A Study of VET3-TGI in Patients With Solid Tumors

Официальное название

A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors

Обзор

VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with atezolizumab in patients with solid tumors (STEALTH-001).

Подробное описание

VET3-TGI was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. This is a Phase 1 dose escalation (and expansion) study with VET3-TGI administered by direct injection into tumor(s) or by intravenous infusion. The dose escalation has 4 groups: the first group (Group A) will determine the highest tolerated dose of VET3-TGI when injected into tumor(s); the second group (Group C) will determine the highest tolerated dose of VET3-TGI when infused into the vein. The third and fourth groups (Group B and D) will combine VET3-TGI with atezolizumab. These groups will begin at the highest tolerated dose determined in Group B and Group D, respectively.

Once the highest tolerated dose is found for each of these groups, that dose may be expanded to up to 15 additional patients to better examine the efficacy of VET3-TGI.

Вмешательства

• Препарат VET3-TGI
  Oncolytic vaccinia virus engineered with immunomodulatory transgenes
• Препарат Atezolizumab
  anti-pd-L1 antibody

Первичные конечные точки

• Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab [Срок оценки: 108 months]
• Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with atezolizumab [Срок оценки: 4 weeks]
• Determine the recommended Phase 2 dose [Срок оценки: 4 weeks]

Вторичные конечные точки (8)

• Efficacy assessment: overall response rate (ORR) [Срок оценки: 108 months]
• Efficacy assessment: Duration of response (DOR) [Срок оценки: 108 months]
• Efficacy assessment: disease control rate (DCR) [Срок оценки: 108 months]
• Efficacy assessment: Time to tumor progression (TTP) [Срок оценки: 108 months]
• Efficacy assessment: Progression free survival (PFS) [Срок оценки: 108 months]
• Overall survival [Срок оценки: 108 months]
• Immune changes in tissue and blood [Срок оценки: 6 weeks]
• VET3-TGI delivery and replication kinetics [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.
• Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab/PDL1 antibodies), and chemotherapy
• Measurable disease as per RECIST 1.1 criteria
• At least one tumor amenable to safe ITu injections and/or biopsies
• ECOG performance status 0 or 1
• Demonstrate adequate organ function
• Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions

Additional Inclusion criteria exist

Критерии исключения

• Prior systemic therapy washout (dependent upon the therapy)
• Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
• CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated.
• Prior history of myocarditis
• Known HIV/AIDS, active HBV or HCV infection.
• Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).

Additional Exclusion criteria exist

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• USC/Norris Comprehensive Cancer Center — Los Angeles
• UC Irvine Health — Orange
• University of Miami — Miami
• Community Health Network — Indianapolis
• UPMC- Hillman Cancer Center — Pittsburgh
• Mary Crowley Cancer Research — Dallas
• University of Texas MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06444815 · STEALTH-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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