Estrogen Receptor-PositivePhase 1/2ENZENONCT04669587
ER+/HER2- Locally Advanced or Metastatic Breast Cancer (ENZENO Study)
A Phase 1/2 study testing ZB716 and Palbociclib in people with Estrogen Receptor-Positive and HER2-Negative, run by EnhancedBio USA Inc. at 8 sites in 2 countries.
Trial summary
For patients with ER-positive, HER2-negative breast cancer, blockage of the ER pathway has been proven to be an effective anticancer approach. These patients showed good response to endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Estrogen Receptor-Positive, HER2-Negative, Locally Advanced Breast Cancer
- What is being tested?
- ZB716 and Palbociclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 26 Jul 2021to 31 Jan 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
[Inclusion Criteria]
Subjects must satisfy all of the following criteria for study entry:
- Subjects must be able to understand the nature of the trial and provide a signed and dated, written informed consent form (ICF) prior to any study-specific procedures, sampling, and analyses.
- Subjects aged ≥18 years old at time of signing ICF (or country's legal age of majority if the legal age is >18 years).
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast.
- Subjects with evidence of either locally advanced disease not amenable to radiation therapy or surgery in a curative intent, or metastatic disease.
- ER-positive tumor (≥1% positive stained cells) based on most recent tumor cell staining by immunohistochemistry (IHC) assay consistent with local standards.
Note: If primary tumor is ER-positive and any further metastatic lesions are ER negative, the subject cannot be selected for inclusion.
[Exclusion Criteria]
Subjects who meet any of the following criteria will be excluded from study entry:
- Treatment with any systemic anticancer therapies for locally advanced or metastatic breast cancer within 4 weeks or 5 half-lives of prior anticancer therapy, whichever is shorter, prior to initiation of study treatment.
- Concurrent treatment with warfarin or phenytoin.
- Diagnosis of any secondary malignancy within 3 years prior to enrollment, except for all intraepithelial neoplasia, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer.
- Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, major upper gastrointestinal (GI) surgery including gastric resection, or any other condition that may affect absorption of oral study drug.
- Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (eg, hepatitis B or hepatitis C virus), current alcohol abuse, or cirrhosis. Active viral or positive test for viral hepatitis as defined below:
Note: If reports of serology test for HBV and HCV containing normal ranges issued by formal medical institutions within 28 days prior to C1D1 (and prior to informed consent) are available, these tests are exempt while screening. Unless required by local regulations, patients are not required to have HIV assessments at screening.
Active infection is defined as requiring treatment with antiviral therapy or presence of positive test results for hepatitis B (hepatitis B surface antigen [HBsAg] and/or total hepatitis B core antibody [HBcAb]) or HCV antibody.
Patients who test positive for HBcAb are eligible only if test results are also positive for hepatitis B surface antibody and polymerase chain reaction is negative for HBV DNA.
Patients who are positive for HCV serology are only eligible if testing for HCV RNA is negative.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
South Korea7 sites, 7 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Keun Seok Lee
Keun Seok Lee
- Recruiting
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496
Yong Wha Moon
Yong Wha Moon
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Kyong Hwa Park
Kyong Hwa Park
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
Yun-Gyoo Lee
Yun-Gyoo Lee
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Joohyuk Sohn
Joohyuk Sohn
- Recruiting
Asan Medical Center
Seoul, 05505
Sung-Bae Kim
Sung-Bae Kim
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Jieun Lee
Jieun Lee
United States1 site, 1 recruiting
- Recruiting
Swedish Cancer Institute
Seattle, Washington, 98104
Fengting Yan
Fengting Yan
About this study
Official title: A Phase 1/2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of ZB716 as Monotherapy and in Combination With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
For patients with ER-positive, HER2-negative breast cancer, blockage of the ER pathway has been proven to be an effective anticancer approach. These patients showed good response to endocrine therapy.
Fulvestrant, the approved SERD as monotherapy or in combination with CDK4/6 inhibitors, showed superior clinical benefit compared to other endocrine therapies. Fulvestrant exhibits differential mechanism of action from other endocrine therapy, such as tamoxifen, aromatase inhibitors, which indicates that direct blockage of ER might derive better clinical activity.
Read more
However, due to its route of administration by intramuscular injection, the clinical application is limited, especially with long term use. In addition, a higher dose of fulvestrant at 500 mg showed better overall survival than the lower dose at 250 mg, suggesting that more profound ER pathway modulation could derive better clinical benefit. Therefore, a SERD with improved oral bioavailability and good safety profile which enables its overdose is anticipated to achieve a more satisfactory clinical outcome with better compliance of clinical use.
Preclinical data indicates that ZB716 is a novel orally bioavailable, selective ERα degrader with full ER antagonism that demonstrates superior properties than Fulvestrant. Thus, it has a potential to be effective therapy for patients with ER-positive breast cancer.
This is the first time ZB716 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when ZB716 is administered orally as monotherapy and in combination with palbociclib to subjects with ER-positive, HER2 negative advanced breast cancer. This information, together with the PK data, will help establish the doses and dosing regimen suitable for future studies in patients. The PD effect of ZB716 on the select biomarkers for cytochrome P450 (CYP)3A4 induction (4β hydroxycholesterol) and expression of ER, PgR, and Ki67 will also be investigated. The effect of ZB716 on antitumor activity as measured by objective response rate (ORR), clinical benefit rate (CBR), duration of response (DOR), and PFS rate will also be investigated. The study will also investigate the effects of food on the PK of ZB716 monotherapy.
- Conditions
- Estrogen Receptor-Positive, HER2-Negative, Locally Advanced Breast Cancer, Metastatic Breast Cancer
- Being tested
- ZB716, Palbociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZB716Drug
Also called Borestrant
Pharmaceutical form: capsule Route of administration: oral
PalbociclibDrug
Also called Ibrance®
Pharmaceutical form: capsule Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose Escalation of ZB716 monotherapy (with Food Effect Cohort) | Experimental | 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. Receives: Drug: ZB716 |
| Part B: Dose Expansion of ZB716 monotherapy | Experimental | 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. Receives: Drug: ZB716 |
| Part C: Dose Escalation of ZB716 in combination with palbociclib | Experimental | 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. Receives: Drug: ZB716; Drug: Palbociclib |
| Part D: Dose Expansion of ZB716 in combination with palbociclib | Experimental | 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. Receives: Drug: ZB716; Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: To determine the RD(Recommended Dose) of ZB716
Incidence of study treatment-related DLTs at Cycle 1
Measured: At the end of Cycle 1 (each cycle is 28 days)
Part B: To assess antitumor activities at the ZB716 RD in monotherapy
Proportion of patients with CR(Complete Response), PR(Partial Response) or SD(Stable Disease) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by independent central reviewer relative to the total number of treated patients
Measured: Baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered patient
Part C: To determine the RD of ZB716 in combination with palbociclib
Incidence of study treatment-related DLTs at Cycle 1
Measured: At the end of Cycle 1 (each cycle is 28 days)
Part D: To assess antitumor activities in the combination therapy of ZB716 and Palbociclib
Proportion of patients with CR(Complete Response), PR(Partial Response) or SD(Stable Disease) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by independent central reviewer relative to the total number of treated patients
Measured: Baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered patient
Secondary outcomes (16)
Adverse Events (Part A, B, C and D)
Number of patients with adverse events according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 5.0 grade scaling. Incidence of adverse events, including laboratory test results and electrocardiogram (ECG) findings that were adverse events
Measured: Up to 30 days after last dose of ZB716 or ZB716 with Palbociclib
ORR(Object Response Rate) (Part A, B, C and D)
Proportion of patients with CR(Complete Response) or PR(Partial Response) according to RECIST 1.1 assessed by investigator/local radiologist
Measured: Baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered patient
CBR(Clinical Benefit Rate) (Part A and C)
Proportion of patients with CR(Complete Response) or PR(Partial Response) or SD(Stable Disease) ≥16 weeks according to RECIST v.1.1 relative to the total number of treated patients by investigators/local radiologists
Measured: Baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered patient
Duration of response (Part A, B, C and D)
Time from initial response to the first documented tumor progression
Measured: Baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered patient
Cmax of ZB716 after single dose (Part A, B, C and D)
Cmax is maximum concentration observed.
Measured: Cycle 0, Day -7 (Part A), Cycle 1, Day 1 (Part B, C and D) (each cycle is 28 days)
Tmax of ZB716 after single dose (Part A, B, C and D)
Tmax is time to reach Cmax.
Measured: Cycle 0, Day -7 (Part A), Cycle 1, Day 1 (Part B, C and D) (each cycle is 28 days)
AUC0-24 of ZB716 after single dose (Part A, B, C and D)
AUC0-24 is area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours)
Measured: Cycle 0, Day -7 (Part A), Cycle 1, Day 1 (Part B, C and D) (each cycle is 28 days)
Cmax of ZB716 after repeated dose (Part A, B, C and D)
Cmax is maximum concentration observed.
Measured: Cycle 2, Day 1 (Part A), Cycle 1, Day 15 (Part B, C and D) (each cycle is 28 days)
Tmax of ZB716 after repeated dose (Part A, B, C and D)
Tmax is time to reach Cmax.
Measured: Cycle 2, Day 1 (Part A), Cycle 1, Day 15 (Part B, C and D) (each cycle is 28 days)
AUC0-24 of ZB716 after repeated dose (Part A, B, C and D)
AUC0-24 is area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours)
Measured: Cycle 2, Day 1 (Part A), Cycle 1, Day 15 (Part B, C and D) (each cycle is 28 days)
Cmax of Palbociclib after single dose (Part C and D)
Cmax is maximum concentration observed.
Measured: Cycle 1, Day 1 (Part C and D) (each cycle is 28 days)
Tmax of Palbociclib after single dose (Part C and D)
Tmax is time to reach Cmax.
Measured: Cycle 1, Day 1 (Part C and D) (each cycle is 28 days)
AUC0-24 of Palbociclib after single dose (Part C and D)
AUC0-24 is area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours)
Measured: Cycle 1, Day 1 (Part C and D) (each cycle is 28 days)
Cmax of Palbociclib after repeated dose (Part C and D)
Cmax is maximum concentration observed.
Measured: Cycle 1, Day 15 (Part C and D) (each cycle is 28 days)
Tmax of Palbociclib after repeated dose (Part C and D)
Tmax is time to reach Cmax.
Measured: Cycle 1, Day 15 (Part C and D) (each cycle is 28 days)
AUC0-24 of Palbociclib after repeated dose (Part C and D)
AUC0-24 is area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours)
Measured: Cycle 1, Day 15 (Part C and D) (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start26 Jul 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estrogen Receptor-PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EnhancedBio USA Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Zenopharm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669587
- Sponsor's protocol ID
- ENZENO-C-101
- Acronym
- ENZENO
- Status last verified
- Mar 2022
- First submitted
- 15 Nov 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of ZB716 as Monotherapy and in Combination With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04669587
- Acronym / sponsor ID
- ENZENO / ENZENO-C-101
- Conditions
- Estrogen Receptor-Positive, HER2-Negative, Locally Advanced Breast Cancer, Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- EnhancedBio USA Inc.University, hospital or other
- Collaborators
- Zenopharm
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For patients with ER-positive, HER2-negative breast cancer, blockage of the ER pathway has been proven to be an effective anticancer approach. These patients showed good response to endocrine therapy.
Fulvestrant, the approved SERD as monotherapy or in combination with CDK4/6 inhibitors, showed superior clinical benefit compared to other endocrine therapies. Fulvestrant exhibits differential mechanism of action from other endocrine therapy, such as tamoxifen, aromatase inhibitors, which indicates that direct blockage of ER might derive better clinical activity.
However, due to its route of administration by intramuscular injection, the clinical application is limited, especially with long term use. In addition, a higher dose of fulvestrant at 500 mg showed better overall survival than the lower dose at 250 mg, suggesting that more profound ER pathway modulation could derive better clinical benefit. Therefore, a SERD with improved oral bioavailability and good safety profile which enables its overdose is anticipated to achieve a more satisfactory clinical outcome with better compliance of clinical use.
Preclinical data indicates that ZB716 is a novel orally bioavailable, selective ERα degrader with full ER antagonism that demonstrates superior properties than Fulvestrant. Thus, it has a potential to be effective therapy for patients with ER-positive breast cancer.
This is the first time ZB716 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when ZB716 is administered orally as monotherapy and in combination with palbociclib to subjects with ER-positive, HER2 negative advanced breast cancer. This information, together with the PK data, will help establish the doses and dosing regimen suitable for future studies in patients. The PD effect of ZB716 on the select biomarkers for cytochrome P450 (CYP)3A4 induction (4β hydroxycholesterol) and expression of ER, PgR, and Ki67 will also be investigated. The effect of ZB716 on antitumor activity as measured by objective response rate (ORR), clinical benefit rate (CBR), duration of response (DOR), and PFS rate will also be investigated. The study will also investigate the effects of food on the PK of ZB716 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose Escalation of ZB716 monotherapy (with Food Effect Cohort) | Experimental | Drug: ZB716Cohorts 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. |
| Part B: Dose Expansion of ZB716 monotherapy | Experimental | Drug: ZB716Potential 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. |
| Part C: Dose Escalation of ZB716 in combination with palbociclib | Experimental | Drug: ZB716, Drug: PalbociclibCohorts 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. |
| Part D: Dose Expansion of ZB716 in combination with palbociclib | Experimental | Drug: ZB716, Drug: PalbociclibPotential 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZB716Also: BorestrantPharmaceutical form: capsule Route of administration: oral | Drug | Part A: Dose Escalation of ZB716 monotherapy (with Food Effect Cohort), Part B: Dose Expansion of ZB716 monotherapy, Part C: Dose Escalation of ZB716 in combination with palbociclib, Part D: Dose Expansion of ZB716 in combination with palbociclib |
| PalbociclibAlso: Ibrance®Pharmaceutical form: capsule Route of administration: oral | Drug | Part C: Dose Escalation of ZB716 in combination with palbociclib, Part D: Dose Expansion of ZB716 in combination with palbociclib |
Primary outcome
Part A: To determine the RD(Recommended Dose) of ZB716
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Incidence of study treatment-related DLTs at Cycle 1
Part B: To assess antitumor activities at the ZB716 RD in monotherapy
Time frame: Baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered patient
Proportion of patients with CR(Complete Response), PR(Partial Response) or SD(Stable Disease) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by independent central reviewer relative to the total number of treated patients
Part C: To determine the RD of ZB716 in combination with palbociclib
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Incidence of study treatment-related DLTs at Cycle 1
Part D: To assess antitumor activities in the combination therapy of ZB716 and Palbociclib
Time frame: Baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered patient
Proportion of patients with CR(Complete Response), PR(Partial Response) or SD(Stable Disease) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by independent central reviewer relative to the total number of treated patients
16 secondary outcomes
Adverse Events (Part A, B, C and D)
Time frame: Up to 30 days after last dose of ZB716 or ZB716 with Palbociclib
ORR(Object Response Rate) (Part A, B, C and D)
Time frame: Baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered patient
CBR(Clinical Benefit Rate) (Part A and C)
Time frame: Baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered patient
Duration of response (Part A, B, C and D)
Time frame: Baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered patient
Cmax of ZB716 after single dose (Part A, B, C and D)
Time frame: Cycle 0, Day -7 (Part A), Cycle 1, Day 1 (Part B, C and D) (each cycle is 28 days)
Tmax of ZB716 after single dose (Part A, B, C and D)
Time frame: Cycle 0, Day -7 (Part A), Cycle 1, Day 1 (Part B, C and D) (each cycle is 28 days)
AUC0-24 of ZB716 after single dose (Part A, B, C and D)
Time frame: Cycle 0, Day -7 (Part A), Cycle 1, Day 1 (Part B, C and D) (each cycle is 28 days)
Cmax of ZB716 after repeated dose (Part A, B, C and D)
Time frame: Cycle 2, Day 1 (Part A), Cycle 1, Day 15 (Part B, C and D) (each cycle is 28 days)
Tmax of ZB716 after repeated dose (Part A, B, C and D)
Time frame: Cycle 2, Day 1 (Part A), Cycle 1, Day 15 (Part B, C and D) (each cycle is 28 days)
AUC0-24 of ZB716 after repeated dose (Part A, B, C and D)
Time frame: Cycle 2, Day 1 (Part A), Cycle 1, Day 15 (Part B, C and D) (each cycle is 28 days)
Cmax of Palbociclib after single dose (Part C and D)
Time frame: Cycle 1, Day 1 (Part C and D) (each cycle is 28 days)
Tmax of Palbociclib after single dose (Part C and D)
Time frame: Cycle 1, Day 1 (Part C and D) (each cycle is 28 days)
AUC0-24 of Palbociclib after single dose (Part C and D)
Time frame: Cycle 1, Day 1 (Part C and D) (each cycle is 28 days)
Cmax of Palbociclib after repeated dose (Part C and D)
Time frame: Cycle 1, Day 15 (Part C and D) (each cycle is 28 days)
Tmax of Palbociclib after repeated dose (Part C and D)
Time frame: Cycle 1, Day 15 (Part C and D) (each cycle is 28 days)
AUC0-24 of Palbociclib after repeated dose (Part C and D)
Time frame: Cycle 1, Day 15 (Part C and D) (each cycle is 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
Not yet recruiting
Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of Estrogen Receptor 1 (ESR1) Mutations in (Human Epidermal Growth Factor Receptor) HR+/HER2- Metastatic Breast Cancer (MBC)
Breast Cancer, Metastatic Breast Cancer
Recruiting
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
Breast Neoplasms, Carcinoma, Ductal, Breast
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZB716 and Palbociclib in people with Estrogen Receptor-Positive and HER2-Negative, run by EnhancedBio USA Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EnhancedBio Inc. (1-504-236-5452, sophia@enhancedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: To determine the RD(Recommended Dose) of ZB716 (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.