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Solid TumorPhase 1/2NCT04780217

Intravenous T3011 Given as a Single Agent and in Combination With Other Therapy in Subjects With Advanced Solid Tumors

A Phase 1/2 study testing T3011 in people with Solid Tumor and Hepatocellular Carcinoma, run by ImmVira Pharma Co. Ltd at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Phase 1/2a Open-Label Dose Escalation and Dose Expansion Study of T3011 when Administered Intravenously as a Single Agent and in Combination with Other Therapy in Subjects with Advanced Solid Tumors Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
T3011
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
6 sitesUnited States
Study dates
10 Aug 2021to Aug 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • All subjects must meet the following criteria for inclusion:
  • Subjects with one of the following cancers:
  • Pathologically confirmed, locally recurrent or metastatic solid tumors, including, but not limited to NSCLC, hepatocellular carcinoma, colorectal cancer, ovarian cancer and endometrial cancer (Phase 1).
  • Disease progression on or unlikely to respond to SOC therapy at the discretion of the Investigator. SOC may include, but is not limited to, chemotherapy, targeted therapy or immunotherapy.
  • Age 18 years or older.
  • At least one target lesion per RECIST version 1.1.
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  • A previously irradiated lesions can be considered as target lesion only if PD has been unequivocally documented at that site since radiation.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
  • Life expectancy ≥ 12 weeks.
  • Adequate bone marrow function defined by absolute neutrophil count (ANC) of ≥ 1.5 × 109/L, platelet count of ≥ 100 × 109/L, and hemoglobin (Hb) of ≥ 8.5 g/dL.
  • Adequate hepatic function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) and total bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, wherein total bilirubin < 3.0 mg/dL is acceptable).
  • Adequate renal function defined as creatinine clearance > 50 mL/min as determined by the Cockcroft-Gault equation.
  • Female subjects must be surgically sterile (or have a monogamous partner who is surgically sterile), or be at least 2 years postmenopausal, or commit to using 2 acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 6 months following the last dose of study treatment. Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 6 months following the last dose of study treatment.
  • Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening within 14 days of dosing with T3011 and a negative urine pregnancy test pre-dose on C1D1 (assessment not required at C1D1 if completed within the previous 7 days of C1D1).
  • Note: A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).
  • Last dose of previous anticancer therapy ≥ 21 days; radiotherapy > 14 days (except prior focal palliative radiotherapy must have been completed at least 1 week prior to the first dose of study treatment); major surgery > 21 days; or last dose of therapy with tyrosine kinase inhibitors within 5 times the half-life of the inhibitor prior to first dose of study treatment. Last dose of checkpoint inhibitor ≥ 14 days, as long as treatment related toxicities resolve to ≤ Grade 1.
  • Resolution of all prior anticancer therapy toxicities (except for alopecia) to ≤ CTCAE version 5.0 Grade 1.
  • Note: subjects with immune-mediated endocrinopathies on replacement therapy are eligible. Subjects with toxicities attributed to the prior anticancer therapy and not expected to resolve, such as neuropathy or ototoxicity after platinum-based therapy, are permitted to enroll. Subjects with other toxicities > CTCAE version 5.0 Grade 1 may be enrolled with approval from the sponsor.
  • Willingness to provide pre- and post-treatment fresh tumor biopsy specimens, if tumor is easily accessible, as specified in the Schedule of Assessments. Subject is eligible to participate without providing fresh tumor biopsy specimens, with approval from the Medical Monitor.
  • Capable of understanding and complying with protocol requirements.
  • Signed and dated institutional review board/independent ethics committee (IRB/IEC) approved informed consent form (ICF) before any protocol-directed screening procedures are performed.

Who cannot join

  • Subjects are to be excluded from the study if they meet any of the following criteria:
  • Prior treatment with another OV (including T-VEC), tumor vaccines, cellular therapy or gene therapy.
  • Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.
  • Subjects with rapidly disease progression, defined as subjects who cannot tolerate interruption of systemic antitumor therapy for at least 8 weeks, according to the investigator's judgment.
  • Previous intolerance to anti-PD-(L)1 monoclonal antibody or previous history of immunotherapy induced non-infectious pneumonitis/interstitial lung disease.
  • Requires continued concurrent systemic therapy with any drug active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir). Topical use of drugs against HSV are allowed.
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  • Live, attenuated vaccines within 4 weeks prior to initiation of study treatment (subjects vaccinated with inactivated vaccines can be enrolled).
  • Primary or acquired immunodeficient states (leukemia, lymphoma, human immunodeficiency virus [HIV]/acquired immunodeficiency syndrome [AIDS]).
  • Active infection requiring systemic treatment.
  • Pregnant or lactating.
  • Splenectomy, previous allogenic tissue/solid organ transplant.
  • Positive serological test of hepatitis B virus (HBV) or hepatitis C virus at Screening.
  • Subjects who test positive for anti-hepatitis C antibody (anti-HCV) but negative for HCV ribonucleic acid (RNA) are considered eligible to participate in the study.
  • Subjects with infection of hepatitis B (positive hepatitis B surface antigen [HBsAg] result) will be excluded. Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible.
  • Active autoimmune disease or other medical conditions (e.g., active interstitial lung disease/pneumonitis or eczema, psoriasis, or other clinically significant dermatologic disorders) requiring chronic systemic steroid (> 10 mg/day prednisone or equivalent) or immunosuppressive therapy within 4 weeks prior to first administration of study treatment (unless agreed otherwise between the Medical Monitor and the Investigator on a case-by-case basis). Non-systemic corticosteroids (eg, topical, inhaled) are allowed.
  • Subjects with untreated and/or symptomatic metastatic central nervous system (CNS) disease, primary CNS tumors, leptomeningeal disease or spinal cord compression. However, subjects with brain/CNS metastases who have undergone surgery or radiotherapy, whose disease is stable and who have been on a stable dose of corticosteroids (≤ 10 mg prednisone or equivalent) for at least 4 weeks prior to the first administration of study treatment will be eligible.
  • History of another primary malignant tumor, except the following: 1) the patient has undergone potentially curative therapy with no evidence of that disease and recurrence for 3 years prior to the first dose of study treatment; 2) Adequately treated non-melanoma skin cancer or lentigo with no evidence of malignancy; 3) Adequately treated carcinoma in situ without evidence of disease.
  • Subjects with moderate to large amount of pleural effusion, ascites or pericardial effusion who need drug or medical intervention. Subject may be eligible to participate following discussion with investigator and approval from the sponsor.
  • Unexplained >38.5℃ fever (If the fever is caused by the tumor according to the investigator's judgment, the patient can be enrolled) occurs during the screening period or on the day of administration, which in the judgment of investigator, would interfere with patient participation in the study or evaluation of patient's efficacy.
  • History of seizure disorders within 6 months prior to Screening.
  • Active oral or skin herpes lesion at Screening.
  • Plan to receive any other anti-tumor therapy (including herbal therapy that has anti-tumor effects) during treatment with study drug.
  • History of congestive heart failure (> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest), 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 or their excipients.
  • History of psychiatric disorders that would interfere with cooperation with the requirements of the trial or is still requiring for medication control.
  • History of substance abuse (including alcohol) within 6 months prior to signing informed consent.
  • 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

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Prisma Health - Upstate

    Greenville, South Carolina, 29601

  • Virginia Cancer Specialists

    Greenville, South Carolina, 29605

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Banner MD Anderson Cancer Center

    Phoenix, Arizona, 85012

  • BRCR Medical Center Inc

    Plantation, Florida, 33322

Other trials in United States

About this study

Official title: A Phase 1/2a Open-Label Dose Escalation and Dose Expansion Study of T3011 When Administered Intravenously as a Single Agent and in Combination With Other Therapy in Subjects With Advanced Solid Tumors

A Phase 1/2a Open-Label Dose Escalation and Dose Expansion Study of T3011 when Administered Intravenously as a Single Agent and in Combination with Other Therapy in Subjects with Advanced Solid Tumors

Read the detailed description

This is a multicenter, open-label study conducted in two phases (as outlined in the subsections below):

Phase 1: T3011 administered intravenously as a single agent in subjects with pathologically confirmed locally recurrent or metastatic solid tumors, who have failed or declined SOC treatment. Phase 1 will use a 3+3 design to evaluate escalating doses of single agent T3011. Cohorts of three subjects will be enrolled at each T3011 dose level with expansion to six subjects, if necessary, to assess toxicity. Total enrollment will depend on the toxicities observed, with approximately 36-42 evaluable subjects enrolled in phase 1.

Phase 2a: An expansion study will be conducted based on phase 1 results.

Being tested
T3011
Keywords
solid tumor
Medical subject headings
Carcinoma, Hepatocellular, Colorectal Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T3011Biological

    T3011 will be administered through IV drip or pumping.

Study groups in NCT04780217
Study groupRoleWhat they receive
Phase 1ExperimentalT3011 Single Agent Dose Escalation in participants with solid tumors
Receives: Biological: T3011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety and tolerability of escalating doses of single agent IV T3011 Characterize DLTs and identify the MTD and/or the RP2D of single agent IV T3011

    Number of participants with Adverse Events (TEAEs, SAEs, AESIs), with abnormal clinically significant vital signs, with abnormal physical examination findings and abnormal laboratory tests results

    Measured: Up to 2 years from first dose of T3011

Secondary outcomes (8)

  1. Evaluate the immunogenicity of single agent IV T3011.

    Measurement of ADAs and Nabs of IL-12, anti-PD-1 antibody and HSV-1 (test Nabs when ADAs are positive).

    Measured: Up to 2 years from first dose of T3011

  2. Overall response rate (ORR)

    Defined as the percentage of subjects who have best overall response (BOR) as CR or partial response (PR), as determined according to RECIST v1.1. CR or PR will be claimed only if the criteria for each are met at a subsequent time point at 4-8 weeks later.

    Measured: Up to 2 years from first dose of T3011

  3. Disease control rate (DCR)

    Defined as the percentage of subjects who have BOR as CR or PR or stable disease (SD) (if a subject develops SD, it needs to be confirmed at least 6 weeks later, that is, SD lasts at least 6 weeks), as determined according to RECIST v1.1.

    Measured: Up to 2 years from first dose of T3011

  4. Duration of response (DOR)

    Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever comes first), as determined according to RECIST v1.1

    Measured: Up to 2 years from first dose of T3011

  5. Progression-free survival (PFS)

    Defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause (whichever comes first), as determined according to RECIST v1.1.

    Measured: Up to 2 years from first dose of T3011

  6. Overall Survival (OS)

    OS is defined as the time from enrollment to death from any cause.

    Measured: Up to 2 years from first dose of T3011

  7. time to treatment failure（TTF）

    Defined as a composite endpoint measuring time from the date of first treatment to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.

    Measured: Up to 2 years from first dose of T3011

  8. PFS2

    Defined as the time from the date of initiation of new antitumor therapy to the first occurrence of disease progression after new antitumor therapy or death from any cause (whichever comes first)

    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.

  1. First posted3 Mar 2021
  2. Study start10 Aug 2021
  3. Primary completionMar 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04780217
Sponsor's protocol ID
MVR-T3011-003
Status last verified
Feb 2024
First submitted
6 Feb 2021
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing T3011 in people with Solid Tumor and Hepatocellular Carcinoma, run by ImmVira Pharma Co. Ltd at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety and tolerability of escalating doses of single agent IV T3011 Characterize DLTs and identify the MTD and/or the RP2D of single agent IV T3011 (time frame: Up to 2 years from first dose of T3011). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04780217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

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