Testing MGC028 in patients with advanced solid tumors

A Phase 1, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC028 in Participants With Advanced Solid Tumors

This study is testing a new treatment called MGC028 to see if it is safe and can help adults with advanced solid tumors that can't be removed or have spread.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: MacroGenics (Industry-sponsored)
• Drugs / interventions: chimeric antigen receptor, chemotherapy, radiation
• Locations: 7 sites (San Francisco, California and 6 other locations)
• Trial ID: NCT06723236 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults with relapsed or refractory advanced solid tumors such as NSCLC adenocarcinoma, cholangiocarcinoma, pancreatic carcinoma, or colorectal carcinoma.

Not a fit: Patients with tumors that are resectable or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar approaches targeting advanced solid tumors, but the specific use of MGC028 is novel.

Eligibility criteria

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 this trial is running

San Francisco, California and 6 other locations

• 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)
• South Texas Accelerated Research Therapeutics (START) Mountain Region — West Valley City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Global Trial Manager

Conditions Advanced Solid Tumors; NSCLC Adenocarcinoma; Cholangiocarcinoma; Pancreatic Carcinoma; Colorectal Carcinoma