Advanced Solid TumorsPhase 1NCT07360314
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
A Phase 1 study testing M7437 in people with Advanced Solid Tumors, run by EMD Serono Research & Development Institute, Inc. at 9 sites in 4 countries.
Trial summary
The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in participants with locally advanced or metastatic solid tumors with known Ly6E expression, including non-small cell lung cancer (NSCLC), triple-negative breast… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- M7437
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 13 Feb 2026to 28 Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants have histologically proven advanced solid tumors with known prevalent and high Ly6E expression, Disease characteristic: Participants should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or for which no standard therapy is judged appropriate by the Investigator.
- For each tumor type, participants have received prior lines of therapy, where locally available:
- Non-small cell lung cancer (nonsquamous or squamous)
- Triple-negative breast cancer
- Squamous cell carcinoma of head and neck
- Pancreatic ductal adenocarcinoma
Show all 11Show fewer
- Gastric cancer
- Epithelial ovarian cancer
- Participants with ECOG Performance Status (ECOG) less than and equal to (<=) 1
- Participants must have blood, liver, and kidney function within safe levels.
- Other protocol defined inclusion criteria may apply
Who cannot join
- Participant has a history of another malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hyperplasia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years before the date of enrollment). History of hematopoietic allogenic transplantation.
- Participants with known brain metastases, except those meeting both of the following criteria:
- All brain metastases have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment.
- No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable).
- Participants with diarrhea (liquid stool) or ileus Grade more than (>) 1 within 1 week of Cycle1Day1.
- Participants with active chronic inflammatory bowel disease and/or bowel obstruction.
- Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day1.
- Other protocol defined exclusion criteria may apply.
Trial locations and contacts
9 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 4 countries
United States4 sites, 4 recruiting
- Recruiting
NEXT Houston
Galveston, Texas, 77001
Jennifer M Segar
- Recruiting
Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center
Huntersville, North Carolina, 28078
704-947-6599
John D Powderly
- Recruiting
Yale University - Yale University School of Medicine
New Haven, Connecticut, 06510
203-785-6221
Patricia M LoRusso
- Recruiting
NEXT Oncology - PARENT
San Antonio, Texas, 78229
210-595-5670
Ildefonso Ismael Rodriguez Rivera
Canada2 sites, 2 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto
Spreafico
Anna Spreafico
- Not yet recruiting
BC Cancer - Vancouver - BC Cancer Agency
Vancouver
6048776000 ext. 673226
Anna Tinker
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Universitari Vall d'Hebron - VHIO - Oncology - Phase I Unit
Barcelona, 08035
Elena Garralda Cabanas
- Recruiting
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Madrid
+34666209969
Valentina Boni
Japan1 site, 1 recruiting
- Recruiting
National Cancer Center Hospital
Tokyo
+81335422511
Noboru Yamamoto
About this study
Official title: A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With 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 participants with locally advanced or metastatic solid tumors with known Ly6E expression, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), epithelial ovarian carcinoma (EOC), squamous cell carcinoma of the head and neck (SCCHN), pancreatic ductal adenocarcinoma (PDAC), and gastric cancer (GC).
- Conditions
- Advanced Solid Tumors
- Being tested
- M7437
- Keywords
- Ly6E expression, Topoisomerase I inhibitor (TOP1i), NSCLC, Breast cancer, Gastric cancer, Head and neck squamous cell carcinoma, Ovarian cancer, Pancreatic ductal adenocarcinoma, Systemic antibody-drug conjugate therapy (ADC) therapy
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms, Squamous Cell Carcinoma of Head and Neck, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M7437Drug
Participants will receive M7437 as an intravenous infusion at a dose corresponding to their assigned cohort. Dose escalation will occur between cohorts, with 3-4 participants enrolled at each dose level before proceeding to the next higher dose.
M7437Drug
Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose-escalation Cohort | Experimental | Not described Receives: Drug: M7437 |
| Part 2: Dose-Expansion Cohort | Experimental | Not described Receives: Drug: M7437 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs)
Measured: DLT period is 21 days (cycle 1)
Dose-escalation Cohort: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) and Adverse Event (AEs)
Measured: Up to end of Part 1 of study (approximately 1 year 8 months)
Secondary outcomes (3)
Dose-escalation Cohort: Plasma Concentration of M7437
Measured: Cycle 1 Day 1: Pre-dose, 0.25, 6, 24, 96, 168 and 336 hours post-dose; Cycle 3 Day 1: Pre-dose, 0.25, 6 and 168 hours post-dose; Pre-dose at Day 1 of Cycles 2, 4, 6, 8 until end of treatment (approximately 1 year 8 months) (Each Cycle length=21 days)
Dose-escalation Cohort: Overall Response (OR) According to Response Evaluation Criteria inSolid Tumor (RECIST) version 1.1 criteria as Assessed by Investigator
Measured: From the date of first documented complete response (CR) or partial response (PR), whichever occurs first, until the first documented disease recurrence or progressive disease (PD) (assessed upto [approximately 1 year 8 months])
Change From The Baseline Qtc (Δqtc) At Predefined Timepoints Based on Triplicate Electrocardiogram (ECG) Measurements
Measured: Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 5, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 3 Day 1 (each cycle is of 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start13 Feb 2026
- Primary completion28 Sep 2028 (estimated)
- Study completion28 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Research & Development Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360314
- Sponsor's protocol ID
- MS743701_0001
- Other IDs
- 176325, 2025-523232-39-00, jRCT2031250678, 2025
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07360314
- Acronym / sponsor ID
- MS743701_0001
- Conditions
- Advanced Solid Tumors
- Keywords
- Ly6E expression, Topoisomerase I inhibitor (TOP1i), NSCLC, Breast cancer, Gastric cancer, Head and neck squamous cell carcinoma, Ovarian cancer, Pancreatic ductal adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 28 Sep 2028 (estimated)
- Study completion
- 28 Mar 2029 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in participants with locally advanced or metastatic solid tumors with known Ly6E expression, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), epithelial ovarian carcinoma (EOC), squamous cell carcinoma of the head and neck (SCCHN), pancreatic ductal adenocarcinoma (PDAC), and gastric cancer (GC).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose-escalation Cohort | Experimental | Drug: M7437 |
| Part 2: Dose-Expansion Cohort | Experimental | Drug: M7437 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants have histologically proven advanced solid tumors with known prevalent and high Ly6E expression, Disease characteristic: Participants should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or for which no standard therapy is judged appropriate by the Investigator.
- For each tumor type, participants have received prior lines of therapy, where locally available:
- Non-small cell lung cancer (nonsquamous or squamous)
- Triple-negative breast cancer
- Squamous cell carcinoma of head and neck
Key exclusion criteria (8 listed)
- Participant has a history of another malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hyperplasia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years before the date of enrollment). History of hematopoietic allogenic transplantation.
- Participants with known brain metastases, except those meeting both of the following criteria:
- Participants with diarrhea (liquid stool) or ileus Grade more than (>) 1 within 1 week of Cycle1Day1.
- Participants with active chronic inflammatory bowel disease and/or bowel obstruction.
- Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M7437Participants will receive M7437 as an intravenous infusion at a dose corresponding to their assigned cohort. Dose escalation will occur between cohorts, with 3-4 participants enrolled at each dose level before proceeding to the next higher dose. | Drug | Part 1: Dose-escalation Cohort |
| M7437Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1. | Drug | Part 2: Dose-Expansion Cohort |
Primary outcome
Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs)
Time frame: DLT period is 21 days (cycle 1)
Dose-escalation Cohort: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) and Adverse Event (AEs)
Time frame: Up to end of Part 1 of study (approximately 1 year 8 months)
3 secondary outcomes
Dose-escalation Cohort: Plasma Concentration of M7437
Time frame: Cycle 1 Day 1: Pre-dose, 0.25, 6, 24, 96, 168 and 336 hours post-dose; Cycle 3 Day 1: Pre-dose, 0.25, 6 and 168 hours post-dose; Pre-dose at Day 1 of Cycles 2, 4, 6, 8 until end of treatment (approximately 1 year 8 months) (Each Cycle length=21 days)
Dose-escalation Cohort: Overall Response (OR) According to Response Evaluation Criteria inSolid Tumor (RECIST) version 1.1 criteria as Assessed by Investigator
Time frame: From the date of first documented complete response (CR) or partial response (PR), whichever occurs first, until the first documented disease recurrence or progressive disease (PD) (assessed upto [approximately 1 year 8 months])
Change From The Baseline Qtc (Δqtc) At Predefined Timepoints Based on Triplicate Electrocardiogram (ECG) Measurements
Time frame: Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 5, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 3 Day 1 (each cycle is of 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Responsible study director
EMD Serono Research & Development Institute, Inc.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M7437 in people with Advanced Solid Tumors, run by EMD Serono Research & Development Institute, Inc. at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada, Spain, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US Medical Information (888-275-7376, eMediUSA@emdserono.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs) (time frame: DLT period is 21 days (cycle 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.