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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

Study Summary

This trial is to study a new cancer drug, M1231, to see if it is safe and effective. Part 1 will study solid tumors, and Part 2 will study NSCLC and esophageal squamous cell carcinoma. The dose will be increased until the maximum tolerated dose is found.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until 6 months for reporting.

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 more

Secondary 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 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor

76 Previous Clinical Trials

30,837 Total Patients Enrolled

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

436 Previous Clinical Trials

114,633 Total Patients Enrolled

Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

288 Previous Clinical Trials

68,952 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Approximately how many participants has this trial enlisted thus far?

"Affirmative. Clinicaltrials.gov reveals that recruitment for this medical research is still in progress, having first opened on the 13th of January 2021 and most recently updated on 26th October 2022; 84 patients are sought from 3 distinct sites."

Answered by AI

Are there current opportunities to enroll in this scientific experiment?

"Clinicaltrials.gov confirms that this medical research is still accepting participants, which was first announced on January 13th 2021 and last updated October 26th 2022."

Answered by AI