A Study of MGC026 in Participants With Advanced Solid Tumors
NCT ID: NCT06242470
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
250 participants
INTERVENTIONAL
2024-03-06
2028-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
MGC026 is a topoisomerase 1 inhibitor (TOP1i)-based ADC that targets B7-H3 administered IV every 3 weeks.
MGC026 Dose Escalation
Escalating doses of MGC026
Cohort 2
MGC026 Dose Escalation
Escalating doses of MGC026
Cohort 3
MGC026 Dose Escalation
Escalating doses of MGC026
Cohort 4
MGC026 Dose Escalation
Escalating doses of MGC026
Cohort 5
MGC026 Dose Escalation
Escalating doses of MGC026
Cohort 6
MGC026 Dose Escalation
Escalating doses of MGC026
Expansion cohort 1
MGC026 Dose for Expansion
MGC026 recommended dose for expansion
Expansion cohort 2
MGC026 Dose for Expansion
MGC026 recommended dose for expansion
Expansion cohort 3
MGC026 Dose for Expansion
MGC026 recommended dose for expansion
Expansion cohort 4
MGC026 Dose for Expansion
MGC026 recommended dose for expansion
Expansion Cohort 5
MGC026 Dose for Expansion
MGC026 recommended dose for expansion
Expansion Cohort 6
MGC026 Dose for Expansion
MGC026 recommended dose for expansion
Interventions
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MGC026 Dose Escalation
Escalating doses of MGC026
MGC026 Dose for Expansion
MGC026 recommended dose for expansion
Eligibility Criteria
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Inclusion Criteria
* 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 an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible
* 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.
* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.
* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.
* Not pregnant or breastfeeding.
Exclusion Criteria
* 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.
* 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.
* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.
* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase 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 treatment within 1 week of first study drug administration.
* 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.
* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
* History of primary immunodeficiency.
* Major trauma or major surgery within 4 weeks of first study drug administration.
* Known hypersensitivity to recombinant proteins.
18 Years
ALL
No
Sponsors
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MacroGenics
INDUSTRY
Responsible Party
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Principal Investigators
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Denise Casey, MD
Role: STUDY_DIRECTOR
MacroGenics
Locations
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The Angeles Clinic and Research Institute
Los Angeles, California, United States
START Midwest
Grand Rapids, Michigan, United States
START-New York Long Island
Lake Success, New York, United States
Providence Cancer Institute
Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
START Mountain Region
West Valley City, Utah, United States
ICON Cancer Centre Wesley
Auchenflower, Queensland, Australia
ICON Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia
Austin Health- Olivia Newton John Cancer Center
Heidelberg, Victoria, Australia
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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CP-MGC026-01
Identifier Type: -
Identifier Source: org_study_id
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