Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Фаза 1/2 – комбинирано ранно изпитване
Заболявания:
KRAS G12C Mutant Solid Tumors
Carcinoma, Non-Small-Cell Lung
Carcinoma, Colorectal
Cancer of Lung
Cancer of the Lung
Lung Cancer
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms
Спонсор: Novartis Pharmaceuticals
Налично на:
БГ
Обобщение
This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.
Кой може да участва
Inclusion Criteria:
* Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies
* ECOG Performance Status of 0 or 1
* At least one measurable lesion as defined by RECIST 1.1
* Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion
Exclusion Criteria:
* Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
* Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible
* Clinically significant cardiac disease or risk factors at screening
* A medical condition that results in increased photosensitivity Other protocol-defined inclusion/exclusion criteria may apply.
Места на провеждане
15
Австралия (1)
Novartis Investigative Site
Melbourne , Victoria
Белгия (1)
Novartis Investigative Site
Leuven
Канада (1)
Novartis Investigative Site
Montreal , Quebec
Китай (1)
Novartis Investigative Site
Guangzhou , Guangdong
Дания (1)
Novartis Investigative Site
Copenhagen
Франция (1)
Novartis Investigative Site
Lyon
Hong Kong (1)
Novartis Investigative Site
Hong Kong
Италия (1)
Novartis Investigative Site
Brescia , BS
Япония (1)
Novartis Investigative Site
Nagoya , Aichi-ken
Нидерландия (1)
Novartis Investigative Site
Amsterdam
Сингапур (1)
Novartis Investigative Site
Singapore
Южна Корея (1)
Novartis Investigative Site
Seoul
Испания (1)
Novartis Investigative Site
Santiago Compostela , A Coruna
Taiwan (1)
Novartis Investigative Site
Taipei
САЩ (1)
Emory University School of Medicine-Winship Cancer Institute