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New treatment option for Advanced Solid Tumor
Official title A Study of MGC026 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06242470
What this study is testing
What is MGC026 Dose Escalation?
MGC026 Dose Escalation is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
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
- The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion.
- 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
- Adults ≥ 18 years old, able to provide informed consent
- Adequate performance and laboratory parameters
- Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen...
- Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and...
- Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.
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...
- Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as...
- Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for...
- Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified...
- Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.
- Prior autologous or allogeneic stem cell or solid organ transplant.
See the full eligibility criteria
- Adults ≥ 18 years old, able to provide informed consent
- Adequate performance and laboratory parameters
- Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants...
- Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder...
- Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.
- Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.
- Not 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.
- Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer...
- Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance...
- Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.
- Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.
- Prior autologous or allogeneic stem cell or solid organ transplant.
- Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.
- Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.
- Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
- History of primary immunodeficiency.
- Major trauma or major surgery within 4 weeks of first study drug administration.
- Known hypersensitivity to recombinant proteins.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Grand Rapids, Michigan, United States
- Lake Success, New York, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- West Valley City, Utah, United States
- Auchenflower, Queensland, Australia
- Kurralta Park, South Australia, Australia
- Heidelberg, Victoria, Australia
- Oxford, United Kingdom
- Sutton, United Kingdom
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 - 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?
Study sites include Los Angeles, California, United States; Grand Rapids, Michigan, United States; Lake Success, New York, United States; Portland, Oregon, United States; Houston, Texas, United States; West Valley City, Utah, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.