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Taking people in United KingdomPhase 1

Tests MGC026 in people with advanced solid tumors

Tests MGC026, with or without pembrolizumab, in adults with advanced solid tumors.

Key facts

Who runs it
MacroGenics
Where
Oxford and Sutton, United KingdomSee the 2 sitesAlso in 2 other countries, 10 sites
Trial code
Registry title
A Study of MGC026 in Participants With Advanced Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
394 people, planned
Started
6 Mar 2024
Expected to end
Apr 2029
Type of study
Interventional, 16 groups
Treatments tested
  • MGC026 Dose Escalation
  • MGC026 Dose for Expansion
  • Pembrollizumab
  • vobramitamab tavatecan
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumors that cannot be removed by surgery or have spread, and that can be measured on scans.

Age
18 years or older
Sex
All sexes can join
Disease stage
Unresectable, locally advanced or metastatic solid tumors, such as head and neck squamous cell cancer, lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, prostate, breast, ovarian, colorectal and other cancers. The disease must be measurable on scans, except in metastatic castration resistant prostate cancer.
Earlier treatment
Cannot have had a B7-H3 targeted drug or an antibody-drug conjugate with a topoisomerase payload. Recent surgery or cancer treatment within the study's set time limits is not allowed.
Biomarker or test result
A tumor tissue sample is needed, either an archival sample or a fresh biopsy.

Main reasons for not taking part

  • Pregnant or breastfeeding
  • Another cancer treated within the past 2 years, with some exceptions
  • Untreated or active brain metastases
  • Past stem cell or solid organ transplant
  • Known hepatitis B or C, HIV, or primary immunodeficiency

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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 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

Who cannot take part

  • 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
  • Major trauma or major surgery within 4 weeks of first study drug administration
  • Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures
  • 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
  • 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
  • Known hypersensitivity to recombinant proteins

Where in United Kingdom

Also in 2 other countries, 10 sites

  • Oxford University Hospitals NHS Foundation TrustOxford, United KingdomContact: Global Trial ManagerTaking people
  • The Royal Marsden NHS Foundation TrustSutton, United KingdomContact: Global Trial ManagerTaking people

About the trial

What the trial wants to find out

The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of vobramitamab tavatecan (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 in Module A of the study. Combination therapy with pembrolizumab will occur in Module B of the study Participants will receive vobramitamab tavatecan by intravenous (IV) infusion. The dose of vobramitamab tavatecan will be assigned at the time of enrollment. Pembrolizumab will be administered at 200 mg every 3 weeks. 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 and tumor samples collected for research purposes.

The 16 groups in the trial

  • Module A Cohort 1Treatment being tested

    MGC026 is a topoisomerase 1 inhibitor (TOP1i)-based ADC that targets B7-H3 administered IV every 3 weeks.

    Treatment: MGC026 Dose Escalation

  • Module A Cohort 2Treatment being tested

    Treatment: MGC026 Dose Escalation

  • Module A Cohort 3Treatment being tested

    Treatment: MGC026 Dose Escalation

  • Module A Cohort 4Treatment being tested

    Treatment: MGC026 Dose Escalation

  • Module A Cohort 5Treatment being tested

    Treatment: MGC026 Dose Escalation

  • Module A Cohort 6Treatment being tested

    Treatment: MGC026 Dose Escalation

  • Module A Expansion cohort 1Treatment being tested

    Treatment: MGC026 Dose for Expansion

  • Module A Expansion cohort 2Treatment being tested

    Treatment: MGC026 Dose for Expansion

  • Module A Expansion cohort 3Treatment being tested

    Treatment: MGC026 Dose for Expansion

  • Module A Expansion cohort 4Treatment being tested

    Treatment: MGC026 Dose for Expansion

  • Module A Expansion Cohort 5Treatment being tested

    Treatment: MGC026 Dose for Expansion

  • Module A Expansion Cohort 6Treatment being tested

    Treatment: MGC026 Dose for Expansion

  • Module A Expansion Cohort 7Treatment being tested

    Treatment: MGC026 Dose for Expansion

  • Module A Expansion Cohort 8Treatment being tested

    Treatment: MGC026 Dose for Expansion

  • Module B Part 1, Dose Level 1Treatment being tested

    Treatment: Pembrollizumab and vobramitamab tavatecan

  • Module B Part 1, Dose Level 2Treatment being tested

    Module B Part 2, Dose Expansion

    Treatment: MGC026 Dose for Expansion and Pembrollizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests MGC026 in people with advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 October 2026