Phase 1 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are an adult with advanced or spreading breast cancer that is either estrogen receptor-positive/HER2-negative (ER+/HER2-), or a specific type of triple-negative breast cancer that tests positive for androgen receptors (at least 10% by a lab test), depending on which part of the study you are enrolling in.
• You have already received standard treatments for your type of breast cancer, which for ER+/HER2- disease includes hormone therapy combined with a CDK4/6 inhibitor.
• Your cancer can be measured on scans according to standard criteria (called RECIST v1.1), unless you are joining a specific early part of the study (Part 1A).
• Depending on which part of the study you join, your tumor may need to show either the absence of a specific gene change called an ESR1 mutation (Part 2A), or the presence of a specific gene change called FGFR1 amplification (Part 2B), based on previous testing.
• You are able to provide a stored or newly collected tumor tissue sample for testing as required by the study.
• You are generally well enough to carry out light activity and care for yourself — scored 0 or 1 on a standard health scale called ECOG.
• Your blood counts, liver, kidney, and clotting functions are within acceptable levels based on lab tests.
• Your doctors estimate you have a life expectancy of at least 12 weeks.
• You are able to swallow tablets or capsules and are willing and able to give written consent to take part.

Who may not be able to join:

• You have previously been treated with a drug that targets or breaks down a protein called Kinesin.
• You have a known allergy or sensitivity to any of the study drugs or their ingredients.
• You have received cancer treatment too recently (within specific time periods set out by the study).
• You have another active cancer that could affect how the study results are assessed.
• You have a certain type of heart rhythm abnormality — specifically a QTcF measurement greater than 470 milliseconds on a heart tracing, or a condition called congenital long QT syndrome.
• You have had a significant blood clot in the lungs within the 6 weeks before starting the study.
• You have had major surgery within the last 4 weeks, or minor surgery within the last 2 weeks before starting the study.
• You have an active infection that requires treatment with medicines given by injection or drip (systemic therapy) within 2 weeks before starting the study.
• You are pregnant, breastfeeding, or planning to become pregnant, father a child, or donate eggs or sperm during the study or for a required period after treatment ends.
• You have previously had an organ transplant or a bone marrow transplant from a donor, with some possible exceptions (confirm with trial site).
• You are still experiencing side effects from previous cancer treatment that have not recovered to a mild or baseline level, with some specific exceptions (confirm with trial site).
• You have any serious or uncontrolled medical, mental health, or laboratory condition that could affect your safety or the reliability of the study results.
• There may be additional reasons you cannot join as set out in the full study document (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.