| ID | Type | Description | Link |
|---|---|---|---|
| 176325 | Other Identifier | IND | |
| 2025-523232-39-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose-escalation Cohort | Experimental |
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| Part 2: Dose-Expansion Cohort | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M7437 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs) | DLT period is 21 days (cycle 1) | |
| Dose-escalation Cohort: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) and Adverse Event (AEs) | Up to end of Part 1 of study (approximately 1 year 8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-escalation Cohort: Plasma Concentration of M7437 | 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 |
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Inclusion Criteria:
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
Gastric cancer
Epithelial ovarian cancer
Exclusion Criteria:
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.
Other protocol defined exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US Medical Information | Contact | 888-275-7376 | eMediUSA@emdserono.com | |
| Communication Center | Contact | +49 6151 72 5200 | service@emdgroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Research & Development Institute, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University - Yale University School of Medicine | Not yet recruiting | New Haven | Connecticut | 06510 | United States |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| M7437 | Drug | Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1. |
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| 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 | 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) |
| Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center | Recruiting | Huntersville | North Carolina | 28078 | United States |
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| NEXT Houston | Recruiting | Galveston | Texas | 77001 | United States |
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| NEXT Oncology - PARENT | Recruiting | San Antonio | Texas | 78229 | United States |
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| Princess Margaret Cancer Centre | Recruiting | Toronto | Canada |
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| BC Cancer - Vancouver - BC Cancer Agency | Not yet recruiting | Vancouver | Canada |
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| National Cancer Center Hospital | Recruiting | Tokyo | Japan |
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| Hospital Universitari Vall d'Hebron - VHIO - Oncology - Phase I Unit | Not yet recruiting | Barcelona | 08035 | Spain |
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| NEXT Madrid - Hospital Universitario Quironsalud Madrid | Not yet recruiting | Madrid | Spain |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |