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Active (not recruiting) Phase 1/2 NCT04699188

Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Phase 1/2 – combined early trial
Conditions: 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

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 15
Australia (1)
Novartis Investigative Site
Melbourne , Victoria
Belgium (1)
Novartis Investigative Site
Leuven
Canada (1)
Novartis Investigative Site
Montreal , Quebec
China (1)
Novartis Investigative Site
Guangzhou , Guangdong
Denmark (1)
Novartis Investigative Site
Copenhagen
France (1)
Novartis Investigative Site
Lyon
Hong Kong (1)
Novartis Investigative Site
Hong Kong
Italy (1)
Novartis Investigative Site
Brescia , BS
Japan (1)
Novartis Investigative Site
Nagoya , Aichi-ken
Netherlands (1)
Novartis Investigative Site
Amsterdam
Singapore (1)
Novartis Investigative Site
Singapore
South Korea (1)
Novartis Investigative Site
Seoul
Spain (1)
Novartis Investigative Site
Santiago Compostela , A Coruna
Taiwan (1)
Novartis Investigative Site
Taipei
United States (1)
Emory University School of Medicine-Winship Cancer Institute
Atlanta , Georgia
Technical details
Status
Active (not recruiting)
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
24.02.2021
Completion date
25.01.2027
Registry ID
NCT04699188
Source
anzctr
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