A Phase I/II Study of TRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone（T-CHP） in Previously Untreated Patients With CD20-positive DLBCL

Официальное название

A Phase I/II Study Evaluating the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of TRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone（T-CHP） in Previously Untreated Patients With CD20-positive DLBCL

Обзор

This trial is a multicenter, open-label, single-arm, dose-escalation and dose-expansion clinical trial. The dose was increased according to the "3 + 3" rule. Patients with previously untreated patients with CD20-positive DLBCL were selected to evaluate the safety, tolerance (DLT, MTD), pharmacokinetics, and anti-tumor activity of TRS005 in combination with standard doses of cyclophosphamide, doxorubicin, and prednisone（T-CHP） by intravenous drip every 3 weeks.

Вмешательства

• Препарат TRS005
  TRS005 will be administered at a starting dose of 0.8mg/kg IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles (up to 8).
• Препарат Cyclophosphamide
  Cyclophosphamide will be administered at 750 milligrams per square meter (mg/m\^2) IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.
• Препарат Doxorubicin
  Doxorubicin will be administered at 50 mg/m\^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.
• Препарат Prednisolone
  Prednisolone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.

Первичные конечные точки

• Part I: Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD) [Срок оценки: Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21)]
• Part I and II: Adverse Events [Срок оценки: Day 1 up to approximately 6 months]

Вторичные конечные точки (6)

• Overall Response Rate (ORR) [Срок оценки: At the end of treatment (Month 6)]
• Duration of Response (DOR) [Срок оценки: Up to 24 months]
• Progression-Free Survival (PFS) [Срок оценки: Up to 24 months]
• Overall Survival (OS) [Срок оценки: Up to 24 months]
• Immunogenicity [Срок оценки: At the end of treatment (Month 6)]
• Serum concentration [Срок оценки: At the end of cycle 4 (each cycle is 21 days)]

Критерии участия

Критерии включения

• 1\. Part I: Age 18 -65 years old; Part II: Aged ≥ 18 years old, both male and female.
• 2\. Previously untreated patients with CD20-positive DLBCL diagnoses by 2022 WHO.
• 3\. Measurable disease of at least 15mm (node)/10mm (extranodal).
• 4\. ECOG performance status 0-2.
• 5\. International Prognostic Index (IPI) score of 2-5.
• 6\. Estimated survival time ≥6 months.
• 7\. Having sufficient organ function.
• 8\. Female and male patients of childbearing age and their spouses are willing to carry out adequate contraception throughout the study period, and female patients of childbearing age must have negative serum pregnancy test within 7 days before the first administration.
• 9\. Patients voluntarily agree to participate in the study and to sign the informed consent form.

Критерии исключения

• 1\. Contraindication to any of the individual components of study drugs, including prior receipt of xenoproteins, biological agents.
• 2\. Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load; Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load; Human immunodeficiency virus (HIV) seropositive.
• 3\. Clinically apparent central nervous system (CNS) lymphoma.
• 4\. Patient has ≥ Grade 2 peripheral neuropathy.
• 5\. Investigator-assessed diabetes uncontrolled by drug therapy.
• 6\. Clinically significant third space fluid accumulation.
• 7\. Patients with other malignancies within the past 5 years.
• 8\. With active autoimmune diseases.
• 9\. Accompanied by serious cardiovascular diseases.
• 10\. Accompanied by serious diseases and serious active infections.
• 11\. The dosage of steroid hormone (prednisone phase equivalent) used greater than 20mg/ day within 28 days prior to first administration for more than 14 consecutive days, or immunosuppressive treatment.
• 12\. Various vaccines were inoculated within 28 days prior to first administration;
• 13\. Major surgery (except diagnostic biopsy) within 28 days prior to first administration or during the study period.
• 14\. Participate in clinical trials of other drugs or medical devices within 28 days prior to first administration.
• 15\. Serious medical or psychiatric illness likely to interfere with participation in this study.
• 16\. Investigators assessed as unsuitable to participate in this study for other reasons.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese Academy of Medical Sciences, Cancer Hospital — Пекин

Идентификаторы

NCT: NCT07035379 · TRS00501003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗