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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

No Placebo-Only Group

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last dose of zb716 or zb716 with palbociclib for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3880

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