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NCT06014658 · ClinicalTrials.gov registry record · Phase 1

Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors

A Phase 1 study of Cancer, sponsored by MBrace Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
130
Enrollment target
17
Study locations

NCT06014658 is a Phase 1 study of Cancer that is actively recruiting participants, run by MBrace Therapeutics. The registered enrollment target is 130 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (96% lower). The trial reports 17 study locations across 14 states.

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The verdict

NCT06014658, a Phase 1 study of Cancer, is actively recruiting participants, sponsored by MBrace Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
130 participants
Enrollment target
17
Study locations

Study Summary

This is a first-in-human (FIH), open label Phase 1/1b / Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment. Phase 1 will identify potential optimal biologically relevant doses (OBRD) and the maximum tolerated dose (MTD) of MBRC-101 at one 1 or more dosing regimens. Phase 1b will evaluate the safety and preliminary clinical activity of MBRC-101 at potential OBRDs. Phase 1 and Phase 1b will both characterize single and multiple-dose PK profiles and evaluate incidence and persistence of anti-MBRC-101 Ab. Phase 2 will evaluate the efficacy of MBRC-101 at the RP2D from Phase1b.

Conditions Studied

Cancer

Interventions

  • DRUG Antibody-Drug Conjugate

Study Locations (17)

Pennsylvania

  • University of Pennsylvania, Abramson Cancer Center - Philadelphia
  • Fox Chase Cancer Center - Philadelphia

South Carolina

  • Medical University of South Carolina (MUSC) - Charleston
  • PRISMA Health, Institute for Translational Oncology - Greenville

Texas

  • NEXT Oncology - Austin
  • NEXT Oncology - Irving

California

  • UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco

Colorado

  • University of Colorado, Anschutz Cancer Pavilion (ACP( - Aurora

Georgia

  • Winship Cancer Institute, Emory University - Atlanta

Illinois

  • University of Chicago Medical Center - Chicago

Indiana

  • Horizon Oncology Research - Lafayette

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2023-11-07
Est. Completion 2026-11
Phase Phase 1

Sponsor

MBrace Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06014658

The ClinicalTrials.gov registry entry for NCT06014658 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (96% lower). The listed sponsor is MBrace Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which Antibody-Drug Conjugate is the first listed.

NCT06014658 reports 17 study locations spanning 14 distinct geographic areas - top geographies include Pennsylvania, South Carolina, Texas.

Frequently Asked Questions

What is clinical trial NCT06014658 about?

NCT06014658 is a clinical study titled "Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors". This is a first-in-human (FIH), open label Phase 1/1b / Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment. Phase 1 will identify potential optimal biologically relevant doses (OBRD) and the maximum tolerated dose (MTD) of MBRC-101 at one 1 or more dosin...

What is the current status of trial NCT06014658?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2023-11-07. Estimated completion is 2026-11.

What conditions does trial NCT06014658 study?

This clinical trial studies the following conditions: Cancer.

What interventions are being tested in trial NCT06014658?

The interventions under investigation include: Antibody-Drug Conjugate (DRUG).

Who is sponsoring clinical trial NCT06014658?

This trial is sponsored by MBrace Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06014658 being conducted?

This trial has 17 study locations across California, Colorado, Georgia, Illinois, Indiana. 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.