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.
Participants in dose escalation cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: urothelial cancer, colorectal cancer (CRC), gastric or gastroesophageal junction (GEJ) cancer, esophageal cancer, or pancreatic carcinoma that is refractory to standard therapy, or for which standard therapy does not exist, has proven to be intolerable, or has been refused by the participant.
Participants in expansion cohorts must have histologically proven, unresectable, locally advanced or metastatic solid tumors
Urothelial cancer with progression following platinum-containing chemotherapy for metastatic or locally advanced/unresectable cancer, or within 12 months from completion of neo-adjuvant or adjuvant platinum-containing chemotherapy for localized muscle-invasive cancer.
Gastric/GEJ carcinoma with progression during or following at least 1 systemic therapy.
Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
Active brain metastases or leptomeningeal metastases.
Prior stem cell, tissue, or solid organ transplant.
Another malignancy that required treatment within the past 2 years, with the exception of those with a negligible risk of metastasis or death such as adequately treated non-melanomatous skin cancer, localized prostate cancer (Gleason Score < 6), or carcinoma in situ.
Sequential
MGC030
Biological/VaccineAntibody-drug conjugate
13
Treatment groupsSee each treatment group below.
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.
Mean concentrations MGC030 antibody-drug conjugate, total antibody and unconjugated payload.
Number of Participants Who Develop Anti-Drug Antibodies to MGC030
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.
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.
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