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M1231 in Participants With Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called M1231 to see if it is safe and effective for patients with advanced cancers, including lung and esophageal cancer. Researchers will study how the drug is processed by the body and its potential to control or reduce the cancer.
Eligible Conditions
- Metastatic Tumor
- Esophageal Cancer
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part 2: Cohort B M1231: Metastatic Esophageal Squamous Cell CarcinomaExperimental Treatment1 Intervention
Participants with metastatic esophageal squamous cell carcinoma will receive M1231 at the dose determined as recommended dose for expansion (RDE) in Part 1.
Group II: Part 2: Cohort A M1231: Metastatic NSCLCExperimental Treatment1 Intervention
Participants with metastatic Non-small Cell Lung Cancer (NSCLC) expressing Epidermal Growth Factor Receptor (EGFR) and Mucin 1 (MUC1) on archival tumor tissue will receive M1231 at the dose determined as recommended dose for expansion (RDE) in Part 1.
Group III: Part 1: M1231Experimental Treatment1 Intervention
Participants with solid tumors for whom no effective standard therapy exists will be included in this Part. Dose escalation of M1231 will be administered as single agent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
M1231
2021
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
85 Previous Clinical Trials
22,710 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
446 Previous Clinical Trials
114,879 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
300 Previous Clinical Trials
61,156 Total Patients Enrolled