M7437 for Solid Tumors
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose-escalation
Participants receive escalating doses of M7437 to evaluate safety and tolerability
Dose-expansion
Participants receive the determined safe dose of M7437 to further evaluate clinical activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
EMD Serono Research & Development Institute, Inc.
Lead Sponsor
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
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
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/8580cf944478832d/nct07356791-intravesical-adenovirus-injection-high-risk-bladder-cancerPhase II Prospective Cohort Study of Intravesical Recombinant ...
The long-term outcome shows that about 20% -25% of these patients will die of bladder cancer. Since the beginning of the 21st century, after obtaining positive ...
3.
ichgcp.net
ichgcp.net/amp/clinical-trials-registry/research/list?term=Cell%20and%20Tissue%20Based%20Therapy&page=6Search results for Cell and Tissue Based Therapy - Clinical Trials ...
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors. Advanced Solid Tumors. NCT07361094. Recruiting. Autologous CD19/BCMA Dual-Target CAR-T for ...
Systematic review and meta-analysis of molecular tumor ...
Comparative data showed improved outcomes for MTB-treated patients, with hazard ratios of 0.46 (0.28–0.76, p < 0.001) for OS in 19 and 0.65 ( ...
5.
merckgroup.com
merckgroup.com/investors/events-and-presentations/conferences-and-roadshows/2024/en/R_D%20Update%20call%202024%20-%20FINAL%20-%20EN.pdfR&D Update call 2024 - FINAL
Phase II data: OS at 5 years: addition of xevinapant to. SoC chemoradiotherapy reduced the risk of death by more than half (HR 0.47). Most ...
J&J's new trispecific play | ApexOnco
Solid tumours, 26 Dec 2025. M7437, Ly6E ADC, Merck KGaA, Solid tumours known to have high Ly6E expression, 2 Jan 2026. PLB-002, Claudin6 ADC ...
R&D Update call 2024 - FINAL
Phase II data: OS at 5 years: addition of xevinapant to. SoC chemoradiotherapy reduced the risk of death by more than half (HR 0.47). Most ...
M7437 in Advanced Solid Tumors - Clinical Trials Registry
The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical ...
A Phase I study of DLYE5953A, an anti-LY6E antibody ... - PMC
This study characterized the safety, pharmacokinetics, immunogenicity, potential biomarkers, and anti-tumor activity of DLYE5953A in patients with metastatic ...
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