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Активно (без набиране) Фаза 3 NCT05425940

Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

Фаза 3 – широко изпитване преди одобрение
Заболявания: Colorectal Cancer

Спонсор: Exelixis

Налично на: БГ
Обобщение
The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.
Кой може да участва
Key Inclusion Criteria: * Participants with histologically or cytologically confirmed adenocarcinoma of the colon or rectum. * Documented rat sarcoma (RAS) status (mutant or wild-type \[WT\]), by tissue-based analysis. * Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis. * Has received SOC anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies. * Systemic SOC anticancer therapy if approved and available in the country where the participant is randomized. * Radiographic progression during treatment with or within 4 months following the last dose of the most recent approved SOC chemotherapy regimen. * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the Investigator. * Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization. * Recovery to baseline or ≤ Grade 1 severity (common terminology criteria for adverse events \[CTCAE\] version 5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Adequate organ and marrow function. * Fertile participants and their partners must agree to use highly effective methods of contraception during the course of the study and after the last dose of treatment. * Females of childbearing potential must not be pregnant at screening. Key Exclusion Criteria: * Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or programmed cell death protein-1/and its ligand (PD-L1/PD-1) targeting immune checkpoint inhibitors (ICIs). * Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization. * Receipt of any type of anticancer antibody therapy, systemic chemotherapy, or hormonal anti-cancer therapy within 3 weeks (or bevacizumab within 4 weeks) before randomization. * Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before randomization. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before randomization. * Has uncontrolled, significant intercurrent or recent illness. * Major surgery (example, gastrointestinal (GI) surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization. * Systemic treatment with, or any condition requiring, either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization. * Corrected QT interval calculated by the Fridericia formula (QTcF) \> 460 milliseconds (ms) within 10 days before randomization. * History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent. * Pregnant or lactating females. * Inability to swallow study treatment formulation, inability to receive IV administration, or presence of GI condition that might affect the absorption of study drug. * Previously identified allergy or hypersensitivity to components of the study treatment formulations. * Any other active malignancy or diagnosis of another malignancy within 2 years before randomization. Exceptions are noted in the protocol. * Administration of a live, attenuated vaccine within 30 days before randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Места на провеждане 15
Австралия (1)
Exelixis Clinical Site #83
Albury
Белгия (1)
Exelixis Clinical Site #43
Antwerp
Франция (1)
Exelixis Clinical Site #52
Besançon
Германия (1)
Exelixis Clinical Site #127
Hanover , Niedersach
Hong Kong (1)
Exelixis Clinical Site #25
Hong Kong
Унгария (1)
Exelixis Clinical Site #128
Nyíregyháza , Szabolcs-Szatmar-Bereg County
New Zealand (1)
Exelixis Clinical Site #57
Auckland
Полша (1)
Exelixis Clinical Site #20
Bydgoszcz
Сингапур (1)
Exelixis Clinical Site #132
Singapore
Южна Корея (1)
Exelixis Clinical Site #36
Goyang-si
Испания (1)
Exelixis Clinical Site #78
Barcelona
Taiwan (1)
Exelixis Clinical Site #119
Guishan
Тайланд (1)
Exelixis Clinical Site #62
Chiang Mai
Великобритания (1)
Exelixis Clinical Site #130
Bristol , England
САЩ (1)
Exelixis Clinical Site #65
Jonesboro , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
07.09.2022
Крайна дата
01.01.2027
Регистрационен номер
NCT05425940
Източник
anzctr
Запитване за медицински туризъм

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