314 Participants NeededMy employer runs this trial

MGC030 for Cancer

GT
Overseen ByGlobal Trial Manager
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: MacroGenics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

FP

Frank Perabo, MD, PhD

Principal Investigator

MacroGenics

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors (like bladder, colorectal, stomach, esophageal, or pancreatic cancer) that have not responded to standard treatments or when no other options exist. Participants must have measurable disease and limited prior therapies.

Inclusion Criteria

Participants must not be pregnant, planning pregnancy, or breastfeeding
My stomach or GEJ cancer got worse after at least one treatment.
Participants of childbearing potential must agree to use highly effective birth control methods
See 12 more

Exclusion Criteria

Any underlying medical or psychiatric condition impairing ability to receive, tolerate, or comply with treatment or study procedures
I have cancer that has spread to my brain or spinal fluid.
I have been treated with Topoisomerase 1-based ADCs for my cancer.
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • MGC030

Trial Overview

The study tests a new drug called MGC030 given every 3 weeks to see if it is safe and can help control tumor growth in people with certain advanced cancers. Researchers will monitor side effects and how well the cancer responds.

How Is the Trial Designed?

13

Treatment groups

Experimental Treatment

Group I: Expansion Cohort 5Experimental Treatment1 Intervention
Group II: Expansion Cohort 4Experimental Treatment1 Intervention
Group III: Expansion Cohort 3Experimental Treatment1 Intervention
Group IV: Expansion Cohort 2Experimental Treatment1 Intervention
Group V: Expansion Cohort 1Experimental Treatment1 Intervention
Group VI: Dose escalation Cohort 6Experimental Treatment1 Intervention
Group VII: Dose escalation Cohort 5Experimental Treatment1 Intervention
Group VIII: Dose escalation Cohort 4Experimental Treatment1 Intervention
Group IX: Dose escalation Cohort 3Experimental Treatment1 Intervention
Group X: Dose escalation Cohort 2Experimental Treatment1 Intervention
Group XI: Dose escalation Cohort 1Experimental Treatment1 Intervention
Group XII: Dose Optimization Cohort 2Experimental Treatment1 Intervention
Group XIII: Dose Optimization Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MacroGenics

Lead Sponsor

Trials
51
Recruited
5,400+