Neoplasms
Conditions
Brief 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. 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.
Interventions
DRUGLRK-4189 escalation
LRK-4189 at various doses
DRUGLRK-4189 expansion
LRK-4189 MTD
DRUGLRK-4189 optimization
LRK-4189 2 distinct doses
DRUGChemo
Standard of care
Sponsors
LARKSPUR BIOSCIENCES, INC.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of treatment-related adverse events and/or toxicity, presented by dose, regimen and tumor type | From enrollment to the end of the first treatment cycle (each cycle is 21 days) |
Countries
France, United Kingdom
Contacts
CONTACTCEO
Outcome results
None listed