Testing MGC028 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and tolerability of MGC028 in adult participants with advanced solid tumors that are unresectable or metastatic and express ADAM9. Participants will undergo screening to determine eligibility and receive MGC028 treatment every three weeks, with assessments of side effects and overall health. The study will also monitor the drug's effectiveness in controlling disease progression or shrinking tumors. Blood samples and health examinations will be conducted throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• UCSF - Helen Diller Family Cancer Center
  San Francisco, California, United States Recruiting
• Mass General Brigham
  Boston, Massachusetts, United States Recruiting
• Dana Farber/Harvard Cancer Center
  Boston, Massachusetts, United States Recruiting
• South Texas Accelerated Research Therapeutics (START) Midwest
  Grand Rapids, Michigan, United States Recruiting
• Icahn School of Medicine at Mt. Sinai
  New York, New York, United States Recruiting
• South Texas Accelerated Research Therapeutics (START) San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Global Trial Manager
• Email: info@macrogenics.com
• Phone: 301-251-5172

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.