A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
NCT ID: NCT04370587
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2020-09-17
2027-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1
T3011 single agent dose escalation in participants with solid tumors
T3011
T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
Phase 2a Part 1 Arm A
RP2D T3011 single agent in participants with melanoma
T3011
T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
Phase 2a Part 1 Arm B
RP2D T3011 single agent in participants with other solid tumors
T3011
T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
Phase 2a Part 2 Arm C
RP2D T3011 + pembrolizumab in participants with NSCLC
T3011 + pembrolizumab
T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.
Rollover Arm
RP2D T3011 + pembrolizumab in participants who have progressed on T3011 single agent
T3011 + pembrolizumab
T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.
Interventions
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T3011
T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
T3011 + pembrolizumab
T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.
Eligibility Criteria
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Inclusion Criteria
2. Disease progression after standard of care (SOC) therapy or in the opinion of
3. The Investigator unlikely to benefit from SOC therapy. Inclusion Diagnosis Phase 1 - Histologically or pathologically confirmed locally recurrent or metastatic advanced malignancy.
Phase 2a Part 1 i. Arm A - locally recurrent or metastatic melanoma. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.
ii. Arm B - locally recurrent or metastatic HNSCC. It must also meet the following criteria: 1) Disease progression to platinum-containing chemotherapy; 2) Failure to anti-PD-1/PDL1 blockade after receiving at least 2 doses alone or in combination.
iii. Arm C - Sarcoma. Participants must have received no more than three lines of prior anti-cancer therapies.
iv. Arm D - locally recurrent or metastatic cSCC. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.
Phase 2a Part 2 i.v. Arm E - Histologically or pathologically confirmed NSCLC that is advanced or recurrent, without EGFR mutation or ALK rearrangement. Participants must have received at least one line but no more than three lines of prior anti-cancer therapies.
4. Measurable disease per RECIST version 1.1.
5. Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
7. Life expectancy \> 12 weeks.
8. Demonstrate adequate organ function as defined by acceptable laboratory testing results.
9. Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T3011. WCBP must have a negative serum pregnancy test prior to W1D1.
10. Last dose of previous anticancer therapy ≥ 21 days, radiotherapy \> 21 days, or surgical intervention \> 21 days prior to the first dose of T3011.
11. Recovered from all prior anticancer therapy toxicities.
12. Willingness to provide fresh tumor biopsy specimens as specified in the Schedule of Assessments.
13. Capable of understanding and complying with protocol requirements.
14. Signed and dated institutional review board/independent ethics committee-approved informed consent form before any protocol-directed screening procedures are performed.
Exclusion Criteria
2. Patients with injectable tumors impinging upon major airways or blood vessels.
3. HNSCC only: Prior re-irradiation field containing carotid artery.
4. Greater than 3 distant metastatic lymph node regions and/or metastatic lesions or the largest distant metastases with a diameter of more than 3 cm (non-sarcoma)/5 cm (sarcoma) unless the lesion is to be injected.
5. Prior treatment with another OV (including T-VEC), tumor vaccines, cellular therapy or gene therapy.
6. Prior intolerance to anti-PD-(L)1 monoclonal antibody or history of immunotherapy related non-infectious pneumonitis/interstitial lung disease.
7. Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.
8. Requires continued concurrent therapy with any drug active against HSV.
9. Live vaccines, attenuated vaccines within 4 weeks prior to initiation of study treatment (participants vaccinated with inactivated vaccines can be enrolled.
10. Primary or acquired immunodeficient states.
11. Pregnant or lactating.
12. Prior organ transplantation.
13. Active hepatitis B virus, hepatitis C virus, and HIV infection or a positive serological test at Screening within 14 days of dosing with T3011.
14. Active autoimmune disease or medical conditions requiring chronic steroid or immunosuppressive therapy within 4 weeks prior to first administration of study treatment.
15. History of or current central nervous system metastases.
16. History of seizure disorders within 6 months of Screening.
17. Active oral or skin herpes lesion at Screening.
18. Active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids.
19. Congestive heart failure, active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina, or clinically significant cardiac arrhythmias.
20. History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody.
18\. Active infection with SARS-CoV-2 virus. 21. Participants with moderate to large amount of pleural effusion, ascites or pericardial effusion who need drug or medical intervention.
22\. Other systemic conditions or organ abnormalities that, in the opinion of the investigator, may interfere with the conduct and/or interpretation of the current study.
18 Years
ALL
No
Sponsors
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ImmVira Pharma Co. Ltd
INDUSTRY
Responsible Party
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Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Southern Oncology
Bedford Park, , Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, , Australia
The Alfred
Melbourne, , Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTIV1708
Identifier Type: -
Identifier Source: org_study_id
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