A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors
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.
Arms & interventions
- BiologicalMGC026 Dose Escalation
Escalating doses of MGC026
- BiologicalMGC026 Dose for Expansion
MGC026 recommended dose for expansion
Outcome measures
Primary
Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest.
Time frame: Throughout the study, up to 135 weeks
Secondary
Overall response rate in advanced solid tumors
Time frame: Throughout the study, up to 135 weeks
Duration of response (DoR) in advanced solid tumors
Time frame: Throughout the study, up to 135 weeks
ORR rate in metastatic castration resistant prostate cancer (mCRPC)
Time frame: Throughout the study, up to 135 weeks
DoR in mCRPC
Time frame: Throughout the study, up to 135 weeks
Mean (standard deviation [SD]) of MGC026 total and conjugated antibody maximum serum concentration (Cmax)
Time frame: Cycle 1 Day 1: at baseline, end of infusion (EOI) approximately 1 hr, 4hrs after EOI, Day 2 and Day 4.
Mean (standard deviation [SD]) of MGC026 unconjugated payload Cmax
Time frame: Cycle 1 Day 1: at baseline, end of infusion (EOI) approximately 1 hr, 4hrs after EOI, Day 2 and Day 4.
Mean (SD) of MGC026 total and conjugated antibody area under the time concentration curve (AUC)
Time frame: Cycle 1 Day 1: at baseline, EOI approximately 1 hr, 4hrs after EOI, Day 2, Day 4, Day 8, Day 15, and predose Cycle 2 Day 1
Mean (SD) of MGC026 unconjugated payload AUC
Time frame: Cycle 1 Day 1: at baseline, EOI approximately 1 hr, 4hrs after EOI, Day 2, Day 4, Day 8, Day 15, and predose Cycle 2 Day 1
Number of participants who develop anti-MGC026 antibodies (immunogenicity)
Time frame: Day 1, Day 15, and Day 1 of every 21-day cycle, throughout the study, average of 1 year.
Eligibility criteria
Study locations (7)
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
START Midwest
Grand Rapids, Michigan, 49546
START-New York Long Island
Lake Success, New York, 11042
Providence Cancer Institute
Portland, Oregon, 97213
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Texas Health Science Center at Houston
Houston, Texas, 77030
START Mountain Region
West Valley City, Utah, 84119