RECRUITING

A Study of MGC026 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 study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.

Official Title

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

Quick Facts

Study Start:2024-03-06
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06242470

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. * Adults ≥ 18 years old, able to provide informed consent
  2. * Adequate performance and laboratory parameters
  3. * Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.
  4. * Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.
  5. * Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.
  6. * Not 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. * Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \< 6), or carcinoma in situ.
  3. * Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.
  4. * Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.
  5. * Prior autologous or allogeneic stem cell or solid organ transplant.
  6. * Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.
  7. * Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.
  8. * Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.
  9. * Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
  10. * History of primary immunodeficiency.
  11. * Major trauma or major surgery within 4 weeks of first study drug administration.
  12. * Known hypersensitivity to recombinant proteins.

Contacts and Locations

Study Contact

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

Principal Investigator

Denise Casey, MD
STUDY_DIRECTOR
MacroGenics

Study Locations (Sites)

The Angeles Clinic and Research Institute
Los Angeles, California, 90025
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
Providence Cancer Institute
Portland, Oregon, 97213
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
START Mountain Region
West Valley City, Utah, 84119
United States

Collaborators and Investigators

Sponsor: MacroGenics

  • Denise Casey, MD, 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 Date2024-03-06
Study Completion Date2028-10

Study Record Updates

Study Start Date2024-03-06
Study Completion Date2028-10

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • Advanced Cancer
  • Metastatic Cancer
  • Squamous Cell Carcinoma of Head and Neck
  • Non Small Cell Lung Cancer
  • Small-cell Lung Cancer
  • Bladder Cancer
  • Sarcoma
  • Endometrial Cancer
  • Melanoma
  • Castration Resistant Prostatic Cancer
  • Cervical Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Gastro-esophageal Cancer
  • Pancreas Cancer
  • Clear Cell Renal Cell Carcinoma
  • Hepatocellular Carcinoma
  • Platinum-resistant Ovarian Cancer