Clinical trial · Interventional
This is a Trial of MG1-E6E7 With Ad-E6E7 and Atezolizumab in Patients With HPV Associated Cancers
Phase 1/1b, Multicenter, Open-label Trial of Oncolytic MG1 Virus (MG1-E6E7) With Adenovirus Vaccine (Ad-E6E7) Both Expressing Mutant Human Papilloma Virus (HPV) E6 and E7 and Atezolizumab in Pts With HPV Assoc. Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Virus potency titer of drug product as determined by an improved potency assay was lower than originally determined by the assay described in the IND.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV-Associated Cancers | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ad-E6E7 | Biological | — | UNRESOLVED |
| Atezolizumab | Biological | Atezolizumab | ALIAS |
| MG1-E6E7 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 (Intravenous dosing)
- description
- 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.
- interventionNames
- Biological: Ad-E6E7
- Biological: MG1-E6E7
- Biological: Atezolizumab
- type
- EXPERIMENTAL
- label
- Arm 2 (Intravenous and Intra-tumoral injection dosing)
- description
- 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.
- interventionNames
- Biological: Ad-E6E7
- Biological: MG1-E6E7
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically or cytologically confirmed recurrent or metastatic HPV associated tumor (cervical, oropharyngeal, vulvar, vaginal, anal, or penile) with documented disease progression. * Arm 1, Phase 1 dose escalation: Cervical, HPV+ oropharyngeal, vulvar, vaginal, anal, or penile * Arm 1, Cohort A: Cervical cancer * Arm 1, Cohort B: HPV+ Oropharyngeal cancer * Arm 2 Phase 1 dose escalation and Cohort C: Cervical, oropharyngeal, vulvar, vaginal, anal, or penile * Failed, refused or intolerant to systemic therapy * Measurable disease based on RECIST 1.1 * At least one tumor mass amenable to core needle biopsy * Arm 2 only: At least one tumor judged as being safely injectable * ECOG performance status 0 or 1 * Demonstrate adequate organ function * Additional Inclusion criteria exist Key Exclusion Criteria: * Prior systemic therapy within 4 weeks. * Patients receiving prior XRT must have recovered from any acute toxicity. * Currently receiving/received experimental therapy within 4 weeks. * Prior treatment with any HPV vaccine therapy for cancer. * Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections. * Known active CNS metastases and/or carcinomatous meningitis. * Clinically significant tumor invasion/ rapidly accumulating ascites, pericardial or pleural effusions. * Active infection requiring systemic therapy. * Active autoimmune disease that has required systemic therapy in the past 2 years. * Conditions likely to have resulted in splenic dysfunction. * Known HIV/AIDS, active HBV or HCV infection. * Received prior treatment with vesicular stomatitis (VSV) viral vector. * Received immunosuppressive medication within 4 weeks. (\>10mg/day prednisone) * ≥ Grade 2 dyspnea and/or require supplemental oxygen * Known intolerance to anti-PD-1 or anti-PD-L1 antibody therapy * Additional Exclusion criteria exist Exclusion Criteria Household Contacts: * Patients with household contacts meeting any of the following criteria are ineligible for study entry unless alternate living arrangements can be made, while under contact precautions. * Women who are pregnant or nursing an infant * Children \< 1 year old * Individuals who are severely immunocompromised * Contact precautions are from initial treatment with MG1-E6E7 to 7 days after the last dose of MG1-E6E7
References
Publications (0)
Data not yet available