A Study of MGC026 in Participants With Advanced Solid Tumors

Last updated: August 11, 2025
Sponsor: MacroGenics
Overall Status: Active - Recruiting

Phase

1

Condition

Endometrial Cancer

Cancer/tumors

Pancreatic Cancer

Treatment

MGC026 Dose for Expansion

MGC026 Dose Escalation

Clinical Study ID

NCT06242470
CP-MGC026-01
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults ≥ 18 years old, able to provide informed consent

  • Adequate performance and laboratory parameters

  • Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample.Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if anarchival tumor sample is not available. Participants with no available archivaltissue sample who cannot safely undergo a fresh biopsy as determined by consultationbetween the sponsor and investigator are eligible

  • Unresectable, locally advanced or metastatic solid tumors including: squamous cellcancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamousnon-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 gastroesophagealcancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.

  • Measurable disease per RECIST v1.1. Participants with metastatic CRPC withoutmeasurable disease are eligible.

  • Must be willing to use highly effective methods of birth control from the time ofconsent through 7 months after discontinuation of MGC026.

  • Not pregnant or breastfeeding.

Exclusion

Exclusion Criteria:

  • Any underlying medical or psychiatric condition impairing participant's ability toreceive, tolerate, or comply with the planned treatment or study procedures.

  • Another cancer that required treatment within the past 2 years, with the exceptionof those with low risk of cancer spreading or death such as adequately treated nonmelanomatous skin cancer, localized prostate cancer (Gleason Score < 6), orcarcinoma in situ.

  • Patients with history of prior central nervous system (CNS) metastasis must havebeen treated, be asymptomatic, and not have concurrent treatment for CNS disease,progression of CNS metastases on magnetic resonance imaging, computed tomography orpositron emission tomography, or history of leptomeningeal disease or cordcompression at the time of enrollment.

  • Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigenreceptor-T therapy, or anti-hormonal within protocol specified intervals.

  • Prior treatment with any B7-H3 targeted agent for cancer or any ADC with atopoisomerase payload.

  • Prior autologous or allogeneic stem cell or solid organ transplant.

  • Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.

  • Active viral, bacterial, or systemic fungal infection requiring parenteral treatmentwithin 1 week of first study drug administration.

  • Known history of hepatitis B or C infection or known positive test for hepatitis Bsurface antigen or core antigen, or hepatitis C polymerase chain reaction.

  • Known positive testing for human immunodeficiency virus or history of acquiredimmune deficiency syndrome.

  • History of primary immunodeficiency.

  • Major trauma or major surgery within 4 weeks of first study drug administration.

  • Known hypersensitivity to recombinant proteins.

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: MGC026 Dose for Expansion
Phase: 1
Study Start date:
March 06, 2024
Estimated Completion Date:
October 31, 2028

Connect with a study center

  • ICON Cancer Centre Wesley

    Auchenflower, Queensland 4066
    Australia

    Active - Recruiting

  • ICON Cancer Centre Kurralta Park

    Kurralta Park, South Australia 5037
    Australia

    Active - Recruiting

  • Austin Health- Olivia Newton John Cancer Center

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU
    United Kingdom

    Active - Recruiting

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • The Angeles Clinic and Research Institute

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Providence Cancer Institute

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • START Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

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