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

NCT04780217 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: MVR-T3011-003
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

Solid Tumor; Hepatocellular Carcinoma; Colorectal Cancer; NSCLC; Ovarian Cancer; Endometrial Cancer

Keywords

solid tumor

Outcome Measures

Primary Outcomes (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

  Up to 2 years from first dose of T3011

Secondary Outcomes (8)

• Evaluate the immunogenicity of single agent IV T3011.

  Up to 2 years from first dose of T3011

• Overall response rate (ORR)

  Up to 2 years from first dose of T3011

• Disease control rate (DCR)

  Up to 2 years from first dose of T3011

• Duration of response (DOR)

  Up to 2 years from first dose of T3011

• Progression-free survival (PFS)

  Up to 2 years from first dose of T3011

Study Arms (1)

Phase 1

EXPERIMENTAL

T3011 Single Agent Dose Escalation in participants with solid tumors

Biological: T3011

Interventions

T3011 BIOLOGICAL

T3011 will be administered through IV drip or pumping.

Phase 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ImmVira Pharma Co. Ltd: lead

Study Sites (6)

Banner MD Anderson Cancer Center

Phoenix, Arizona, 85012, United States

Location

BRCR Medical Center Inc

Plantation, Florida, 33322, United States

Location

Prisma Health - Upstate

Greenville, South Carolina, 29601, United States

Location

Virginia Cancer Specialists

Greenville, South Carolina, 29605, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

Related Links

• ImmVira Pharma Co. LTD

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Colorectal Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: March 3, 2021
• Study Start: August 10, 2021
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)