The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9.
The main question the study aims to answer is:
* What types of side effects will participants experience when receiving MGC028? * Can MGC028 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 or supplemental cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma (CRC), 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 either
NSCLC adenocarcinoma with
progression on or following anti-PD-1/PD-L1 inhibitor, unless contraindicated
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
MGC028
Biological/VaccineMGC028 is an antibody-drug conjugate targeted against ADAM9.
9
Treatment groupsSee each treatment group below.
Number and Types of Adverse Events (AEs) in Participants Receiving MGC028
Types of AEs include Serious Adverse Events (SAEs), and AEs Leading to Treatment Delay or Discontinuation or Dose Reduction, dose limiting toxicities, and AEs of Special Interest. Observation of side effects determines the highest safe dose for further study
Mean maximum concentration of MGC028 antibody
Measurement of the highest concentration of MGC028 conjugated and total antibody in the bloodstream.
Mean Area Under the Concentration Time Curve of MGC028 antibody
Measurement of the total exposure of MGC028 conjugated and total antibody in the bloodstream.
Number of Participants Who Develop Anti-Drug Antibodies to MGC028
Objective Response Rate (ORR)
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.
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