Recruiting
Phase 1

MGC028

Sponsor:

MacroGenics

Code:

NCT06723236

Conditions

Advanced Solid Tumors

NSCLC Adenocarcinoma

Cholangiocarcinoma

Pancreatic Carcinoma

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MGC028

Study Details

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.

Conditions

Advanced Solid Tumors

NSCLC Adenocarcinoma

Cholangiocarcinoma

Pancreatic Carcinoma

Colorectal Carcinoma

Study ID

NCT06723236

Start date

Feb 13, 2025

Status verified date

Apr, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

  • 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.

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.

Study Design

Enrollment

124 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Dose level 1 of MGC028, IV

experimental: Cohort 2

Dose level 2 of MGC028, IV

experimental: Cohort 3

Dose level 3 of MGC028, IV

experimental: Cohort 4

Dose level 4 of MGC028, IV

experimental: Cohort 5

Dose level 5 of MGC028, IV

experimental: Cohort 6

Dose level 6 of MGC028, IV

experimental: Expansion Cohort 1

MTD or MAD of MGC028, IV

experimental: Expansion Cohort 2

MTD or MAD of MGC028, IV

experimental: Expansion Cohort 3

MTD or MAD of MGC028, IV

Interventions

MGC028

MGC028 is an antibody-drug conjugate targeted against ADAM9.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Global Trial Manager

301-251-5172info@macrogenics.com

Locations

UCSF - Helen Diller Family Cancer Center

Recruiting

San Francisco, California, United States, 94115

Principal Investigator:

Pamela Munster

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Harshaband Singh

Dana Farber/Harvard Cancer Center

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Kimberly Perez

South Texas Accelerated Research Therapeutics (START) Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Principal Investigator:

Manish Sharma

Icahn School of Medicine at Mt. Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Deborah Doroshow

South Texas Accelerated Research Therapeutics (START) San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Drew Rasco

South Texas Accelerated Research Therapeutics (START) Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

Principal Investigator:

Justin Call

More Information

Sponsor

MacroGenics

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MacroGenics on 2026-04-27.