Actively Recruiting
A Phase 12a, 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
Led by ImmVira Pharma Co. Ltd · Updated on 2025-10-08
30
Participants Needed
9
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and initial effects of T3011, given directly into tumors, alone and combined with the intravenous drug pembrolizumab. This Phase 12a open-label study focuses on adults with advanced or metastatic solid tumors, including melanoma, head and neck squamous cell carcinoma HNSCC, sarcoma, cutaneous squamous cell carcinoma cSCC, and non-small cell lung cancer NSCLC. The study aims to find safe dose levels and assess how well these treatments are tolerated and work in these cancer types. The study involves several groups Phase 1 tests increasing doses of T3011 alone to determine a recommended dose. Phase 2a Part 1 evaluates T3011 alone in participants with melanoma, HNSCC, sarcoma, and cSCC. Phase 2a Part 2 studies T3011 with pembrolizumab in NSCLC patients. A rollover arm allows participants whose cancer progresses on T3011 alone to receive the combination treatment. T3011 is given as an intratumoral injection every two weeks, and pembrolizumab is given intravenously every three weeks when combined. Participants will have tumor biopsies, imaging, and laboratory tests to monitor safety, drug levels, and cancer response. Researchers will track side effects and measure outcomes like tumor response and survival for up to two years after the first dose. Safety and tolerability are closely followed throughout, with additional monitoring for immune responses and drug presence in bodily fluids. Participants may be followed for up to one year after their last treatment dose to assess overall survival and long-term effects.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Disease progression after standard of care therapy or unlikely to benefit from standard treatments
- Histologically or pathologically confirmed locally recurrent or metastatic advanced malignancy (Phase 1)
- Locally recurrent or metastatic melanoma with up to 3 prior regimens for advanced disease (Arm A)
- Locally recurrent or metastatic HNSCC with progression after platinum chemotherapy and anti-PD-1/PDL1 blockade (Arm B)
- Sarcoma with up to 3 prior lines of anti-cancer therapies (Arm C)
- Locally recurrent or metastatic cutaneous squamous cell carcinoma with up to 3 prior regimens (Arm D)
- Advanced or recurrent NSCLC without EGFR mutation or ALK rearrangement, with 1 to 3 prior anti-cancer therapies (Arm E)
- Measurable disease per RECIST version 1.1
- At least 1 tumor lesion accessible for intratumoral injection
- ECOG performance status 0-1
- Life expectancy greater than 12 weeks
- Adequate organ function per lab tests
- Agreement to use contraception during and six months after study treatment
- Last anticancer therapy or radiotherapy at least 21 days prior to first dose
- Recovered from prior therapy toxicities
- Willingness to provide fresh tumor biopsy specimens
- Ability to understand and comply with study requirements
- Signed informed consent form
You will not qualify if you...
- Only uninjectable tumors
- Injectable tumors impinging on major airways or blood vessels
- For HNSCC, prior re-irradiation including carotid artery
- More than 3 distant metastatic lymph node regions or lesions larger than allowed size unless injected
- Prior treatment with other oncolytic viruses, tumor vaccines, cellular or gene therapy
- Prior intolerance to anti-PD-(L)1 antibodies or history of related lung disease
- Prior treatment with anti-PD-(L)1 antibody combined with IL-12
- Need for concurrent HSV-active drugs
- Live or attenuated vaccines within 4 weeks before study
- Immunodeficient states
- Pregnant or lactating
- Prior organ transplantation
- Active hepatitis B, C, HIV infection within 14 days before dosing
- Active autoimmune disease or need for chronic steroids or immunosuppressants within 4 weeks
- History or current central nervous system metastases
- Seizure disorders within 6 months before screening
- Active oral or skin herpes lesion at screening
- Active interstitial lung disease or pneumonitis
- Significant heart conditions or arrhythmias
- Allergic reactions to similar biological compounds
- Active SARS-CoV-2 infection
- Moderate to large pleural effusion, ascites, or pericardial effusion needing treatment
- Other systemic conditions that may interfere with study conduct or interpretation
Research Team
I
ImmVira Pharma Co. Ltd.
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