The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of MGC030. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors of select types. The main question the study aims to answer is: * What types of side effects will participants experience when receiving MGC030? * Can MGC030 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors? Participants will * Undergo screening procedures to determine eligibility * Receive study treatments initially every 3 weeks. * Have blood samples taken for routine and research tests * Have other examinations to check heart and lung function, and general health status * Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary. * Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
314
Antibody-drug conjugate
Number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to dose interruption, AEs leading to dose reduction or treatment discontinuation, does limiting toxicities and AEs of special interest.
Time frame: Throughout the study, estimated duration 2 years.
Mean concentrations MGC030 antibody-drug conjugate, total antibody and unconjugated payload.
Time frame: Throughout the study treatment period, up to 2 years
Number of Participants Who Develop Anti-Drug Antibodies to MGC030
Time frame: Throughout the study treatment period, up to 2 years
Objective response rate
The ORR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is estimated as the proportion of participants in the Response Evaluable Population who achieve Best Overall Response of Complete Response or Partial Response.
Time frame: Throughout the study treatment period, up to 2 years
Duration of Response
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.
Time frame: Throughout the study treatment period, up to 2 years.
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