A Study of MGC028 in Participants 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will * Undergo screening procedures to determine eligibility * Receive study treatments initially every 3 weeks. * Have blood samples taken for routine and research tests * Have other examinations to check heart and lung function, and general health status * Be asked about any side effects that may be happening or other medications you are taking."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests MGC028 in adults with solid tumors that have come back or resist treatment, cannot be removed by surgery, and have spread nearby or to other parts of the body. These tumor types are known to make a protein called ADAM9. Researchers will look for a safe dose, check side effects, and see if the drug shrinks tumors or slows their growth.
The goal of this clinical trial is 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). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9. The main question the study aims to answer is: * What types of side effects will participants experience when receiving MGC028? * Can MGC028 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors? Participants will * Undergo screening procedures to determine eligibility * Receive study treatments initially every 3 weeks. * Have blood samples taken for routine and research tests * Have other examinations to check heart and lung function, and general health status * Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary. * Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- In the dose-testing or added groups, you must have lung adenocarcinoma, bile duct cancer, colon or rectal cancer, or pancreatic cancer confirmed by a tissue test. The cancer must have spread nearby or farther and cannot be removed by surgery. Standard treatment must have failed, be unavailable, cause side effects you cannot tolerate, or have been refused.
- In the lung cancer expansion group, cancer must have grown during or after PD-1/PD-L1 treatment, which helps the immune system fight cancer, unless it is unsafe for you. If your cancer has gene changes that can be treated, it must also have grown during or after treatment aimed at them. You may have had no more than 2 rounds of different chemotherapy treatments for advanced cancer.
- In the pancreatic cancer expansion group, you must have had at least 1 drug treatment that travels through the body, and no more than 2 rounds of different chemotherapy treatments for advanced cancer.
- In the colon or rectal cancer expansion group, cancer must have grown during or after fluoropyrimidine chemotherapy, oxaliplatin, and irinotecan, unless unsafe, refused, or unavailable. If your cancer has gene changes that can be treated, it must also have grown after treatment aimed at them. For advanced cancer, you may have had no more than 2 different chemotherapy treatments and 4 different drug treatment plans in all.
- You must have at least one tumor that can be measured under the study's rules.
- You must have a stored tumor sample or agree to a biopsy, a procedure to take a new tumor sample.
- Your physical health and lab test results must meet the study's requirements.
- If you can become pregnant, you must use highly effective birth control. You must not be pregnant, planning pregnancy, or breastfeeding.
Who can't join
- A medical or mental health condition that keeps you from safely receiving treatment or following study steps.
- Active cancer spread to the brain or the tissue around the brain and spinal cord.
- A past stem cell, tissue, or organ transplant.
- Another cancer that needed treatment in the past 2 years. Some cancers with very low risk of spread or death are allowed.
- An active infection caused by a virus, bacteria, or fungus.
- Past cancer treatment aimed at ADAM9.
- Within 4 weeks before study treatment: major surgery, radiation to the lungs or middle of the chest, a live-virus vaccine, cancer drugs that travel through the body, CAR-T cell therapy (treatment using changed immune cells), or an experimental treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (7)
CA
- UCSF - Helen Diller Family Cancer Center · San Francisco, CA 94115Pamela Munster · Principal investigatorMore trials in San Francisco
MA
- Mass General Brigham · Boston, MA 02114Harshaband Singh · Principal investigatorMore trials in Boston
- Dana Farber/Harvard Cancer Center · Boston, MA 02115Kimberly Perez · Principal investigatorMore trials in Boston
MI
- South Texas Accelerated Research Therapeutics (START) Midwest · Grand Rapids, MI 49546Manish Sharma · Principal investigatorMore trials in Grand Rapids
NY
- Icahn School of Medicine at Mt. Sinai · New York, NY 10029Deborah Doroshow · Principal investigatorMore trials in New York
TX
- South Texas Accelerated Research Therapeutics (START) San Antonio · San Antonio, TX 78229Drew Rasco · Principal investigatorMore trials in San Antonio
UT
- South Texas Accelerated Research Therapeutics (START) Mountain Region · West Valley City, UT 84119Justin Call · Principal investigatorMore trials in West Valley City