BridgeMD
New treatment option for Breast Cancer
Official title VS-6766+Abema+Fulv in Met HR+/HER- BC
ClinicalTrials.gov ID: NCT05608252
What this study is testing
What is VS-6766?
VS-6766 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for breast cancer.
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
- This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer. The names of the study drugs involved in this study are: VS-6766 Abemaciclib Fulvestrant
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically or cytologically confirmed hormone receptor positive (HR+), HER2 negative metastatic or locally recurrent...
- Participants may have measurable or non-measurable disease according to RECIST v1.1.
- Men and pre- and postmenopausal women are eligible. Ongoing monthly GNRH agonist is required in pre-menopausal women or male participants for at...
- Participants must have radiological or objective evidence of progression on any CDK 4/6 inhibitor-containing regimen in the metastatic setting...
- It is not mandatory to have a CDK4/6 inhibitor-containing regimen as the most recent treatment.
You likely can't join if
- Participants with active brain metastases or with known carcinomatous meningitis. Stable, treated brain metastases are allowed (this includes...
- Phase I: Participants who have discontinued prior abemaciclib for toxicity, at any dose. Phase II: Participants who have discontinued prior...
- Participants who have discontinued prior fulvestrant for toxicity.
- Prior treatment with any MEK inhibitor.
- The subject has received another investigational agent within at least 30 days or 5 half-lives of the first dose of study drug, whichever is longer...
- The subject has received a chemotherapy agent or immunotherapy within 21 days of the first dose of study drug.
See the full eligibility criteria
Who can join
- Participants must have histologically or cytologically confirmed hormone receptor positive (HR+), HER2 negative metastatic or locally recurrent unresectable invasive breast cancer. ER, PR and HER2 measurements should be...
- Participants may have measurable or non-measurable disease according to RECIST v1.1.
- Men and pre- and postmenopausal women are eligible. Ongoing monthly GNRH agonist is required in pre-menopausal women or male participants for at least 4 weeks prior to study entry. If men or pre-menopausal women have...
- Participants must have radiological or objective evidence of progression on any CDK 4/6 inhibitor-containing regimen in the metastatic setting, and/or relapse/progression during or within 12 months of completion of any...
- It is not mandatory to have a CDK4/6 inhibitor-containing regimen as the most recent treatment.
- Participants must have radiological or objective evidence of progression on fulvestrant (as a single agent or as a component of any multi-drug regimen) in the metastatic setting.
- It is not mandatory to have a fulvestrant-containing regimen as the most recent treatment.
- Prior therapy:
- No more than two prior chemotherapy regimens in the metastatic setting.
- For both the phase I and phase II portions of this trial, there is no limit on prior lines of endocrine therapy in the adjuvant or metastatic setting.
- For phase 2 cohort only: Willing to undergo pre- and on-treatment tumor biopsies. Patients are exempt from this requirement if, in the opinion of the investigator, the biopsy procedure would pose a significant risk...
- ECOG performance status \<2.
- Participants must have normal organ and marrow function as defined below:
- absolute neutrophil count ≥ 1.5 x 109/L
- platelets ≥100,000/μl
- hemoglobin ≥9 g/dL (If red blood cell transfusion has been administered, hemoglobin must remain stable and ≥9 g/dL without further transfusion for at least 1 week prior to first dose of study therapy).
- total bilirubin ≤1.5mg/dL (≤3.0mg/dL in patients with known Gilbert syndrome and direct bilirubin within normal limits)
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN.
- Adequate renal function with a creatinine clearance rate of ≥ 50 mL/min as calculated by the Cockcroft-Gault formula.
- International normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) ≤ 1.5 x ULN in the absence of anticoagulation or therapeutic levels in the presence of anticoagulation.
- Creatine phosphokinase (CPK) ≤ 2.5 x ULN.
- Adequate cardiac function with left ventricular ejection fraction ≥ 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.
- Baseline QTc interval \< 480 ms (average of triplicate readings) using Fredericia's QT correction formula. NOTE: This criterion does not apply to patients with a complete or incomplete right or left bundle branch block.
- Adequate recovery from toxicities related to prior systemic treatments, surgery, or radiotherapy to at least Grade 1 by CTCAE v 5.0. Exceptions include alopecia and peripheral neuropathy grade ≤ 2.
- Age \>18 years. Because no dosing or adverse event data are currently available on the use of study agents in participants \<18 years of age, children are excluded from this study.
- Women of childbearing potential, women who are made postmenopausal through use of GNRH agonists, and men must agree to use adequate contraception for the duration of protocol treatment. Women meeting these criteria will...
- True abstinence when this is in line with the preferred and usual lifestyle of the participant. [Periodic abstinence (e.g., calendar, ovulation, symptothermal post-ovulation methods) and withdrawal are not acceptable...
- Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female participants, the vasectomized male partner should be the sole partner. OR Effective Non-Hormonal...
- Placement of non-hormonal or progesterone-coated intrauterine device (IUD) or intrauterine system (IUS). Consideration should be given to the type of device being used, as there are higher failure rates quoted for...
- Condom with spermicidal foam/gel/film/cream/suppository.
- Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- The use of barrier contraceptives should always be supplemented with the use of spermicide. The following should be noted:
- Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore, the use of additional spermicides does confer additional theoretical contraceptive...
- However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled. Therefore, spermicides are not a barrier method of contraception and should not be used alone. It should be noted...
- A female of childbearing potential, as defined above in section 3.1.12, must have a negative serum pregnancy test performed within 7 days of C1D1. A positive urine test must be confirmed by a serum test. Pregnancy...
- Age \>60 years; or
- Age \<60 years with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or
- Status post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation
- Participant must be able to swallow and retain oral medication.
- Ability to understand and willingness to sign a written informed consent document
What rules you out
- Participants with active brain metastases or with known carcinomatous meningitis. Stable, treated brain metastases are allowed (this includes participants who have documented radiologic stability at least 4 weeks after...
- Phase I: Participants who have discontinued prior abemaciclib for toxicity, at any dose. Phase II: Participants who have discontinued prior abemaciclib for toxicity, if that toxicity occurred at or above the RP2 dose...
- Participants who have discontinued prior fulvestrant for toxicity.
- Prior treatment with any MEK inhibitor.
- The subject has received another investigational agent within at least 30 days or 5 half-lives of the first dose of study drug, whichever is longer, or is currently enrolled in any medical device research or other...
- The subject has received a chemotherapy agent or immunotherapy within 21 days of the first dose of study drug.
- The subject has received an endocrine or biologic agent within 14 days of the first dose of study drug.
- The subject has completed radiation within 14 days of registration. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy.
- The subject has had major surgery within 14 days of registration.
- Participants with the following pre-existing ocular pathology are excluded:
- Patients with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes.
- Patient with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \> 21 mm Hg as measured by tonometry, or other significant ocular...
- Patients with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions.
- History of rhabdomyolysis or neuromuscular disorders that are associated with elevated CK (eg inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
- The patient has an uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure (New York Heart...
- Individuals with a history of a second malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are potentially eligible if they have been disease-free for at...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to VS-6766 (including inactive ingredients mannitol, magnesium stearate, HPMC (hydroxypropylmethylcellulose) shells)...
- Known history of testing positive for HIV with history of an AIDS-defining opportunistic infection within the past 12 months, or need to receive combination antiretroviral therapy for HIV that are strong CYP3A4...
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (for example, hepatitis B surface antigen positive). Screening is not required for enrollment. Patients with chronic HBV infection who meet...
- Patients exposed to strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose of study drugs (see Appendix C). Concurrent use of strong CYP3A4 inhibitors (see Appendix C), such as ketoconazole and...
- Pregnant women are excluded from this study because effect of combination VS-766, abemaciclib, and fulvestrant on a developing fetus is unknown. Breastfeeding should be discontinued prior to entry onto the study.
- Patients with the inability to swallow oral medications, impaired gastrointestinal absorption due to gastrectomy or other major surgical resection involving the stomach or small bowel, preexisting Crohn's disease or...
- Patients with active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), or fungal infection (requiring IV antifungal treatment at time of initiating study...
- Patients on treatment with warfarin. Individuals on treatment with warfarin must be transitioned to anticoagulation instead with low-molecular-weight heparin or a direct oral anticoagulant prior to first dose of study...
- Any other serious and/or uncontrolled preexisting medical condition(s) (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, other cardiac, gastrointestinal, pulmonary, psychiatric...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. 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.