Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

Официальное название

A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

Обзор

This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.

Вмешательства

• Препарат TJ033721 (givastomig)
  Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
• Препарат TJ033721 (givastomig) , nivolumab, chemotherapy
  Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy
• Препарат TJ033721 (givastomig), chemotherapy
  Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), chemotherapy
• Препарат TJ033721 (givastomig), durvalumab, chemotherapy
  Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), durvalumab, chemotherapy

Первичные конечные точки

• Dose-limiting toxicities (DLTs) [Срок оценки: 28 days]
• Incidence and severity of AEs [Срок оценки: Up to 100 days post last dose]
• Maximum tolerated or administered dose (MTD, MAD) [Срок оценки: 28 Days]

Вторичные конечные точки (5)

• Pharmacokinetic (PK) Parameters: AUC∞ [Срок оценки: Up to 100 days post last dose]
• Pharmacokinetic (PK) Parameters: AUCt [Срок оценки: up to 100 days post last dose]
• Pharmacokinetic (PK) Parameters: Cmax [Срок оценки: up to 100 days post last dose]
• Pharmacokinetic Parameters: Tmax [Срок оценки: up to 100 days post last dose]
• Pharmacokinetic Parameters: T1/2 [Срок оценки: up to 100 days post last dose]

Критерии участия

Критерии включения

Part 1 - Monotherapy Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options.

Part 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma;

Part 3: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma;

Part 4: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed biliary tract cancer.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function
• Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)

For dose expansion and Part 2, Part 3, Part 4 Combination subjects:

• Must have CLDN18.2-positive tumor expression

Критерии исключения

• Prior exposure to CLDN18.2 -targeted therapy
• Prior exposure to 4-1BB agonists
• Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ
• Known active or chronic Hepatitis B or Hepatitis C, other hepatitides
• Unstable/active ulcer or digestive tract bleeding within 6 weeks
• Active autoimmune disease requiring systemic treatment within the past 2 years
• Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment
• Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;
• New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe/unstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) in the previous 6 months
• Diagnosis of immunodeficiency such as known active HIV
• Any active infection requiring parenteral treatment

For Part 2, 3, 4 Combination subjects:

• Prior treatment with anti-PD-1 or PD-L1 agent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 11 центров

• Stern Center for Cancer Clinical Trials and Research — Orange
• UCHealth Cancer Care - Anschutz Medical Campus — Aurora
• Horizon Oncology Research, LLC. — Layfayette
• Mass General Hospital — Boston
• Rutgers Cancer Institute of New Jersey — New Brunswick
• NYU Langone — New York
• Memorial Sloan Kettering Cancer Center — New York
• Carolina BioOncology Institute — Huntersville
• … и ещё 3 центра

Китай · 10 центров

• The Second Hospital of Anhui Medical University — Хэфэй
• Beijing Cancer Hospital — Пекин
• Sixth Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
• HARBIN Medical University Cancer Hospital — Харбин
• Henan Cancer Hospital — Чжэнчжоу
• Hubei Cancer Hospital — Ухань
• The First Hospital of China Medical University — Шэньян
• Zhongshan Hospital, Fudan University — Шанхай
• … и ещё 2 центра

Идентификаторы

NCT: NCT04900818 · TJ033721STM101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗