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NCT03436563 · ClinicalTrials.gov registry record · Phase 1

M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
4
Enrollment target

NCT03436563: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT03436563 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03436563, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
4 participants
Enrollment target

Study Summary

This phase Ib/II trial studies how well anti-PD-L1/TGFbetaRII fusion protein M7824 (M7824) works in treating patients with colorectal cancer (or with other solid tumors with microsatellite instability) that has spread to other places in the body or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as M7824, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Primary Outcome

Defined as the percentage of somatic mutations, ctDNA that is eliminated in blood as well as no appearance of any new somatic mutations following six doses of BA in the study participants.

Interventions

  • BIOLOGICAL Anti-PD-L1/TGFbetaRII Fusion Protein M7824

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2018-03-07
Est. Completion 2023-08-08
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT03436563 record still lists

NCT03436563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which Anti-PD-L1/TGFbetaRII Fusion Protein M7824 is the first listed.

NCT03436563 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03436563 about?

NCT03436563 is a clinical study titled "M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability". This phase Ib/II trial studies how well anti-PD-L1/TGFbetaRII fusion protein M7824 (M7824) works in treating patients with colorectal cancer (or with other solid tumors with microsatellite instability) that has spread to other places in the body or cannot be removed by surgery. Immunotherapy with mo...

What is the current status of trial NCT03436563?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2018-03-07. Estimated completion is 2023-08-08.

What interventions are being tested in trial NCT03436563?

The interventions under investigation include: Anti-PD-L1/TGFbetaRII Fusion Protein M7824 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03436563?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03436563's enrollment target sits among peer trials

4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03436563, the US trial registry maintained by the National Library of Medicine. NCT03436563 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.