NeoplasmsPhase 1/2NCT07498725
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors
A Phase 1/2 study testing LRK-4189 escalation, LRK-4189 expansion and LRK-4189 optimization in people with Neoplasms, run by LARKSPUR BIOSCIENCES, INC. at 3 sites in 2 countries.
Trial summary
The goal of this clinical trial is to learn if investigational agent LRK-4189 works to treat solid tumors in adults, with a focus on colorectal cancer. It will also learn about the safety of drug LRK-4189. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- LRK-4189 escalation, LRK-4189 expansion and LRK-4189 optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 7 Jul 2026to Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Willing and able to sign the study consent form and take part in all required study visits, tests, and procedures.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Have a locally advanced or metastatic cancer that cannot be removed with surgery and has gotten worse despite treatment.
- Cancer can be measured on scans, such as CT or MRI.
- Willing to have tumor biopsies, meaning small samples of your tumor will be collected during the study.
- Heart rhythm test (ECG) shows a normal result within safe limits.
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- Blood test results at screening are within an acceptable and stable range.
- If you are a woman, you are not able to become pregnant, or you agree not to become pregnant during the study and to use approved birth control methods.
- If you are a man, you agree not to donate sperm during the study. If you have sex with a partner who could become pregnant, you agree to use approved birth control methods during the study.
Who cannot join
- Unable to swallow the study medication or your body cannot absorb it.
- Have had a serious allergic reaction to LRK-4189 or any of its ingredients.
- Have needed a fluid drainage procedure from the chest or abdomen within the past 6 weeks.
- Have active cancer in the brain or spinal fluid, or brain tumors that require steroid treatment.
- Currently receiving another cancer treatment.
- Have an active HIV, hepatitis B, or hepatitis C infection with detectable virus levels.
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- Have an active infection that requires treatment through a vein (IV).
- Taking certain medications that strongly interact with the study drug and cannot stop them at least 14 days before starting the study.
- Pregnant or breastfeeding or planning to become pregnant or father a child during the study.
- Cannot safely receive the standard chemotherapy that would be used with this study.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
France2 sites, 2 recruiting
- Recruiting
Centre Antoine Lacassagne
Nice
Sr. Director, Program Management, 6176931232, clinicaltrials@larkspur.bio
- Recruiting
Hopitaux Universitaires de Strasbourg
Strasbourg
Sr. Director, Program Management, 6176931232, clinicaltrials@larkspur.bio
United Kingdom1 site, 1 recruiting
- Recruiting
Western General Hospital
Edinburgh
Sr. Director, Program Management, 6176931232, clinicaltrials@larkspur.bio
About this study
Official title: A Phase 1b-2, Open-Label, Dose-Escalation, Expansion and Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of LRK-4189 Alone and in Combination With mFOLFOX6 or FOLFIRI in Patients With Solid Tumors
The goal of this clinical trial is to learn if investigational agent LRK-4189 works to treat solid tumors in adults, with a focus on colorectal cancer. It will also learn about the safety of drug LRK-4189.
The main questions it aims to answer are:
Is LRK-4189, administered alone or in combination with standard chemotherapy regimens, safe and tolerable in patients with solid tumors?
Participants will:
- Take investigational agent LRK-4189 alone or in combination with standard chemotherapy regimens every day for up to 3 years.
- Visit the clinic once every week for checkups and tests.
- Conditions
- Neoplasms
- Being tested
- LRK-4189 escalation, LRK-4189 expansion, LRK-4189 optimization, Chemo
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LRK-4189 escalationDrug
LRK-4189 at various doses
LRK-4189 expansionDrug
LRK-4189 MTD
LRK-4189 optimizationDrug
LRK-4189 2 distinct doses
ChemoDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Part 1/1b escalation | Experimental | Not described Receives: Drug: LRK-4189 escalation |
| Part 2 expansion | Experimental | Not described Receives: Drug: LRK-4189 expansion |
| Part 2b expansion | Experimental | Not described Receives: Drug: LRK-4189 expansion; Drug: Chemo |
| Part 3 optimization | Experimental | Not described Receives: Drug: LRK-4189 optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of treatment-related adverse events and/or toxicity, presented by dose, regimen and tumor type
Measured: From enrollment to the end of the first treatment cycle (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start7 Jul 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LARKSPUR BIOSCIENCES, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498725
- Sponsor's protocol ID
- LRK-4189-102
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b-2, Open-Label, Dose-Escalation, Expansion and Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of LRK-4189 Alone and in Combination With mFOLFOX6 or FOLFIRI in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07498725
- Acronym / sponsor ID
- LRK-4189-102
- Conditions
- Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- LARKSPUR BIOSCIENCES, INC.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 27 Mar 2026 (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.
The goal of this clinical trial is to learn if investigational agent LRK-4189 works to treat solid tumors in adults, with a focus on colorectal cancer. It will also learn about the safety of drug LRK-4189.
The main questions it aims to answer are:
Is LRK-4189, administered alone or in combination with standard chemotherapy regimens, safe and tolerable in patients with solid tumors?
Participants will:
- Take investigational agent LRK-4189 alone or in combination with standard chemotherapy regimens every day for up to 3 years.
- Visit the clinic once every week for checkups and tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1/1b escalation | Experimental | Drug: LRK-4189 escalation |
| Part 2 expansion | Experimental | Drug: LRK-4189 expansion |
| Part 2b expansion | Experimental | Drug: LRK-4189 expansion, Drug: Chemo |
| Part 3 optimization | Experimental | Drug: LRK-4189 optimization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to sign the study consent form and take part in all required study visits, tests, and procedures.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Have a locally advanced or metastatic cancer that cannot be removed with surgery and has gotten worse despite treatment.
- Cancer can be measured on scans, such as CT or MRI.
- Willing to have tumor biopsies, meaning small samples of your tumor will be collected during the study.
Key exclusion criteria (10 listed)
- Unable to swallow the study medication or your body cannot absorb it.
- Have had a serious allergic reaction to LRK-4189 or any of its ingredients.
- Have needed a fluid drainage procedure from the chest or abdomen within the past 6 weeks.
- Have active cancer in the brain or spinal fluid, or brain tumors that require steroid treatment.
- Currently receiving another cancer treatment.
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 |
|---|---|---|
| LRK-4189 escalationLRK-4189 at various doses | Drug | Part 1/1b escalation |
| LRK-4189 expansionLRK-4189 MTD | Drug | Part 2 expansion, Part 2b expansion |
| LRK-4189 optimizationLRK-4189 2 distinct doses | Drug | Part 3 optimization |
| ChemoStandard of care | Drug | Part 2b expansion |
Primary outcome
Evaluation of treatment-related adverse events and/or toxicity, presented by dose, regimen and tumor type
Time frame: From enrollment to the end of the first treatment cycle (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LRK-4189 escalation, LRK-4189 expansion and LRK-4189 optimization in people with Neoplasms, run by LARKSPUR BIOSCIENCES, INC. at 3 sites in 2 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 9 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, United Kingdom. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CEO (6176931232, trialinfo@larkspur.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of treatment-related adverse events and/or toxicity, presented by dose, regimen and tumor type (time frame: From enrollment to the end of the first treatment cycle (each cycle is 21 days)). 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 13 Jul 2026.