Phase 2 Study of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer
A Multi-Institutional Phase 2 Evaluation of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well daraxonrasib alone fights bile duct system cancer with a change in the KRAS gene. It is for adults whose cancer cannot be removed by surgery or has spread, and whose cancer got worse after their first drug treatment or who could not tolerate that treatment.
The purpose of this study is to evaluate the anti-tumor efficacy of daraxonrasib monotherapy in patients with unresectable or advanced/metastatic, KRAS-mutant BTC who have progressed on or are intolerant of 1st line systemic therapy.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, with bile duct system cancer confirmed by tissue or cell tests that cannot be removed by surgery or has spread.
- Have a confirmed KRAS gene change and cancer that can be measured on scans.
- Have cancer that got worse after one prior chemotherapy treatment plan, with or without immune therapy, or be unable to tolerate that treatment.
- Be fully active or able to do light work despite some limits on hard physical activity.
- Have blood tests showing that your organs and bone marrow work well enough.
- Agree to give tissue and blood samples several times for research.
- If able to become pregnant, have a negative pregnancy test; otherwise, show that menopause has occurred. All participants must agree to use accepted birth control during the study.
- Be able to take medicine by mouth, keep a daily medicine diary, understand the study and its risks, and sign a consent form.
Who can't join
- Had cancer drug treatment too recently: within 3 weeks before joining, or the time for most of the drug to leave your body, whichever is shorter. Prior drugs targeting KRAS, RTK, MEK, or related RAS signals are also not allowed.
- Had major surgery, wide-area radiation, or treatment to a local region within 4 weeks before the first dose; had small-area radiation within 2 weeks; or have not recovered from earlier treatment side effects.
- Have another cancer that is growing and needs treatment, or take medicines that interfere with daraxonrasib.
- Have serious heart disease or heart electrical signal problems, poor stomach or bowel function, an active disease where the immune system attacks the body, or active fluid buildup in the belly.
- Have an uncontrolled infection needing whole-body treatment within 72 hours before the first dose, a history of HIV, or active or long-term hepatitis B or C.
- Have a history of cancer spread to the brain or spinal cord, uncontrolled seizures, or another uncontrolled illness.
- Are pregnant or breastfeeding, or cannot or will not follow the study schedule. Mental health or substance use problems that prevent cooperation also rule out joining.
- Have any condition, treatment, or test result that the study doctor believes could affect the results, prevent full participation, or make joining not in your best interest.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Unresectable locally advanced or metastatic histologically or cytologically confirmed biliary tract cancer * Must have documented disease progression or intolerance of one prior systemic chemotherapy regimen (with or without immunotherapy) for unresectable and/or advanced stage disease. * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1. * Have measurable disease based on RECIST 1.1. * Documented KRAS mutation * Adequate organ and marrow function defined by study-specified laboratory tests and procedures. * Willingness to provide serial tissue and blood samples for mandatory translational research. * Evidence of post-menopausal status or a negative pregnancy test in women of childbearing potential (WOCBP). * All participants must agree to use acceptable form of birth control while on study. * Ability to take oral medications and willingness to keep daily adherence record in a medication diary. * Must understand the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form in accordance with regulatory and institutional guidelines. Exclusion Criteria: * Any systemic anti-cancer therapy for advanced BTC within 3 weeks of enrollment or 5 half-lives of the drug, whichever is shorter. * Prior treatment with any KRAS, RTK, or MEK inhibitor or other RAS-pathway targeting signal transduction inhibitor agents * Major surgery, extended field radiotherapy, or local regional therapy within 4 weeks from first dose of study drug, limited field radiotherapy within 2 weeks of first dose, or failure to recover from side effects of these prior therapies * Known additional malignancy that is progressing and requires active treatment. * Receiving concomitant medications that interfere with Daraxonrasib. * Significant cardiovascular disease. * Significant cardiac conduction abnormalities. * Impaired gastrointestinal function. * Active autoimmune disease * Clinically active ascites. * Active uncontrolled infection requiring systemic therapy within 72 hours prior to C1D1. * Known history of human immunodeficiency virus (HIV). * Active or chronic hepatitis B or hepatitis C. * Known history of central nervous system (CNS) metastases and/or history of uncontrolled seizures. * Any uncontrolled acute or chronic medical illness. * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Pregnant or breastfeeding * Patient is unwilling or unable to follow the study schedule for any reason. * Has known psychiatric or substance use disorder that would interfere with cooperation with the requirements of the trial.
Study sites (1)
MD
- Sidney Kimmel Comprehensive Cancer Center · Baltimore, MD 21231More trials in Baltimore