This is a Trial of MG1-E6E7 With Ad-E6E7 and Atezolizumab in Patients With HPV Associated Cancers

Conditions

• HPV-Associated Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ad-E6E7 — BIOLOGICAL
  Adenovirus vaccine expressing mutant HPV E6 and E7
• MG1-E6E7 — BIOLOGICAL
  MG1 Maraba oncolytic virus expressing mutant HPV E6 and E7
• Atezolizumab — BIOLOGICAL
  monoclonal antibody; checkpoint inhibitor

Study Details

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 Dates

Start date

Jun 21, 2018

Status verified

Apr 2023

Primary completion

Mar 5, 2021

Completion

Mar 5, 2021

Study Design

Enrollment

8 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1 (Intravenous dosing)
  Fixed dose of Ad-E6E7 administered IM on study Day 1. Followed by one of 3 dose levels (escalation) of MG1-E6E7 administered as 4 infusion (IV) doses over 2 weeks starting at study day 15. Fixed dose of atezolizumab administered IV every 3weeks starting at study day 43.
• Experimental: Arm 2 (Intravenous and Intra-tumoral injection dosing)
  Fixed dose of Ad-E6E7 administered IM on study Day 1. Followed by one of 2 dose levels (escalation) of MG1-E6E7 administered as 1 IV dose, starting at study day 15, followed by 2 intratumoral (IT) doses administered on study days 18 \& 29. Fixed dose of atezolizumab administered IV every 3weeks starting at study day 43.

Primary Outcome Measure

Safety of Ad/MG1-E6E7 administration in HPV associated cancers [ Time Frame: 8 months ]

Locations (5)

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