A Phase I, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC028 in Participants with Advanced Solid Tumors

Study Identifier:
CP-MGC028-01
CT.gov Identifier:
NCT06723236
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

To characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined) in patients with advanced solid tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Non-Small Cell Lung Cancer
  • Bile Duct
  • Pancreas
  • Bowel (Colorectal)
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Cohort 1
    • Read More
  • Drug: Experimental: Cohort 2
  • Drug: Experimental: Cohort 3
  • Drug: Experimental: Cohort 4
  • Drug: Experimental: Cohort 5
  • Drug: Experimental: Cohort 6
  • Drug: Experimental: Expansion Cohort 1
  • Drug: Experimental: Expansion Cohort 2
  • Drug: Experimental: Expansion Cohort 3
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Participants in dose escalation or supplemental cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma (CRC), or pancreatic carcinoma that is refractory to standard therapy, or for which standard therapy does not exist, has proven to be intolerable, or has been refused by the participant.
    • Participants in expansion cohorts must have either
    • NSCLC adenocarcinoma with
    • progression on or following anti-PD-1/PD-L1 inhibitor, unless contraindicated
    • progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present
    • no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease.
    • Pancreatic cancer
    • following at least 1 systemic therapy
    • no more than 2 prior lines of cytotoxic therapy for advanced or metastatic disease.
    • Colorectal adenocarcinoma with
    • Progression during or following standard therapy with a fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan unless contraindicated, refused or unavailable
    • Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI- H/dMMR, if present.
    • No more that 2 lines of cytotoxic chemotherapy for advanced or metastatic disease
    • No more than 4 lines of systemic regimens for advanced or metastatic disease
    • Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
    • Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.
    • Participants have acceptable physical condition and laboratory values.
    • Participants of childbearing potential must agree to use highly effective methods of birth control.
    • Participants must not be pregnant, planning to be pregnant, or breastfeeding.
    Exclusion criteria
    • Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
    • Active brain metastases or leptomeningeal metastases.
    • Prior stem cell, tissue, or solid organ transplant.
    • Another malignancy that required treatment within the past 2 years, with the exception of those with a negligible risk of metastasis or death such as adequately treated non-melanomatous skin cancer, localized prostate cancer (Gleason Score < 6), or carcinoma in situ.
    • Active viral, bacterial, or fungal infection
    • Prior treatment with ADAM9 targeted agent for cancer.
    • Prior treatment with major surgery, mediastinal or lung radiation, vaccination with live virus vaccines, systemic cancer treatment, chimeric antigen receptor (CAR)-T cell therapy, or experimental treatment within 4 weeks of the start of study treatment.

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Justin Call
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer
    Bile Duct
    Pancreas
    Bowel (Colorectal)
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer
    Bile Duct
    Pancreas
    Bowel (Colorectal)
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer
    Bile Duct
    Pancreas
    Bowel (Colorectal)