A Study of MGC030 in Participants With Advanced Solid Tumors

September 10, 2026 updated by: MacroGenics

A Phase 1, First-in-Human, Open Label, Dose Escalation, Dose Optimization, and Cohort Expansion Study of MGC030 in Participants With Advanced Solid Tumors

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

314

Phase

  • Phase 1

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants in dose escalation cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: urothelial cancer, colorectal cancer (CRC), gastric or gastroesophageal junction (GEJ) cancer, esophageal cancer, 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 histologically proven, unresectable, locally advanced or metastatic solid tumors

    • Urothelial cancer with progression following platinum-containing chemotherapy for metastatic or locally advanced/unresectable cancer, or within 12 months from completion of neo-adjuvant or adjuvant platinum-containing chemotherapy for localized muscle-invasive cancer.
    • Gastric/GEJ carcinoma with progression during or following at least 1 systemic therapy.
    • Esophageal cancer with progression during or following at least 1 systemic therapy.

    • CRC with progression during or following treatment with at least 2 prior lines of systemic therapy (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease.

      • CRC harboring an activating EGFR mutation must have progressed during or following at least one EGFR targeted therapy, if available.
      • Participants should have received no more than 4 prior lines of systemic therapy for advanced or metastatic disease.
    • Pancreatic cancer with progression during or following at least 1 systemic therapy. Participants should have received no more than 2 prior lines of cytotoxic chemotherapy 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.

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.
  • History of primary immunodeficiency.
  • Active viral, bacterial, or fungal infection
  • Prior treatment with Topoisomerase 1-based ADCs 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose escalation Cohort 1
MGC030 Dose Level 1
Biological: MGC030
Antibody-drug conjugate
Experimental: Dose escalation Cohort 2
MGC030 Dose Level 2
Biological: MGC030
Antibody-drug conjugate
Experimental: Dose escalation Cohort 3
MGC030 Dose Level 3
Biological: MGC030
Antibody-drug conjugate
Experimental: Dose escalation Cohort 4
MGC030 Dose Level 4
Biological: MGC030
Antibody-drug conjugate
Experimental: Dose escalation Cohort 5
MGC030 Dose Level 5
Biological: MGC030
Antibody-drug conjugate
Experimental: Dose escalation Cohort 6
MGC030 Dose Level 6
Biological: MGC030
Antibody-drug conjugate
Experimental: Dose Optimization Cohort 1
Dose Optimization Dose Level 1
Biological: MGC030
Antibody-drug conjugate
Experimental: Dose Optimization Cohort 2
Dose Optimization Dose Level 2
Biological: MGC030
Antibody-drug conjugate
Experimental: Expansion Cohort 1
Recommended dose for expansion
Biological: MGC030
Antibody-drug conjugate
Experimental: Expansion Cohort 2
Recommended dose for expansion
Biological: MGC030
Antibody-drug conjugate
Experimental: Expansion Cohort 3
Recommended dose for expansion
Biological: MGC030
Antibody-drug conjugate
Experimental: Expansion Cohort 4
Recommended dose for expansion
Biological: MGC030
Antibody-drug conjugate
Experimental: Expansion Cohort 5
Recommended dose for expansion
Biological: MGC030
Antibody-drug conjugate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to dose interruption, AEs leading to dose reduction or treatment discontinuation, does limiting toxicities and AEs of special interest.
Time Frame: Throughout the study, estimated duration 2 years.
Throughout the study, estimated duration 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean concentrations MGC030 antibody-drug conjugate, total antibody and unconjugated payload.
Time Frame: Throughout the study treatment period, up to 2 years
Throughout the study treatment period, up to 2 years
Number of Participants Who Develop Anti-Drug Antibodies to MGC030
Time Frame: Throughout the study treatment period, up to 2 years
Throughout the study treatment period, up to 2 years
Objective response rate
Time Frame: Throughout the study treatment period, up to 2 years
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 treatment period, up to 2 years
Duration of Response
Time Frame: Throughout the study treatment period, up to 2 years.
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 treatment period, up to 2 years.

Collaborators and Investigators

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

Sponsor

MacroGenics

Investigators

  • Study Director: Frank Perabo, MD, PhD, MacroGenics

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 Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-MGC030-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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