A Study of MGA012 in Patients with Advanced Solid Tumors

• Research type

  Research Study

• Full title

  A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of MGA012 in Patients with Advanced Solid Tumors

• IRAS ID

  229381

• Contact name

  Udai Banerji

• Contact email

  udai.banerji@icr.ac.uk

• Sponsor organisation

  MacroGenics, Inc.

• Eudract number

  2017-000865-63

• Clinicaltrials.gov Identifier

  NCT03059823

• Duration of Study in the UK

  3 years, 3 months, 19 days

• Research summary

  This study is a Phase 1, open label, dose-escalation study.
  “Open label” means that both patient and study doctor know what study medication is being administered. All patients in this study will receive the study medication MGA012.
  “Dose-escalation” means that the amount of MGA012 given in the study will be increased as more patients are enrolled. Patients will receive the next higher dose of MGA012 after confirming that the lower dose did not cause unacceptable side effects.
  In this study, MGA012 will be administered once every 2 weeks or once every 4 weeks. MGA012 is given intravenously (IV) in “cycles.” Each cycle is 4 weeks.
  The study consists of 2 phases, a Dose Escalation Phase followed by a Cohort Expansion Phase. The purpose of the dose-escalation phase is to find the highest dose of MGA012 that can be given without unacceptable side effects. In the cohort expansion phase, patients will be treated to see what effects MGA012 might have on them and the cancer at the highest dose considered to have manageable side effects. Patients with endometrial cancer, cervical cancer, sarcoma, and non-small cell lung cancer will participate in the cohort expansion phase. Patients in the cohort expansion phase will receive MGA012 once every 2 weeks.
  Periodically, patients will have a CT scan or an MRI to check the effect of the treatment on the cancer. For the first 24 weeks of treatment, these will occur every 8 weeks, after which they will occur every 12 weeks. If the cancer has not progressed or has gotten better, patients may receive additional cycles of treatment up to a total of 24 cycles (about 2 years). Thirty days after the last dose all patients will be followed for safety evaluation and for survival assessment every 6 months for up to 2 years.

  Lay Summary of Results

  A final summary of results was submitted to EudraCT in
  May 2025
  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: Results were posted to EudraCT in May 2025.
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: Data has been presented on poster presentations and on websites and also published in scientific journals.

  A final study report was developed at completion of data analysis.
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: No
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected:
  If no, explain why they haven't: The CSR will be provided to each clinical trial site and it can be made available to the patient upon their request.
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: Data has been presented on poster presentations and on websites and also published in scientific journals. A final study report was developed at completion of data analysis.
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: Yes
  If yes, describe or provide a URL: Data and samples have been shared as per dissemination plan.
  If no, explain why:
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• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  17/LO/1432

• Date of REC Opinion

  28 Sep 2017

• REC opinion

  Favourable Opinion