Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Age 18 years or older. 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.
- - locally recurrent or metastatic melanoma.
- - locally recurrent or metastatic HNSCC.
- - Sarcoma.
- - locally recurrent or metastatic cSCC.
- - Histologically or pathologically confirmed NSCLC that is advanced or recurrent, without EGFR mutation or ALK rearrangement.
Exclusion Criteria:1. Have only uninjectable tumors.. 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|ImmVira Pharma Co. Ltd|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Solid Tumor, Melanoma, HNSCC, Sarcoma, Squamous Cell Carcinoma, NSCLC|
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.
Experimental: Phase 1
T3011 single agent dose escalation in participants with solid tumors
Experimental: Phase 2a Part 1 Arm A
RP2D T3011 single agent in participants with melanoma
Experimental: Phase 2a Part 1 Arm B
RP2D T3011 single agent in participants with other solid tumors
Experimental: Phase 2a Part 2 Arm C
RP2D T3011 + pembrolizumab in participants with NSCLC
Experimental: Rollover Arm
RP2D T3011 + pembrolizumab in participants who have progressed on T3011 single agent
Biological: - T3011
T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
Combination Product: - T3011 + pembrolizumab
T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.