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Активно (без набиране) Фаза 1/2 NCT05609370

A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer

Спонсор: BeiGene

Налично на: БГ
Обобщение
This is a Phase 1b/2 study to investigate the efficacy and safety of LBL-007 plus tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine, and LBL-007 in combination with bevacizumab plus fluoropyrimidine versus bevacizumab plus fluoropyrimidine to participants with colorectal cancer.
Кой може да участва
Inclusion Criteria: * Participant must have measurable disease as defined per RECIST version 1.1 * Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer \[AJCC\] 8th edition) * No prior systemic therapy for colorectal cancer (CRC) in the metastatic setting except for the induction treatment of first-line therapy. Note: Local regional treatment performed during induction systemic treatment is allowed * Participants who have completed the first-line induction treatment, with an overall response of stable disease or better. The duration of induction treatment should be completed within approximately 6 months. The first dose of study treatment needs to occur within 2 weeks (for 2-week regimen) or 3 weeks (for 3-week regimen) to 6 weeks after Day 1 of the last cycle of induction therapy Exclusion Criteria: * Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible * Progressive disease occurred less than 6 months from completion of any prior neoadjuvant therapy (ie, chemotherapy with or without radiotherapy) or adjuvant therapy (ie, chemotherapy with or without radiotherapy), whichever occurred later * Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment * Any prior therapy targeting T-cell stimulation or checkpoint pathways * Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations * Have locally or centrally confirmed microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method Note: Other protocol defined criteria may apply.
Места на провеждане 4
Австралия (1)
Blacktown Cancer and Haematology Centre
Blacktown , New South Wales
Китай (1)
The Second Hospital of Anhui Medical University
Hefei , Anhui
Puerto Rico (1)
Pan American Oncology Trials, Llc
Rio Piedras
САЩ (1)
Alaska Oncology and Hematology, Llc
Anchorage , Alaska
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
29.01.2023
Крайна дата
31.12.2026
Регистрационен номер
NCT05609370
Източник
anzctr
Запитване за медицински туризъм

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