A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

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Trial Details

Sponsor: MacroGenics (industry)

Phase: 1

Start date: March 6, 2024

Planned enrollment: 230

Last updated in HealthScout: Dec 2024

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Investigational Drug AI Analysis

chevron Show for: MGC026 (SYNtecan E)

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Trial ID: NCT06242470
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More trial details at ClinicalTrials.gov More info

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Goal: The primary objective of this Phase 1/1b trial is to evaluate the safety and tolerability of the investigational drug MGC026 in patients with advanced solid tumors. The study also aims to assess the pharmacokinetics, immunogenicity, and preliminary antitumor activity of the drug.

Patients: The trial involves adult participants aged 18 years or older who have unresectable, locally advanced or metastatic solid tumors. Eligible cancers include various types, such as squamous cell cancer of the head and neck, small cell lung cancer, squamous and non-squamous non-small cell lung cancer, colorectal cancer, hepatocellular cancer, and others. Participants must meet certain performance and laboratory parameters and must not be pregnant or breastfeeding.

Design: The structure of the study is non-randomized, consisting of both dose escalation and cohort expansion phases. It is an open-label study, meaning both researchers and participants are aware of the treatment being administered.

Treatments: The study administers MGC026, an investigational drug given by IV infusion, which is intended as a treatment for relapsed or refractory advanced solid tumors. This trial aims to identify a range of safe and effective dosing regimens for the drug, which targets specific tumor types to potentially inhibit cancer growth. Initial preclinical studies suggest MGC026 shows promising antitumor activities, although detailed results in humans are still pending. Participants can receive up to 35 treatments, contingent upon the absence of severe adverse effects or disease progression.

Outcomes: The study's primary outcome is the incidence of adverse and serious adverse events among participants. Secondary outcomes include overall and disease-specific response rates, duration of response in various tumor types, pharmacokinetic measures such as maximum serum concentration and area under the time concentration curve, and the development of anti-MGC026 antibodies.

Burden on patient: This trial is expected to impose a significant burden on patients due to the frequent monitoring requirements typical of a Phase 1 study. Participants will undergo routine laboratory testing, pharmacokinetics blood draws, and monitoring for side effects and cancer progression. The intravenous administration of MGC026 at varying doses necessitates regular hospital visits, exacting vigilance for adverse effects, and compliance with protocol-specified intervals for assessments and treatments, which can be demanding for the patient.

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Sites (11)

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ICON Cancer Centre Wesley

Auchenflower, Queensland, 4066, Australia

No email / No phone

Status: Recruiting

ICON Cancer Centre Kurralta Park

Kurralta Park, South Australia, 5037, Australia

No email / No phone

Status: Recruiting

Austin Health- Olivia Newton John Cancer Center

Heidelberg, Victoria, 3084, Australia

No email / No phone

Status: Recruiting

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

No email / No phone

Status: Recruiting

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

No email / No phone

Status: Recruiting

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

No email / No phone

Status: Recruiting

START Midwest

Grand Rapids, Michigan, 49546, United States

No email / No phone

Status: Recruiting

Providence Cancer Institute

Portland, Oregon, 97213, United States

No email / No phone

Status: Recruiting

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

START Mountain Region

West Valley City, Utah, 84119, United States

No email / No phone

Status: Recruiting

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