Clinical trial · Interventional
A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
A Phase I Open-Label Study of LNP3794 (BI3011441) in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LNP3794 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LNP3794
- description
- Participants will receive LNP3794 orally once daily at different doses in 28 day cycles on a continuous basis
- interventionNames
- Drug: LNP3794
Primary outcomes (1)
- measure
- Number of subjects with dose limiting toxicities (DLTs) at each dose level during the first cycle
- timeFrame
- up to Day 28
- description
- Dose limiting toxicities will be evaluated through the first cycle (each cycle is 28 days)
Secondary outcomes (7)
- measure
- Number of subjects with DLTs during the entire on-treatment period
- timeFrame
- up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available