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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Escalating doses of MGC026
MGC026 recommended dose for expansion
The Angeles Clinic and Research Institute
Los Angeles, California, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGSTART-New York Long Island
Lake Success, New York, United States
RECRUITINGProvidence Cancer Institute
Portland, Oregon, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGUniversity of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGSTART Mountain Region
West Valley City, Utah, United States
RECRUITINGICON Cancer Centre Wesley
Auchenflower, Queensland, Australia
RECRUITINGICON Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia
RECRUITINGAustin Health- Olivia Newton John Cancer Center
Heidelberg, Victoria, Australia
RECRUITING...and 2 more locations
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
Overall response rate in advanced solid tumors
The objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) is used to estimate the proportion of participants in the Response Evaluable population who achieve best overall response of complete response (CR) or partial response (PR) (called responders). Complete response (CR) is defined as disappearance of all target and non-target lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions, and no new lesions
Time frame: Throughout the study, up to 135 weeks
Duration of response (DoR) in advanced solid tumors
DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first. (RECIST 1.1) is used to classify responses.
Time frame: Throughout the study, up to 135 weeks
ORR rate in metastatic castration resistant prostate cancer (mCRPC)
The ORR per Prostate Cancer Working Group 3 (PCWG3) criteria is estimated as the proportion of participants in the Response Evaluable population who achieve best overall response of CR or PR (called responders).
Time frame: Throughout the study, up to 135 weeks
DoR in mCRPC
DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented progression, per PCWG3 criteria or death from any cause, whichever occurs first.
Time frame: Throughout the study, up to 135 weeks
Mean (standard deviation [SD]) of MGC026 total and conjugated antibody maximum serum concentration (Cmax)
The maximum concentration in the bloodstream at the end of the infusion.
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
The maximum concentration in the bloodstream at the end of the infusion.
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)
Calculated exposure to MGC026
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
Calculated exposure to MGC026
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)
Development of anti-MGC026 antibodies in the bloodstream
Time frame: Day 1, Day 15, and Day 1 of every 21-day cycle, throughout the study, average of 1 year.
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