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

NCT ID: NCT05187858

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2022-06-30

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

Conditions

NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LNP3794

Participants will receive LNP3794 orally once daily at different doses in 28 day cycles on a continuous basis

Group Type: EXPERIMENTAL

LNP3794

Intervention Type: DRUG

LNP3794 capsules administered orally once daily

Interventions

LNP3794

LNP3794 capsules administered orally once daily

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lupin Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dhanajay Bakhle, MD

Role: STUDY_CHAIR

Lupin Limited

Locations

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Amsterdam UMC

Amsterdam, , Netherlands

Sarah Cannon Research Institute

London, , United Kingdom

The Christie NHS Foundation

Manchester, , United Kingdom

Countries

Belgium; Netherlands; United Kingdom

Other Identifiers

LRP/LNP3794/2020/001

Identifier Type: -

Identifier Source: org_study_id