cancers and finding current treatments ineffective, this trial might be suitable. Participants must have good overall health, particularly regarding blood, liver, and kidney function. 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 this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that M7437 is likely to be safe for humans?

Research has shown that M7437 is undergoing safety testing in individuals with certain solid tumors. This marks the first study of M7437 in humans, so limited safety information is currently available. As an early-stage trial, the primary goal is to assess the safety of M7437 and determine how well participants tolerate various doses. Early trials like this are crucial for understanding human reactions to the treatment and identifying any side effects. Although detailed safety information from other studies is not yet available, this trial will offer important insights into the safety of M7437 in humans.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about M7437 for solid tumors because it offers a novel approach by targeting specific pathways that current treatments might not address. Unlike traditional therapies like chemotherapy and radiation, which can affect both cancerous and healthy cells, M7437 is designed to selectively target tumor cells, potentially reducing side effects and improving patient outcomes. This targeted mechanism of action could revolutionize the way we treat solid tumors, offering more effective and less harmful solutions for patients.

What evidence suggests that M7437 might be an effective treatment for solid tumors?

Research has shown that M7437 is an experimental treatment for certain solid tumors, such as some types of lung and breast cancer. It delivers a cancer-fighting drug directly to tumor cells by using a specific marker called Ly6E to locate them. This method aims to make treatment more precise, potentially leading to better patient outcomes. Although specific data on its effectiveness is not yet available, its design appears promising. Participants in this trial will join either a dose-escalation cohort or a dose-expansion cohort to evaluate the effectiveness and safety of M7437.16789

Who Is on the Research Team?

MR

Medical Responsible

Principal Investigator

EMD Serono Research & Development Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors like lung, breast, stomach, ovarian cancer or squamous cell carcinoma. They must have high Ly6E expression and be unresponsive to standard treatments or unsuitable for them. Participants need to be relatively active (ECOG ≤1) and have normal blood, liver, and kidney function.

Inclusion Criteria

* Other protocol defined inclusion criteria may apply
My advanced cancer is known to have high Ly6E expression and cannot be treated with surgery or standard therapies.
I have non-small cell lung cancer.
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 M7437 to evaluate safety and tolerability

8-12 weeks

Dose-expansion

Participants receive the determined safe dose of M7437 to further evaluate clinical activity

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • M7437

Trial Overview

The study tests M7437's safety and effectiveness in treating various cancers with Ly6E expression. It's a first-in-human study looking at how the body processes the drug and its preliminary effects on shrinking or controlling tumor growth.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 2: Dose-Expansion CohortExperimental Treatment1 Intervention
Group II: Part 1: Dose-escalation CohortExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials
86
Recruited
22,700+

Miguel Fernández Alcalde

EMD Serono Research & Development Institute, Inc.

Chief Executive Officer

Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School

Danny Bar-Zohar

EMD Serono Research & Development Institute, Inc.

Chief Medical Officer since 2022

MD

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Industry Sponsor

Trials
60
Recruited
7,900+

Danny Bar-Zohar

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Chief Executive Officer

MD

Danny Bar-Zohar

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Chief Medical Officer since 2022

MD

Citations

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