A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer

Официальное название

Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of MRG007 Combination Therapy in Patients With Advanced Colorectal Cancer

Обзор

This is a Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MRG007 combination therapy in patients with advanced colorectal cancer.

Вмешательства

• Препарат MRG007
  MRG007 will be administrated as specified in the protocol.
• Препарат 5-Fluorouracil / Leucovorin Calcium
  5-Fluorouracil / Leucovorin Calcium will be administrated as specified in the protocol.
• Препарат Bevacizumab
  Bevacizumab will be administrated as specified in the protocol.
• Препарат Oxaliplatin
  Oxaliplatin will be administrated as specified in the protocol.
• Препарат PD-1/VEGF antibody
  PD-1/VEGF antibody will be administrated as specified in the protocol.
• Препарат Capecitabine
  Capecitabine will be administrated as specified in the protocol.

Первичные конечные точки

• Dose Limiting Toxicity (DLT) [Срок оценки: From the first dose to 30 days after the last dose]
• Serious Adverse Events (SAEs) [Срок оценки: From the first dose to 30 days after the last dose]
• Adverse Event (AE) [Срок оценки: From the first dose to 30 days after the last dose]
• Recommended Phase 2 Dose(RP2D) and/or Maximum Tolerated Dose (MTD) [Срок оценки: From the first dose to 30 days after the last dose]
• Objective Response Rate (ORR) [Срок оценки: Assessments will be performed every 6 weeks (± 7 days) following the first dose.]

Вторичные конечные точки (7)

• Serum Concentration [Срок оценки: up to 2 years]
• Anti-Drug Antibody (ADA) [Срок оценки: up to 2 years]
• Neutralizing antibody (NAb) [Срок оценки: up to 2 years]
• Duration of Response (DOR) [Срок оценки: Through study completion, an average 2 years]
• Disease Control Rate (DCR) [Срок оценки: Through study completion, an average 2 years]
• Progression-Free Survival (PFS) [Срок оценки: Through study completion, an average 2 years]
• Overall Survival (OS) [Срок оценки: Through study completion, an average 2 years]

Критерии участия

Критерии включения

• Expected survival of ≥ 3 months.
• Tumor tissue specimens must be provided for relevant biomarker testing. If archived tissue specimens are unavailable, a new biopsy must be performed.
• Pathologically confirmed, unresectable locally advanced or metastatic colorectal adenocarcinoma.
• At least one measurable lesion according to RECIST v1.1 criteria. Measurable lesions should not have received prior radiotherapy; however, measurable lesions located within a prior radiation field or after local therapy may be selected as target lesions if disease progression is confirmed.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Adequate organ function must be demonstrated.
• Sexually active males and females of childbearing potential must agree to use highly effective contraceptive measures from the time of signing the informed consent form until 6 months after the last dose of the investigational drug. Females of childbearing potential include premenopausal females and postmenopausal females within 1 year after menopause. Females of childbearing potential must have a negative serum pregnancy test result ≤ 7 days prior to the first dose and before randomization.

Критерии исключения

• Trial participants with known deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H).
• Trial participants with synchronous or multiple primary malignancies.
• Residual toxicity ≥ Grade 2 resulting from prior anti-tumor therapy.
• Symptomatic central nervous system (CNS) metastases and/or leptomeningeal metastases.
• History of severe cardiovascular disease.
• Cerebrovascular accident, pulmonary embolism, or deep vein thrombosis occurring within 3 months prior to the first dose of the investigational drug; thrombosis associated with implanted venous ports or catheters; or superficial vein thrombosis, except for patients with stable thrombosis after standard anticoagulation therapy. Prophylactic use of low-dose low-molecular-weight heparin is permitted.
• Clinically symptomatic moderate or larger volume pleural, ascitic, or pelvic effusions requiring clinical intervention, or clinically symptomatic pericardial effusion.
• History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the investigational drug that has not healed following surgical treatment; risk of bowel obstruction or bowel perforation; extensive bowel resection; poorly controlled Crohn's disease, ulcerative colitis, or other gastrointestinal autoimmune or inflammatory diseases; presence of pyloric obstruction and/or persistent recurrent vomiting.
• Active chronic hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
• Hypersensitivity to any component or excipient of MRG007, or known ≥ Grade 3 hypersensitivity to other prior anti-CDH17 antibodies or other monoclonal antibodies.
• Body weight loss ≥ 10% during the screening period. Any severe and/or uncontrolled systemic disease that, in the opinion of the investigator and the sponsor, renders the participant unsuitable for participation in this study.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University cancer Hospital — Пекин

Идентификаторы

NCT: NCT07737600 · MRG007-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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