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NCT04695847 · ClinicalTrials.gov registry record · Phase 1

M1231 in Participants With Solid Tumors

A Phase 1 study of Non-Small Cell Lung Cancer and Esophageal Cancer, sponsored by EMD Serono Research & Development Institute.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target
3
Study locations

NCT04695847 is a Phase 1 study of Non-Small Cell Lung Cancer and Esophageal Cancer that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 23 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT04695847, a Phase 1 study of Non-Small Cell Lung Cancer and Esophageal Cancer, has completed, sponsored by EMD Serono Research & Development Institute.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target
3
Study locations

Study Summary

This study is to establish a safe and tolerable dose and to investigate pharmacokinetics and the first clinical efficacy signals of M1231 as a single agent in participants with solid tumors (Part 1) and with metastatic Non-small Cell Lung Cancer (NSCLC) and esophageal squamous cell carcinoma (Part 2). Dose escalation will be followed by the dose expansion once the maximum tolerated dose (MTD) or recommended dose for Expansion (RDE) has been defined.

Interventions

  • DRUG M1231

Study Locations (3)

Texas

  • MD Anderson Cancer Center - Clinical Cancer Prevention - Houston
  • NEXT Oncology - San Antonio

Other

  • Princess Margaret Cancer Centre - Toronto

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2021-01-13
Est. Completion 2023-06-23
Phase Phase 1

What the Registry Record Tells You About NCT04695847

The ClinicalTrials.gov registry entry for NCT04695847 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (97% lower). The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which M1231 is the first listed.

NCT04695847 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Texas, Other.

Frequently Asked Questions

What is clinical trial NCT04695847 about?

NCT04695847 is a clinical study titled "M1231 in Participants With Solid Tumors". This study is to establish a safe and tolerable dose and to investigate pharmacokinetics and the first clinical efficacy signals of M1231 as a single agent in participants with solid tumors (Part 1) and with metastatic Non-small Cell Lung Cancer (NSCLC) and esophageal squamous cell carcinoma (Part 2...

What is the current status of trial NCT04695847?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2021-01-13. Estimated completion is 2023-06-23.

What conditions does trial NCT04695847 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Esophageal Cancer, Metastatic Solid Tumors.

What interventions are being tested in trial NCT04695847?

The interventions under investigation include: M1231 (DRUG).

Who is sponsoring clinical trial NCT04695847?

This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04695847 being conducted?

This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.