Clinical Trials/NCT06723236

NCT06723236

Recruiting

Phase 1

A Phase 1, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC028 in Participants With Advanced Solid Tumors

MacroGenics13 sites in 1 country124 target enrollmentFebruary 13, 2025

InterventionsMGC028

DrugsMGC028

Overview

Phase: Phase 1
Intervention: MGC028
Conditions: Not specified
Sponsor: MacroGenics
Enrollment: 124
Locations: 13
Primary Endpoint: Number and Types of Adverse Events (AEs) in Participants Receiving MGC028
Status: Recruiting
Last Updated: 5 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 13, 2025

End Date

April 1, 2027

Last Updated

5 days ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

MacroGenics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.

Arms & Interventions

Cohort 1

Dose level 1 of MGC028, IV

Intervention: MGC028

Cohort 2

Dose level 2 of MGC028, IV

Intervention: MGC028

Cohort 3

Dose level 3 of MGC028, IV

Intervention: MGC028

Cohort 4

Dose level 4 of MGC028, IV

Intervention: MGC028

Cohort 5

Dose level 5 of MGC028, IV

Intervention: MGC028

Cohort 6

Dose level 6 of MGC028, IV

Intervention: MGC028

Expansion Cohort 1

MTD or MAD of MGC028, IV

Intervention: MGC028

Expansion Cohort 2

MTD or MAD of MGC028, IV

Intervention: MGC028

Expansion Cohort 3

MTD or MAD of MGC028, IV

Intervention: MGC028

Outcomes

Primary Outcomes

Number and Types of Adverse Events (AEs) in Participants Receiving MGC028

Time Frame: Throughout the study treatment and safety follow up period, up to 25 months

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

Secondary Outcomes

Mean maximum concentration of MGC028 antibody(Through Cycle 6 of the study, approximately 18 weeks)
Mean Area Under the Concentration Time Curve of MGC028 antibody(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)(Throughout the study and follow up period, up to 2.5 years.)
Median Duration of Response(Throughout the study and follow up period, up to 2.5 years.)
Mean maximum concentration of MGC028 free payload(Through Cycle 6 of the study, approximately 18 weeks)
Mean Area Under the Concentration Time Curve Total exposure of MGC028 payload(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.)