Advanced Solid Tumors study: MGC028
Official title A Study of MGC028 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06723236
What this study is testing
What is MGC028?
MGC028 is an investigational antibody-drug conjugate being studied for advanced solid tumors.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether MGC028 is safe and how much of it people can tolerate. It also looks at whether the drug can stop cancer from growing or shrink tumors.
- Who it's for
- You may be able to join if you are an adult with advanced solid tumors that cannot be removed, and your cancer cells show ADAM9.
- What's involved
- You will receive MGC028 every three weeks. The study will take blood samples, check your heart and lung health, and ask about side effects. Your doctor will monitor your tumor response and treat any side effects.
- Time commitment
- The study lasts about 3 months of treatment, with regular visits every 3 weeks for drug administration and health checks.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants in dose escalation or supplemental cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor...
- 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
You likely can't join if
- Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study...
- 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...
- Active viral, bacterial, or fungal infection
- Prior treatment with ADAM9 targeted agent for cancer.
See the full eligibility 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...
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States; New York, New York, United States; San Antonio, Texas, United States; West Valley City, Utah, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.