NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid TumorsPhase 1NCT05187858
A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
A Phase 1 study testing LNP3794 in people with NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors, run by Lupin Ltd. at 4 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
- What is being tested?
- LNP3794
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 22 Sep 2020to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
Sarah Cannon Research Institute
London, W1G 6AD
The Christie NHS Foundation
Manchester, M20 4BX
About this study
Official title: A Phase I Open-Label Study of LNP3794 (BI3011441) in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
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.
- Being tested
- LNP3794
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNP3794Drug
LNP3794 capsules administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| LNP3794 | Experimental | Participants will receive LNP3794 orally once daily at different doses in 28 day cycles on a continuous basis Receives: Drug: LNP3794 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with dose limiting toxicities (DLTs) at each dose level during the first cycle
Dose limiting toxicities will be evaluated through the first cycle (each cycle is 28 days)
Measured: up to Day 28
Secondary outcomes (7)
Number of subjects with DLTs during the entire on-treatment period
Dose limiting toxicities will be evaluated through the entire on-treatment period
Measured: up to 2 years
Number of subjects with Grade ≥3 treatment-related adverse events (AEs)
Grade ≥3 treatment-related adverse events will be evaluated through the entire on-treatment period
Measured: up to 2 years
Number of subjects with treatment-related AEs at each dose level
Treatment-related AEs at each dose level will be evaluated through the entire on-treatment period
Measured: up to 2 years
Maximum Plasma Concentration (Cmax) of LNP3794
Cmax is the maximum observed plasma concentration.
Measured: Cycle 1 (each cycle is 28 days) Day 1 and Day 14
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last])
AUC[0-last] is the measure of plasma drug concentration from time zero to the time of last quantifiable concentration.
Measured: Cycle 1 (each cycle is 28 days) Day 1 and Day 14
Area under the concentration-time curve from time zero to the end of dosing interval (AUC[0-tau])
AUC[0-tau] is the measure of plasma drug concentration from time zero to the end of dosing interval.
Measured: Cycle 1 (each cycle is 28 days) Day 1 to 2 and Day 14 to 15
Time to maximum concentration (Tmax)
Tmax is the time to reach maximum plasma concentration.
Measured: Cycle 1 (each cycle is 28 days) Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start22 Sep 2020
- Primary completion23 Feb 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lupin Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dhanajay Bakhle, MD, Study chair, Lupin Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187858
- Sponsor's protocol ID
- LRP/LNP3794/2020/001
- Status last verified
- Mar 2023
- First submitted
- 8 Dec 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label Study of LNP3794 (BI3011441) in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT05187858
- Acronym / sponsor ID
- LRP/LNP3794/2020/001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lupin Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LNP3794 | Experimental | Drug: LNP3794Participants will receive LNP3794 orally once daily at different doses in 28 day cycles on a continuous basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNP3794LNP3794 capsules administered orally once daily | Drug | LNP3794 |
Primary outcome
Number of subjects with dose limiting toxicities (DLTs) at each dose level during the first cycle
Time frame: up to Day 28
Dose limiting toxicities will be evaluated through the first cycle (each cycle is 28 days)
7 secondary outcomes
Number of subjects with DLTs during the entire on-treatment period
Time frame: up to 2 years
Number of subjects with Grade ≥3 treatment-related adverse events (AEs)
Time frame: up to 2 years
Number of subjects with treatment-related AEs at each dose level
Time frame: up to 2 years
Maximum Plasma Concentration (Cmax) of LNP3794
Time frame: Cycle 1 (each cycle is 28 days) Day 1 and Day 14
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last])
Time frame: Cycle 1 (each cycle is 28 days) Day 1 and Day 14
Area under the concentration-time curve from time zero to the end of dosing interval (AUC[0-tau])
Time frame: Cycle 1 (each cycle is 28 days) Day 1 to 2 and Day 14 to 15
Time to maximum concentration (Tmax)
Time frame: Cycle 1 (each cycle is 28 days) Day 1 and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
Related trials for NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
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Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhanajay Bakhle, MD study chair
Lupin Limited
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LNP3794 in people with NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors, run by Lupin Ltd. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with dose limiting toxicities (DLTs) at each dose level during the first cycle (time frame: up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.