RECRUITING

A Study of MGC028 in Participants With Advanced Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-13
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06723236

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Participants in expansion cohorts must have either
  3. * NSCLC adenocarcinoma with
  4. * progression on or following anti-PD-1/PD-L1 inhibitor, unless contraindicated
  5. * progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present
  6. * no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease.
  7. * Pancreatic cancer
  8. * following at least 1 systemic therapy
  9. * no more than 2 prior lines of cytotoxic therapy for advanced or metastatic disease.
  10. * Colorectal adenocarcinoma with
  11. * Progression during or following standard therapy with a fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan unless contraindicated, refused or unavailable
  12. * Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI- H/dMMR, if present.
  13. * No more that 2 lines of cytotoxic chemotherapy for advanced or metastatic disease
  14. * No more than 4 lines of systemic regimens for advanced or metastatic disease
  15. * Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
  16. * 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.
  17. * Participants have acceptable physical condition and laboratory values.
  18. * Participants of childbearing potential must agree to use highly effective methods of birth control.
  19. * Participants must not be pregnant, planning to be pregnant, or breastfeeding.
  1. * Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
  2. * Active brain metastases or leptomeningeal metastases.
  3. * Prior stem cell, tissue, or solid organ transplant.
  4. * 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.
  5. * Active viral, bacterial, or fungal infection
  6. * Prior treatment with ADAM9 targeted agent for cancer.
  7. * 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.

Contacts and Locations

Study Contact

Global Trial Manager
CONTACT
301-251-5172
info@macrogenics.com

Principal Investigator

Pepi Pencheva, M.D.
STUDY_DIRECTOR
MacroGenics

Study Locations (Sites)

UCSF - Helen Diller Family Cancer Center
San Francisco, California, 94115
United States
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, 02115
United States
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, 49546
United States
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
United States
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, 78229
United States
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah, 84119
United States

Collaborators and Investigators

Sponsor: MacroGenics

  • Pepi Pencheva, M.D., STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2025-02-13
Study Completion Date2027-04

Study Record Updates

Study Start Date2025-02-13
Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumors
  • NSCLC Adenocarcinoma
  • Cholangiocarcinoma
  • Pancreatic Carcinoma
  • Colorectal Carcinoma