Phase I Study of LXH254 in Patients With Advanced Solid Tumors Haboring MAPK Pathway Alterations

Stopped early · Phase 1

Conditions studied: NSCLC, Ovarian Cancer, Melanoma, Other Solid Tumors

In brief

A Phase I Study of LXH254 in Patients With Advanced Solid Tumors That Harbor MAPK Pathway Alterations.

Key facts

Study ID

NCT02607813

Run by

Novartis Pharmaceuticals

People needed

142

Starts

2016-01-18

Expected to finish

2022-02-19

Last updated by the study team

2022-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients participating in this clinical trial must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Presence of at least one measurable lesion according to RECIST v1.1.
• Documented MAPK alteration
• Additional inclusion criteria for the Dose Expansion part: LXH254 in combination with PDR001:
• Patients with confirmed KRAS-mutated NSCLC
• Patients with confirmed NRAS-mutated melanoma (cutaneous melanoma only)

You may not qualify if…

• Prior treatment with a BRAFi, MEKi and/or pan-RAF inihibitors for patients to be enrolled in the dose expansion part.
• Exceptions may be made after documented agreement between Novartis and Investigator.
• History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
• Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
• Patients receiving proton pump inhibitors which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
• Pregnant or nursing (lactating) women
• Additional exclusion criteria for LXH254 in combination with PDR001
• History of severe hypersensitivity reactions, which in the opinion of the investigator may cause in increased risk of serious infusion reaction.
• Known human immunodeficiency virus (HIV).
• Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
• Active, known or suspected autoimmune disease.
• Active infection requiring systemic antibiotic therapy
• Patients requiring systemic steroid therapy or any immunosuppressive therapy (≥10mg/day prednisone or equivalent) which cannot be discontinued at least 7 days prior to first dose of study treatment.
• Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
• Other inclusion/exclusion criteria as per protocol may apply.

Where it is running

• Massachusetts General Hospital MGH Cancer Center — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center SC - LXH254X2101 — New York, New York, United States
• UT M.D Anderson Cancer Center SC - LXH254X2101 — Houston, Texas, United States
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Modena, MO, Italy
• Novartis Investigative Site — Naples, Italy
• Novartis Investigative Site — Chuo Ku, Tokyo, Japan
• Novartis Investigative Site — Groningen, Netherlands
• Medical Oncology, Erasmus MC — Rotterdam, Netherlands
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Zurich, Switzerland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.