MGC028 for Solid Tumors

Recruiting at 5 trial locations

Overseen By Global Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MacroGenics

Disqualifiers: Active brain metastases, Prior transplant, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of the new drug MGC028 for individuals with certain advanced solid tumors that cannot be surgically removed. The primary focus is to determine if MGC028 can shrink or control these tumors and identify any potential side effects. Participants will receive the drug through an IV every three weeks and undergo regular health checks. This trial suits those with specific cancers, such as lung or colorectal, who have not responded to other treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you should discuss all your medications with the study doctor, as they will assess any potential interactions or necessary adjustments.

Is there any evidence suggesting that MGC028 is likely to be safe for humans?

Research has shown that MGC028 has promising safety results from preclinical lab studies. In these studies, animals with solid tumors tolerated MGC028 well, experiencing no severe side effects. This suggests the treatment might also be safe for humans.

This trial is in an early phase, focusing on the safety of MGC028 in humans. Early phase trials aim to test the safety of a new treatment and determine the best dose that people can take without serious side effects. While some side effects might occur, the trial will help doctors understand and manage them better. Study doctors will closely monitor participants and treat any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MGC028 for solid tumors because it represents a new approach to cancer treatment. Unlike traditional chemotherapies that indiscriminately attack both cancerous and healthy cells, MGC028 is an antibody-drug conjugate designed to specifically target and deliver its cytotoxic payload directly to cancer cells, minimizing damage to normal tissues. This targeted delivery not only has the potential to be more effective but also aims to reduce the side effects typically associated with conventional cancer treatments. This innovative mechanism could provide a significant advancement over current standard care options, which often rely on broad-spectrum chemotherapy or radiation therapy.

What evidence suggests that MGC028 might be an effective treatment for solid tumors?

Research has shown that MGC028 could help treat solid tumors. Early lab studies demonstrated MGC028's effectiveness against various solid cancers. It targets a protein called ADAM9, often present in high amounts in certain tumors, allowing MGC028 to attack cancer cells more directly. Initial tests indicated that MGC028 was generally well tolerated, as it did not cause serious side effects in those studies. While these results are promising, this trial will test different dose levels of MGC028 in humans to confirm its effectiveness and safety. ^{1 3 5 6 7}

Who Is on the Research Team?

Pepi Pencheva, M.D.

Principal Investigator

MacroGenics

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that can't be removed by surgery, like certain types of lung, bile duct, and pancreatic cancers. They must have tried standard treatments without success or couldn't tolerate them. Participants need at least one measurable tumor and should not have had more than two prior chemotherapy treatments for their advanced disease.

Inclusion Criteria

I have NSCLC or pancreatic cancer with limited prior treatments.

My health and lab results meet the study's requirements.

My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.

Exclusion Criteria

I do not have any ongoing infections.

I have had a stem cell, tissue, or organ transplant in the past.

I haven't had treatment for another cancer, except for certain low-risk types, in the past 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive study treatments every 3 weeks, with assessments of tumor status and monitoring for side effects

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 25 months

Expansion Cohort

Participants receive the maximum tolerated dose or maximum administered dose of MGC028

Variable

What Are the Treatments Tested in This Trial?

Interventions

• MGC028

Trial Overview The trial is testing MGC028 to see if it's safe and what the highest dose patients can take without serious side effects is. It also looks at whether MGC028 can shrink tumors or control cancer progression in those with specific advanced solid tumors expressing ADAM9.

How Is the Trial Designed?

Group I: Expansion Cohort 3 Experimental Treatment 1 Intervention

MTD or MAD of MGC028, IV

Group II: Expansion Cohort 2 Experimental Treatment 1 Intervention

MTD or MAD of MGC028, IV

Group III: Expansion Cohort 1 Experimental Treatment 1 Intervention

MTD or MAD of MGC028, IV

Group IV: Cohort 6 Experimental Treatment 1 Intervention

Dose level 6 of MGC028, IV

Group V: Cohort 5 Experimental Treatment 1 Intervention

Dose level 5 of MGC028, IV

Group VI: Cohort 4 Experimental Treatment 1 Intervention

Dose level 4 of MGC028, IV

Group VII: Cohort 3 Experimental Treatment 1 Intervention

Dose level 3 of MGC028, IV

Group VIII: Cohort 2 Experimental Treatment 1 Intervention

Dose level 2 of MGC028, IV

Group IX: Cohort 1 Experimental Treatment 1 Intervention

Dose level 1 of MGC028, IV

Who Is Running the Clinical Trial?

MacroGenics

Lead Sponsor

Trials

51

Recruited

5,400+

Published Research Related to This Trial

In a study involving 15 patients with advanced non-small cell lung cancer (NSCLC) who had previously undergone chemotherapy, the novel antitumor agent MGI-114 showed no objective tumor responses, leading to the conclusion that it is not effective as a second-line treatment.

The treatment was associated with significant side effects, including grade 2 or higher thrombocytopenia in 40% of patients, and grade 3 nausea and grade 2 vomiting in 40% and 47% of patients, respectively, indicating safety concerns with this dosing regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II trial of 6-hydroxymethylacylfulvene (MGI-114, irofulven) in patients with advanced non-small cell cancer previously treated with chemotherapy. Dowell, JE., Johnson, DH., Rogers, JS., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06723236

NCT06723236 | A Study of MGC028 in Participants With ... The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum ...

2. aacrjournals.org aacrjournals.org/cancerres/article/84/6_Supplement/1897/736331/Abstract-1897-Preclinical-development-of-MGC028-an

Preclinical development of MGC028, an ADAM9-targeted ... Conclusions: MGC028 exhibited potent antitumor activity in in vivo models representing various solid cancer indications and was well ...

3. macrogenics.com macrogenics.com/wp-content/uploads/2024/12/AACR-2024-Poster-Preclinical-Development-of-MGC028-ADAM9-ADC.pdf

ADAM9 MGC028 Conclusions: MGC028 exhibited potent antitumor activity in in vivo models representing various solid cancer indications and was well tolerated in non-human ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/558195

A Study of MGC028 in Participants With Advanced Solid ... The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose ...

5. withpower.com withpower.com/trial/mgc028-for-solid-tumors-49f66

MGC028 for Solid Tumors The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41166694/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1DM1CloEoPKIQyZLESyg8hFN6EhOyk77DKixqBpj6QP1LwVgZS&fc=None&ff=20251030222424&v=2.18.0.post22+67771e2

Preclinical development of MGC028, an ADAM9-targeted ... A first-in-human study of MGC028 in patients with advanced solid tumors has been initiated (NCT06723236). Associated data. ClinicalTrials.gov ...

7. ir.macrogenics.com ir.macrogenics.com/news-releases/news-release-details/macrogenics-provides-update-corporate-progress-and-first-7

Press Release The Phase 1 study of MGC028 in patients with advanced solid tumors is ongoing. MGC030 is a preclinical ADC that targets an undisclosed ...