BridgeMD
New treatment option for Advanced Solid Tumor
Official title Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04855656
What this study is testing
What is Lunresertib?
Lunresertib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Male or female and ≥12 years-of-age at the time of informed consent.
- Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients \>16 years of age.
- Locally advanced or metastatic resistant or refractory solid tumors.
- Patients \<18 years of age must weigh at least 40 kg.
- Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible
You likely can't join if
- Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half-lives, whichever is shorter, prior to first dose of study drug.
- History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation...
- Patients who are pregnant or breastfeeding.
- Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's...
- Major surgery within 4 weeks prior to first dose of lunresertib.
- Uncontrolled, symptomatic brain metastases.
See the full eligibility criteria
- Male or female and ≥12 years-of-age at the time of informed consent.
- Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients \>16 years of age.
- Locally advanced or metastatic resistant or refractory solid tumors.
- Patients \<18 years of age must weigh at least 40 kg.
- Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible
- Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker.
- CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH
- FBXW7 deleterious mutations identified by either a tumor or plasma NGS test
- PPP2R1A deleterious mutations identified by either a tumor or plasma NGS test
- Measurable disease as per RECIST v1.1. For certain modules, patients with prostate cancer or ovarian cancer that have non-measurable disease but have elevated tumor markers (PSA or CA-125, respectively) can also be...
- Ability to swallow and retain oral medications.
- Acceptable hematologic and organ function at screening.
- Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.
- Resolution of all toxicities of prior therapy or surgical procedures.
- Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment.
- Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half-lives, whichever is shorter, prior to first dose of study drug.
- History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.
- Patients who are pregnant or breastfeeding.
- Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
- Major surgery within 4 weeks prior to first dose of lunresertib.
- Uncontrolled, symptomatic brain metastases.
- Uncontrolled hypertension.
- Certain prior anti-cancer therapy
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New Hyde Park, New York, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Charlottesville, Virginia, United States
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Copenhagen, Denmark
- London, 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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States and 13 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.