Testing MGC026 in patients with advanced solid tumors

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

This study is testing a new treatment called MGC026 to see if it can help adults with advanced solid tumors that can't be removed or have spread to other parts of the body.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: MacroGenics (industry)
• Drugs / interventions: chimeric antigen receptor, immunotherapy
• Locations: 12 sites (Los Angeles, California and 11 other locations)
• Trial ID: NCT06242470 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in adults with advanced solid tumors that are unresectable or metastatic. Participants will receive MGC026 through intravenous infusion, with a dose assigned at enrollment, and may undergo up to 35 treatments if they tolerate the drug well and their cancer does not progress. The study includes both a dose escalation phase and a cohort expansion phase, with ongoing monitoring for side effects and cancer progression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable, locally advanced, or metastatic solid tumors, including various types of cancer such as squamous cell carcinoma and non-small cell lung cancer.

Not a fit: Patients with resectable tumors or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: While this approach is novel for MGC026, similar studies targeting advanced solid tumors have shown promise in the past.

Eligibility criteria

Inclusion 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 with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible
* 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 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.

Where this trial is running

Los Angeles, California and 11 other locations

• The Angeles Clinic and Research Institute — Los Angeles, California, United States (RECRUITING)
• START Midwest — Grand Rapids, Michigan, United States (RECRUITING)
• START-New York Long Island — Lake Success, New York, United States (RECRUITING)
• Providence Cancer Institute — Portland, Oregon, United States (RECRUITING)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• University of Texas Health Science Center at Houston — Houston, Texas, United States (RECRUITING)
• START Mountain Region — West Valley City, Utah, United States (RECRUITING)
• ICON Cancer Centre Wesley — Auchenflower, Queensland, Australia (RECRUITING)
• ICON Cancer Centre Kurralta Park — Kurralta Park, South Australia, Australia (RECRUITING)
• Austin Health- Olivia Newton John Cancer Center — Heidelberg, Victoria, Australia (RECRUITING)
• Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (RECRUITING)
• The Royal Marsden NHS Foundation Trust — Sutton, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Global Trial Manager

Conditions: Advanced Solid Tumor, Advanced Cancer, Metastatic Cancer, Squamous Cell Carcinoma of Head and Neck, Non Small Cell Lung Cancer, Small-cell Lung Cancer, Bladder Cancer, Sarcoma