Solid TumorPhase 1/2NCT04370587
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
A Phase 1/2 study testing T3011 and T3011 + pembrolizumab in people with Solid Tumor and Melanoma, run by ImmVira Pharma Co. Ltd at 9 sites in 2 countries.
Trial summary
This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Melanoma, HNSCC
- What is being tested?
- T3011 and T3011 + pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 17 Sep 2020to 10 Jan 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Disease progression after standard of care (SOC) therapy or in the opinion of
- 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.
- 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.
- Arm C - Sarcoma. Participants must have received no more than three lines of prior anti-cancer therapies.
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- 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.
- Measurable disease per RECIST version 1.1.
- Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy > 12 weeks.
- Demonstrate adequate organ function as defined by acceptable laboratory testing results.
- 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.
- Last dose of previous anticancer therapy ≥ 21 days, radiotherapy > 21 days, or surgical intervention > 21 days prior to the first dose of T3011.
- Recovered from all prior anticancer therapy toxicities.
- Willingness to provide fresh tumor biopsy specimens as specified in the Schedule of Assessments.
- Capable of understanding and complying with protocol requirements.
- Signed and dated institutional review board/independent ethics committee-approved informed consent form before any protocol-directed screening procedures are performed.
Who cannot join
- Have only uninjectable tumors..
- Patients with injectable tumors impinging upon major airways or blood vessels.
- HNSCC only: Prior re-irradiation field containing carotid artery.
- 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.
- Prior treatment with another OV (including T-VEC), tumor vaccines, cellular therapy or gene therapy.
- Prior intolerance to anti-PD-(L)1 monoclonal antibody or history of immunotherapy related non-infectious pneumonitis/interstitial lung disease.
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- Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.
- Requires continued concurrent therapy with any drug active against HSV.
- Live vaccines, attenuated vaccines within 4 weeks prior to initiation of study treatment (participants vaccinated with inactivated vaccines can be enrolled.
- Primary or acquired immunodeficient states.
- Pregnant or lactating.
- Prior organ transplantation.
- Active hepatitis B virus, hepatitis C virus, and HIV infection or a positive serological test at Screening within 14 days of dosing with T3011.
- Active autoimmune disease or medical conditions requiring chronic steroid or immunosuppressive therapy within 4 weeks prior to first administration of study treatment.
- History of or current central nervous system metastases.
- History of seizure disorders within 6 months of Screening.
- Active oral or skin herpes lesion at Screening.
- Active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids.
- Congestive heart failure, active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina, or clinically significant cardiac arrhythmias.
- 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.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States6 sites, 5 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Howard Kaufman, MD, clinicaltrials@immviragroup.com
Howard Kaufman, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Elizabeth Buchbinder, MD, clinicaltrials@immviragroup.com
Elizabeth Buchbinder, MD
- Recruiting
Mary Crowley Cancer Research
Dallas, Texas, 75230
Minal Barve, MD, clinicaltrials@immviragroup.com
Minal Barve, MD
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Alexander Spira, MD, clinicaltrials@immviragroup.com
- Completed
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
John Kirkwood, MD, clinicaltrials@immviragroup.com
John Kirkwood, MD
Australia3 sites, 3 recruiting
- Recruiting
Southern Oncology
Bedford Park
Ganessan Kichenadasse, clinicaltrials@immviragroup.com
Ganessan Kichenadasse
- Recruiting
Peninsula & South Eastern Haematology and Oncology Group
Frankston
Vinod Ganju, clinicaltrials@immviragroup.com
Vinod Ganju
- Recruiting
The Alfred
Melbourne
Andrew Haydon, clinicaltrials@immviragroup.com
Andrew Haydon
About this study
Official title: A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors
This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.
Read the detailed description
This is a Phase 1/2a, open-label, first-in-human study of T3011 given via intratumoral (IT) injection as a single agent and in combination with IV pembrolizumab in participants with advanced or metastatic solid tumors. The Phase 1 portion of the study is a single agent dose escalation which will use a 3+3 design to evaluate escalating doses of T3011. Total enrollment will depend on the toxicities and/or activity observed, with approximately 15 to 30 evaluable participants enrolled. Once the RP2D is established Phase 2a Part 1 will enroll approximately 10 participants with locally recurrent or metastatic melanoma (in Arm A) 23 to 53 participants with HNSCC in Arm B, 40 to 80 participants with sarcoma in Arm C and 10 participants with cSCC in Arm D. During Phase 2a Part 1 the safety, tolerability, and preliminary efficacy of T3011 as a single agent will be evaluated. Phase 2a Part 2 will enroll in parallel to Phase 2a Part 1 once the RP2D is established. The safety, tolerability, and preliminary efficacy of IT T3011 given in combination with IV pembrolizumab will be evaluated in 15 participants with histologically or pathologically confirmed metastatic NSCLC (Arm E). A rollover arm is also included in this study to allow participants who have documented progression on T3011 alone to receive T3011 in combination with pembrolizumab if considered eligible.
- Conditions
- Solid Tumor, Melanoma, HNSCC, Sarcoma, Squamous Cell Carcinoma, NSCLC
- Being tested
- T3011, T3011 + pembrolizumab
- Medical subject headings
- Melanoma, Squamous Cell Carcinoma of Head and Neck, Sarcoma, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3011Biological
T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
T3011 + pembrolizumabCombination product
T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | T3011 single agent dose escalation in participants with solid tumors Receives: Biological: T3011 |
| Phase 2a Part 1 Arm A | Experimental | RP2D T3011 single agent in participants with melanoma Receives: Biological: T3011 |
| Phase 2a Part 1 Arm B | Experimental | RP2D T3011 single agent in participants with other solid tumors Receives: Biological: T3011 |
| Phase 2a Part 2 Arm C | Experimental | RP2D T3011 + pembrolizumab in participants with NSCLC Receives: Combination Product: T3011 + pembrolizumab |
| Rollover Arm | Experimental | RP2D T3011 + pembrolizumab in participants who have progressed on T3011 single agent Receives: Combination Product: T3011 + pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of escalating doses T3011
Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Measured: Up to 2 years from first dose of T3011
To determine the dose(s) of T3011 to be examined in Phase 2a
Incidence of DLTs
Measured: Through the first two T3011 injections (approximately 28 days)
Safety and tolerability of T3011 dose(s) selected from Phase 1 in disease specific cohorts
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Measured: Up to 2 years from first dose of T3011
Characterize the safety and tolerability of T3011 in combination with pembrolizumab
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Measured: Up to 2 years from first dose of T3011
Characterize the safety and tolerability of T3011 in combination with pembrolizumab in participants who progress on T3011 alone
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Measured: Up to 2 years from first dose of T3011
Secondary outcomes (8)
Overall response rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1 and iRECIST.
Measured: Up to 2 years from first dose of T3011
Disease control rate (DCR)
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1 and iRECIST.
Measured: Up to 2 years from first dose of T3011
Duration of response (DOR)
DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.
Measured: Up to 2 years from first dose of T3011
Durable response (DR)
DR is defined as objective response (CR or PR) according to RECIST v1.1 and iRECIST.
Measured: Up to 2 years from first dose of T3011
Progression-free survival (PFS)
PFS is defined as the time from enrollment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST v1.1 and iRECIST.
Measured: Up to 2 years from first dose of T3011
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Measured: Up to 1 year after last dose of T3011
Presence of neutralizing antibodies of anti-PD-1 antibody for antidrug antibodies (ADAs) development
To evaluate the immunogenicity of anti-PD-1 antibody expressed by T3011 given as single agent and in combination with pembrolizumab post injection.
Measured: Up to 2 years from first dose of T3011
Presence and frequency of T3011 in injection site swab, saliva, and urine
To evaluate the virus shedding of T3011 following intratumoral injection
Measured: Up to 2 years from first dose of T3011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start17 Sep 2020
- Primary completion22 Sep 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmVira Pharma Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370587
- Sponsor's protocol ID
- CTIV1708
- Status last verified
- Oct 2025
- First submitted
- 14 Apr 2020
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No