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ZB716 + Palbociclib for Breast Cancer (ENZENO Trial)
ENZENO Trial Summary
This trial is studying a new drug, ZB716, to see if it is safe and tolerable in people with ER-positive, HER2-negative advanced breast cancer. The trial will also look at the pharmacokinetics, or how the body processes the drug, and pharmacodynamics, or how the drug affects the body, of ZB716.
ENZENO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 55 Patients • NCT03007979ENZENO Trial Design
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Who is running the clinical trial?
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- You have a current infection that needs antiviral treatment or have tested positive for hepatitis B or hepatitis C.You were diagnosed with another type of cancer within 3 years before joining the study, except for certain specific conditions.You are currently taking warfarin or phenytoin.You have the hepatitis B core antibody, but you also need to have the hepatitis B surface antibody and a negative HBV DNA test to be eligible.You have taken other cancer medicines within the last 4 weeks, or within 5 times the duration it takes for those medicines to leave your body, before starting this study.You have been diagnosed with adenocarcinoma of the breast through a tissue sample.You have a serious liver disease or active viral hepatitis.You have a condition that affects your digestion or absorption of medication, such as chronic diarrhea or previous major stomach surgery.If you have a positive test for hepatitis C, you can only participate if a follow-up test for hepatitis C virus is negative.Your tumor cells have a certain protein called ER that can be seen with a special test.If the main tumor is sensitive to estrogen and any other tumors are not sensitive to estrogen, you cannot be included in the study.You have cancer that has spread and cannot be treated with radiation or surgery to cure it.
- Group 1: Part A: Dose Escalation of ZB716 monotherapy (with Food Effect Cohort)
- Group 2: Part C: Dose Escalation of ZB716 in combination with palbociclib
- Group 3: Part D: Dose Expansion of ZB716 in combination with palbociclib
- Group 4: Part B: Dose Expansion of ZB716 monotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any appointments available for this clinical trial?
"Correct, the clinicaltrials.gov website has information about this active study which was posted on 7/26/2021 and last updated on 3/20/2022. They are currently recruiting 106 participants from 1 site."
What does this trial hope to achieve for patients?
"The success of this study will be determined by the rate of disease progression in patients, which will be monitored over a 6-month period. Additionally, we will measure the maximum concentration (Cmax) and total area under the curve (AUC) of ZB716 and palbociclib."
What ailments or conditions is ZB716 most often effective in treating?
"ZB716 is most commonly used to treat breast cancer, but it has shown efficacy against other conditions like malignant neoplasms, postmenopause, and advance directives."
Are there any other notable case studies that have used ZB716?
"At present, ZB716 is being investigated in 139 different clinical trials. Of these active studies, 17 have reached Phase 3 testing. The majority of research locations for ZB716 are located in Burgas, New jersey; however, there are a total of 6640 sites running this investigation worldwide."
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