This is a Trial of MG1-E6E7 With Ad-E6E7 and Atezolizumab in Patients With HPV Associated Cancers
Stopped early · Phase 1
Conditions studied: HPV-Associated Cancers
In brief
This is a Phase 1/1b open-label dose escalation trial of Ad/MG1-E6E7 and sequential treatment with atezolizumab in patients with HPV associated cancers. This study will consist of two arms. Both arms will dose escalate (MG1-E6E7) using a 3 + 3 design in Phase 1 to establish initial safety and the maximum tolerated dose (MTD) / maximum feasible dose (MFD). * Arm 1 - intravenous (IV) administration of MG1-E6E7 following intramuscular (IM) AD-E6E7 priming and subsequent treatment with IV atezolizumab. * Arm 2 - intratumoral (IT) and IV injection of MG1-E6E7 following (IM) Ad-E6E7 priming and subsequent treatment with IV atezolizumab. In the Phase 1b expansion for each arm, additional patients will be enrolled at the MTD as determined in Phase 1 in order to more thoroughly explore immune response, pharmacokinetics/dynamics, and safety for the patient populations with Cervical cancer, HPV positive (HPV+) Oropharyngeal cancer (Phase 1B, Arm 1, Cohorts A and B respectively) and HPV+ tumors with injectable lesions (Phase 1B, Arm 2, Cohort 3).
Key facts
- Study ID
- NCT03618953
- Run by
- Turnstone Biologics, Corp.
- People needed
- 8
- Starts
- 2018-06-21
- Expected to finish
- 2021-03-05
- Last updated by the study team
- 2023-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Miami — Miami, Florida, United States
- Billings Clinic — Billings, Montana, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- University of Toledo-The Eleanor N. Dana Cancer Center — Toledo, Ohio, United States
- University of Texas-MD Anderson Cancer Center — Houston, Texas, United States
- Juravinski Cancer Centre — Hamilton, Ontario, Canada
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada
- Princess Margaret Hospital — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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