Status:
COMPLETED
A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
Lead Sponsor:
Lupin Ltd.
Conditions:
NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, open-label, dose escalation study of LNP3794 (BI3011441) in subjects with NRAS/KRAS mutated advanced or metastatic refractory solid tumors. The purpose of this study is to evaluate ...
Eligibility Criteria
Inclusion
- Subjects ≥18 years of age
- Pathologically documented, locally-advanced or metastatic solid malignancy with NRAS or KRAS mutation
- At least one target lesion that can be measured per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
- Documented disease progression despite appropriate prior standard therapies or subjects for whom no standard therapy exists for their tumor type and disease stage
- Reproductive criteria (as defined in the protocol)
Exclusion
- Subjects with symptomatic central nervous system (CNS) metastases
- History of another primary malignancy, with the exception of locally excised nonmelanoma skin cancer and carcinoma in situ of uterine cervix
- Known active hepatitis B infection or hepatitis C infection
- Known pre-existing interstitial lung disease
- Known diagnosis of human immunodeficiency virus (HIV) infection
- History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy; or known risk factors for RVO or central serous retinopathy
- Any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator, Sponsor, or contract research organization, could affect the subject's participation in the study
- Impaired cardiac function or clinically significant cardiac diseases
- Previous treatment with RAS or MEK targeting agents
- Chemotherapy, biologic therapy, immunotherapy, radiotherapy, or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study treatment
Key Trial Info
Start Date :
September 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05187858
Start Date
September 22 2020
End Date
June 30 2022
Last Update
March 17 2023
Active Locations (4)
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1
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200 Bruxelles
2
Amsterdam UMC
Amsterdam, Netherlands, 1081 HV
3
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
4
The Christie NHS Foundation
Manchester, United Kingdom, M20 4BX