A Study of MGC026 in Participants With Advanced Solid Tumors

Launched by MACROGENICS · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called MGC026 for adults with advanced solid tumors, which are types of cancer that have spread or cannot be removed through surgery. The study aims to find out if MGC026 is safe, how the body processes it, and whether it can help shrink tumors or improve patients' conditions. Participants will receive MGC026 through an intravenous (IV) infusion, meaning it will be delivered directly into their bloodstream. They may receive up to 35 treatments as long as they don’t experience severe side effects and their cancer does not get worse.

To join the trial, participants must be at least 18 years old and have specific types of cancer, such as lung, bladder, or skin cancer, that are not amenable to surgery. They should also be willing to use effective birth control during the study and for several months afterward. Throughout the trial, participants will be closely monitored for any side effects and their cancer's progress. This trial is currently looking for volunteers, so if you or someone you know fits the eligibility criteria, it could be an opportunity to explore a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults ≥ 18 years old, able to provide informed consent
• • Adequate performance and laboratory parameters
• • 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 cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.
• • 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.
• Exclusion Criteria:
• • 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 (Gleason Score \< 6), or carcinoma in situ.
• • 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 imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.
• • Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.
• • 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.