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Selective Estrogen Receptor Degrader
ZB716 + Palbociclib for Breast Cancer (ENZENO Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by EnhancedBio USA Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after last dose of zb716 or zb716 with palbociclib
Awards & highlights
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.
Who is the study for?
This trial is for adults with ER-positive, HER2-negative advanced breast cancer. Participants must understand the study and consent to it. They should have a confirmed diagnosis, no active infections requiring antiviral therapy, no other cancers in the last 3 years (with some exceptions), and not be on certain medications like warfarin or phenytoin.Check my eligibility
What is being tested?
The ENZENO Study tests ZB716, an oral drug expected to block estrogen receptors better than current treatments. It's given alone or with Palbociclib to see how safe it is and how well patients tolerate it. The study also looks at how food affects ZB716 absorption and its impact on tumor markers and response rates.See study design
What are the potential side effects?
Since this is the first time ZB716 will be used in humans, specific side effects are unknown but may include typical reactions related to hormone therapies such as hot flashes, fatigue, nausea, and potential blood clots. Palbociclib can cause low white blood cell counts increasing infection risk.
ENZENO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after last dose of zb716 or zb716 with palbociclib
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after last dose of zb716 or zb716 with palbociclib
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: To determine the RD(Recommended Dose) of ZB716
Part B: To assess antitumor activities at the ZB716 RD in monotherapy
Part C: To determine the RD of ZB716 in combination with palbociclib
+1 moreSecondary outcome measures
AUC0-24 of Palbociclib after repeated dose (Part C and D)
AUC0-24 of Palbociclib after single dose (Part C and D)
AUC0-24 of ZB716 after repeated dose (Part A, B, C and D)
+13 moreSide effects data
From 2023 Phase 2 trial • 55 Patients • NCT0300797996%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Anorexia
35%
Hyponatremia
35%
Cough
35%
Arthralgia
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hyperkalemia
31%
Hypercalcemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Hyperglycemia
20%
Dysgeusia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Peripheral sensory neuropathy
17%
Sinusitis
17%
Upper respiratory infection
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Hyperhidrosis
13%
Urinary tract infection
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Epistaxis
9%
Hypophosphatemia
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Tooth infection
7%
Non-cardiac chest pain
7%
Skin infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Death
6%
Cellulitis
6%
Cataract
6%
Itchy skin
6%
Dehydration
6%
Knee pain
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Vaginal dryness
4%
Watering eyes
4%
Burn
4%
Flu-like symptoms
4%
Edema trunk
4%
Back spasms
4%
Dry eye
4%
Sinus pain
4%
Head injury
4%
Memory impairment
4%
Skin bump
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Broken tooth
4%
Abdominal pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Bilateral nares sores
2%
Puncture wound
2%
Cold sweats
2%
Localized edema
2%
Wrist fracture
2%
Activated partial thromboplastin time prolonged
2%
Lung cancer
2%
Vaginal discharge
2%
Erythema multiforme
2%
Erythema right breast
2%
Paronychia
2%
Vaginal infection
2%
COPD
2%
Sinus congestion
2%
Sinus tachycardia
2%
Diverticulitis
2%
Sepsis
2%
Hyperuricemia
2%
Facial nerve disorder
2%
Paresthesia
2%
Agitation
2%
Urinary retention
2%
Oral fissure
2%
Eye lid pain
2%
Pharyngitis
2%
Blood bilirubin increased
2%
Flank pain
2%
Cognitive disturbance
2%
Radiation recall reaction (dermatologic)
2%
Photophobia
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
Fracture
2%
Vaginal itching
2%
Fever blister
2%
Hemorrhoids
2%
Yeast infection
2%
Intrascapular pain
2%
Wrist pain
2%
Hoarseness
2%
Laryngeal inflammation
2%
Leg pain
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Hypermagnesemia
2%
Urine discoloration
2%
Nail loss
2%
Shoulder nodule
2%
Peeling lips
2%
Vaginal itch
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Peeling skin palms of hands
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
C. difficile
2%
Gait disturbance
2%
Myocardial infarction
2%
Red eye
2%
Groin pain
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Blister
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant
ENZENO Trial Design
4Treatment groups
Experimental Treatment
Group I: Part D: Dose Expansion of ZB716 in combination with palbociclibExperimental Treatment2 Interventions
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Subjects will come to the clinical site before the first dose of study drug to confirm eligibility. Cohorts will be enrolled sequentially based on an optional Simon 2-stage study design.
Approx. 29 subjects may be enrolled in the dose expansion cohorts of Part D. For Part D, doses will be administered (self-administered by subjects at home or administered by subjects under observation of clinical staff during clinic visits) at the determined RD of ZB716 QD for 28 days from Part C in combination with the standard dose of Palbociclib (125 mg QD for 21 days with 7 days off treatment). Doses will be administered in the dietary status for dosing as determined from Part A fed/fasted comparison.
Group II: Part C: Dose Escalation of ZB716 in combination with palbociclibExperimental Treatment2 Interventions
Cohorts will follow a 3+3 study design. Approx. 6 to 12 subjects will be enrolled in the dose escalation phase of ZB716 in combination with Palbociclib. For Part C, doses will be administered at escalating doses starting with 1 dose level below the monotherapy RD (determined in Part A) and Palbociclib will be dosed at the fixed standard dose of 125 mg QD. ZB716 will be administered on a 28 day cycle and Palbociclib will be administered for 21 days in the cycle with 7 days off treatment. Administration of the higher dose level (at monotherapy RD) of ZB716 (with the standard dose of Palbociclib) to subsequent subjects will be based on the occurrence of DLTs during the DLT observation period (Cycle 1), until MAD of ZB716 with combination of Palbociclib is reached. Doses will be administered in the dietary status for dosing as determined from Part A fed/fasted comparison.
Group III: Part B: Dose Expansion of ZB716 monotherapyExperimental Treatment1 Intervention
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Subjects will come to the clinical site before the first dose of study drug to confirm eligibility. Cohorts will be enrolled sequentially based on an optional Simon 2-stage study design.
Approx. 29 subjects may be enrolled in the dose expansion cohorts of Part B. For Part B, doses will be administered (self-administered by subjects at home or administered by subjects under observation of clinical staff during clinic visits) at the determined monotherapy RD of ZB716 (based on Part A) QD in a 28-day cycle. Doses will be administered in the dietary status for dosing as determined from Part A fed/fasted comparison.
Group IV: Part A: Dose Escalation of ZB716 monotherapy (with Food Effect Cohort)Experimental Treatment1 Intervention
Cohorts will follow a 3+3 study design. Approx. 3 to 6 subjects will be enrolled in each dose cohort (6 subjects in Cohort A6; food-effect evaluation). (Dose levels: 50, 100, 200, 300, 400 mg, orally QD in a 28 day cycle) The overall DLT observation period of ZB716 monotherapy will be 4 weeks following the initial dose of study drug on Cycle 1 Day 1. There will be 2 ~ 6 days between dose escalations to allow sufficient time for an adequate safety review. The max. dose may be lower than 400 mg. In the first dosing group of Part A (Cohort A1), subject dosing will be staggered such that administration of the first dose is separated by at least 7 days between the first 2 subjects. In each of Cohorts A1 to A5, 3 to 6 subjects will receive ZB716 doses according to the assigned dose level in the fasted state. For Cohort A6, Period 1, doses will be administered in the fasted state in Treatment Period 1 and 2, doses will be given 30 min. after starting a standard high fat breakfast.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
EnhancedBio USA Inc.Lead Sponsor
ZenopharmUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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