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M1231 for Esophageal Cancer
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 from baseline until 6 months
Awards & highlights
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 ~ from baseline until 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Part 1: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs
Part 2: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigators
+2 moreSecondary outcome measures
Part 1: Accumulation Ratio for AUCtau (Racc[AUCtau]) of M1231 (Conjugated Payload), Total Antibody and Free Payload for M1231
Part 1: Accumulation Ratio for Maximum Observed Concentration (Racc[Cmax]) of M1231 (Conjugated Payload), Total Antibody and Free Payload for M1231
Antibodies
+43 moreTrial 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
81 Previous Clinical Trials
30,942 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
439 Previous Clinical Trials
114,892 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
293 Previous Clinical Trials
69,341 Total Patients Enrolled
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