A Study Of MGC028 In Participants With Advanced Solid Tumors

Study Overview

A Study of MGC028 in Participants With Advanced Solid Tumors

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.

N/A

Advanced Solid Tumors
NSCLC Adenocarcinoma
Cholangiocarcinoma
Pancreatic Carcinoma
Colorectal Carcinoma

BIOLOGICAL: MGC028

CP-MGC028-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-12-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-13
First Submitted that Met QC Criteria 2024-12-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-15
First Posted (ACTUAL) 2024-12-09	Results First Posted N/A	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cohort 1 Dose level 1 of MGC028, IV	BIOLOGICAL: MGC028 MGC028 is an antibody-drug conjugate targeted against ADAM9.
EXPERIMENTAL: Cohort 2 Dose level 2 of MGC028, IV	BIOLOGICAL: MGC028 MGC028 is an antibody-drug conjugate targeted against ADAM9.
EXPERIMENTAL: Cohort 3 Dose level 3 of MGC028, IV	BIOLOGICAL: MGC028 MGC028 is an antibody-drug conjugate targeted against ADAM9.
EXPERIMENTAL: Cohort 4 Dose level 4 of MGC028, IV	BIOLOGICAL: MGC028 MGC028 is an antibody-drug conjugate targeted against ADAM9.
EXPERIMENTAL: Cohort 5 Dose level 5 of MGC028, IV	BIOLOGICAL: MGC028 MGC028 is an antibody-drug conjugate targeted against ADAM9.
EXPERIMENTAL: Cohort 6 Dose level 6 of MGC028, IV	BIOLOGICAL: MGC028 MGC028 is an antibody-drug conjugate targeted against ADAM9.
EXPERIMENTAL: Expansion Cohort 1 MTD or MAD of MGC028, IV	BIOLOGICAL: MGC028 MGC028 is an antibody-drug conjugate targeted against ADAM9.
EXPERIMENTAL: Expansion Cohort 2 MTD or MAD of MGC028, IV	BIOLOGICAL: MGC028 MGC028 is an antibody-drug conjugate targeted against ADAM9.
EXPERIMENTAL: Expansion Cohort 3 MTD or MAD of MGC028, IV	BIOLOGICAL: MGC028 MGC028 is an antibody-drug conjugate targeted against ADAM9.

Primary Outcome Measures	Measure Description	Time Frame
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	Throughout the study treatment and safety follow up period, up to 25 months

Secondary Outcome Measures	Measure Description	Time Frame
Mean maximum concentration of MGC028 antibody	Measurement of the highest concentration of MGC028 conjugated and total antibody in the bloodstream.	Through Cycle 6 of the study, approximately 18 weeks
Mean Area Under the Concentration Time Curve of MGC028 antibody	Measurement of the total exposure of MGC028 conjugated and total antibody in the bloodstream.	Through Cycle 6 of the study, approximately 18 weeks
Number of Participants Who Develop Anti-Drug Antibodies to MGC028		Throughout the study treatment period, up to 2 years
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.	Throughout the study and follow up period, up to 2.5 years.
Median 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.	Throughout the study and follow up period, up to 2.5 years.
Mean maximum concentration of MGC028 free payload	Measurement of the highest concentration of MGC028 free payload in the bloodstream.	Through Cycle 6 of the study, approximately 18 weeks
Mean Area Under the Concentration Time Curve Total exposure of MGC028 payload	Measurement of the total exposure of MGC028 free payload in the bloodstream	Through Cycle 6 of the study, approximately 18 weeks
Change from baseline in the level of ADAM9 expression in tumor specimens, using immunohistochemistry		Baseline and approximately 28 days after the first dose of MGC028.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Global Trial Manager

Phone Number: 301-251-5172

Email: info@macrogenics.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present
no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease.
Pancreatic cancer

following at least 1 systemic therapy
no more than 2 prior lines of cytotoxic therapy for advanced or metastatic disease.
Colorectal adenocarcinoma with

Progression during or following standard therapy with a fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan unless contraindicated, refused or unavailable
Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI- H/dMMR, if present.
No more that 2 lines of cytotoxic chemotherapy for advanced or metastatic disease
No more than 4 lines of systemic regimens for advanced or metastatic disease
Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.
Participants have acceptable physical condition and laboratory values.
Participants of childbearing potential must agree to use highly effective methods of birth control.
Participants must not be pregnant, planning to be pregnant, or breastfeeding.

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.
Active viral, bacterial, or fungal infection
Prior treatment with ADAM9 targeted agent for cancer.
Prior treatment with major surgery, mediastinal or lung radiation, vaccination with live virus vaccines, systemic cancer treatment, chimeric antigen receptor (CAR)-T cell therapy, or experimental treatment within 4 weeks of the start of study treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Pepi Pencheva, M.D., MacroGenics

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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