A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors
MacroGenics
Summary
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. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 can…
Interventions
- BiologicalMGC026 Dose Escalation
Escalating doses of MGC026
- BiologicalMGC026 Dose for Expansion
MGC026 recommended dose for expansion
Locations (12)
- The Angeles Clinic and Research InstituteLos Angeles, California
- START MidwestGrand Rapids, Michigan
- START-New York Long IslandLake Success, New York
- Providence Cancer InstitutePortland, Oregon
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- University of Texas Health Science Center at HoustonHouston, Texas