A Study of MGC028 in Participants With Advanced Solid Tumors

Launched by MACROGENICS · Dec 4, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called MGC028 for adults with advanced solid tumors, including specific types of lung cancer, bile duct cancer, and pancreatic cancer. The main goals are to understand how safe MGC028 is, what side effects it may cause, and whether it can help shrink tumors or keep them from growing. Participants will be monitored closely throughout the study to see how well they respond to the treatment and to manage any side effects.

To be eligible for this trial, participants must have certain types of cancer that have not responded to standard treatments or for which those treatments are not available. They should also have measurable disease, meaning there is a way to track the tumor's size. During the trial, participants will receive MGC028 every three weeks, undergo health checks, and provide blood samples for testing. The study is currently looking for participants aged 65 to 74, and it’s important for those who can become pregnant to use effective birth control during the trial. Overall, this study aims to find out more about a promising new treatment option for patients with challenging cancers.

Gender

ALL

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.