Overview

A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors

Status:
Active, not recruiting

Trial end date:
2022-05-10

Target enrollment:
0

Participant gender:
All

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 the safety/tolerability, pharmacokinetic and pharmacodynamic profile of the orally administered LNP3794 (BI3011441) as monotherapy at selected dose levels.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Lupin Ltd.

Criteria

Inclusion Criteria:

1. Subjects ≥18 years of age

2. Pathologically documented, locally-advanced or metastatic solid malignancy with NRAS
or KRAS mutation

3. At least one target lesion that can be measured per RECIST version 1.1

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

5. Adequate organ function (bone marrow, hepatic, renal, cardiovascular)

6. Documented disease progression despite appropriate prior standard therapies or
subjects for whom no standard therapy exists for their tumor type and disease stage

7. Reproductive criteria (as defined in the protocol)

Exclusion Criteria:

1. Subjects with symptomatic central nervous system (CNS) metastases

2. History of another primary malignancy, with the exception of locally excised
nonmelanoma skin cancer and carcinoma in situ of uterine cervix

3. Known active hepatitis B infection or hepatitis C infection

4. Known pre-existing interstitial lung disease

5. Known diagnosis of human immunodeficiency virus (HIV) infection

6. History or current evidence/risk of retinal vein occlusion (RVO) or central serous
retinopathy; or known risk factors for RVO or central serous retinopathy

7. 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

8. Impaired cardiac function or clinically significant cardiac diseases

9. Previous treatment with RAS or MEK targeting agents

10. 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