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A Phase 1b-2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients with Solid Tumors
EU CTIS ID: 2026-525629-20-00
What this study is testing
Identify an appropriate dose of LRK-4189 for initial expansion (active dose or maximum tolerated dose [MTD]), evaluate the preliminary efficacy of LRK-4189 in patients with metastatic colorectal cancer (mCRC) and determine the optimal dose of LRK-4189 in specific indications
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Able and willing to sign the informed consent form and consent with the protocol and the restrictions and assessments therein
- Evidence of adequate organ function at screening
- All previous anti-cancer therapy-related AEs (including peripheral neuropathy) should have resolved to Grade 1 or baseline value with the exception of alopecia and stable, treated endocrine toxicities of immune checkpoint inhibitors
- Female patients must be of non-child-bearing potential or if of child-bearing potential, must agree not to attempt to become pregnant, must not donate ova, and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method(s) of contraception from signing the consent form until at least 6 months after the last dose of study drug (9 months if receiving oxaliplatin)
- Male patients must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use a condom and their partner must be advised to also use a highly effective method of contraception from signing the consent form until at least 6 months after the last dose of study drug (9 months if receiving oxaliplatin)
- ≥18 years of age
You likely can't join if
- Unable due to concomitant treatment or variant anatomy to swallow or absorb LRK-4189 as an oral formulation
- Active infection requiring IV therapy. If receiving systemic oral antibiotics, patients must be afebrile for at least 3 days prior to dosing to be eligible
- Participants taking medications that are strong XXXX or XXXX or XXX that cannot be discontinued at least 14 days prior to initiating study treatment
- Therapeutic anticoagulation if it cannot be withheld to enable biopsies to be performed safely.
- History or clinical evidence of any surgical or medical condition which the Investigator or Medical Monitor judges as likely to interfere with the results of the study, poses an additional risk in participating, or makes the patient unlikely to comply with the study related visits and assessments, particularly any pre-existing condition that would put the patient at additional risk
- Unable to comply with the visits and requirements of the protocol due to psychiatric condition or substance abuse
See the full eligibility criteria
Who can join
- Able and willing to sign the informed consent form and consent with the protocol and the restrictions and assessments therein
- Evidence of adequate organ function at screening
- All previous anti-cancer therapy-related AEs (including peripheral neuropathy) should have resolved to Grade 1 or baseline value with the exception of alopecia and stable, treated endocrine toxicities of immune checkpoint inhibitors
- Female patients must be of non-child-bearing potential or if of child-bearing potential, must agree not to attempt to become pregnant, must not donate ova, and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method(s) of contraception from signing the consent form until at least 6 months after the last dose of study drug (9 months if receiving oxaliplatin)
- Male patients must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use a condom and their partner must be advised to also use a highly effective method of contraception from signing the consent form until at least 6 months after the last dose of study drug (9 months if receiving oxaliplatin)
- ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Must have a histologically proven locally advanced or metastatic inoperable tumor that has progressed on/after at least one line of prior therapy considered standard of care in the advanced/metastatic setting
- In the investigator’s opinion, the patient may not derive clinical benefit from, or is ineligible for, a particular form of standard therapy on medical grounds, or the patient failed or did not tolerate one or more other anti-cancer therapies
- RECIST 1.1 evaluable disease
- Provide a sufficient and adequate formalin-fixed paraffin-embedded (FFPE) tumor tissue sample (biopsy) collected after the last dose of prior systemic anti-cancer therapy and before the first dose of study treatment from a site not previously irradiated
- Agree to mandatory on-treatment biopsy (if clinically feasible at time of biopsy).
- QT interval corrected using the Fridericia method (QTcf) ≤ 480 msec
What rules you out
- Unable due to concomitant treatment or variant anatomy to swallow or absorb LRK-4189 as an oral formulation
- Active infection requiring IV therapy. If receiving systemic oral antibiotics, patients must be afebrile for at least 3 days prior to dosing to be eligible
- Participants taking medications that are strong XXXX or XXXX or XXX that cannot be discontinued at least 14 days prior to initiating study treatment
- Therapeutic anticoagulation if it cannot be withheld to enable biopsies to be performed safely.
- History or clinical evidence of any surgical or medical condition which the Investigator or Medical Monitor judges as likely to interfere with the results of the study, poses an additional risk in participating, or makes the patient unlikely to comply with the study related visits and assessments, particularly any pre-existing condition that would put the patient at additional risk
- Unable to comply with the visits and requirements of the protocol due to psychiatric condition or substance abuse
- Pregnant or breastfeeding or planning to conceive or father children within the projected duration of the study and subsequent 3 months
- Combination cohorts: contraindication to receive mFOLFOX6 or FOLFIRI, whichever is applicable
- Patients receiving capecitabine or fluorouracil: known history or positive test for DPD deficiency.
- Known hypersensitivity to LRK-4189 or any of its excipients
- Contraindication to serial biopsies
- Symptomatic ascites or pleural effusion requiring therapeutic thoraco- or paracentesis in the 6 weeks before treatment.
- Known active central nervous system metastases and/or carcinomatous meningitis; brain metastases requiring treatment with steroids
- For expansion phase only: presence of any other active malignancy requiring systemic therapy other than the disease under study
- Concurrent anti-cancer therapy
- Known active infection with human immunodeficiency virus, hepatitis B or hepatitis C, defined by a detectable viral load. Note: testing is not required for eligibility
- Use of systemic corticosteroids to treat inflammatory or autoimmune symptoms within 2 weeks or other immunosuppressive drugs within 30 days prior to the start of the study
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.