Breast NeoplasmsPhase 1NCT04852419
A PHASE 1B STUDY OF ZN-C5 IN CHINESE SUBJECTS
A Phase 1 study testing ZN-c5 in people with Breast Neoplasms, run by Zentera Therapeutics HK Limited at 1 site in China.
Trial summary
The aim of this phase 1b study in Chinese patients with ER+/Her2- advanced breast cancer is to evaluate the safety and tolerability of ZN-c5 at dose of 50 mg and 150 mg QD well tolerance established in the previous oversea study in non-Chinese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- ZN-c5
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2021to 23 Jun 2022
- Phase
- Phase 1
- 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
Who may be able to join
- Male or female
- Age ≥ 18 years
- Menopausal Status [Female subjects]
- Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast, not amenable to any potential curative intervention
- Estrogen Receptor (ER) positive disease
- Human Epidermal Growth Factor Receptor 2 (HER2) negative disease
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- Refractory to or intolerant of established therapy(ies) known to provide clinical benefit for their malignancy
- Prior Hormonal Therapy:
- Documented prior response to endocrine therapy for advanced or metastatic disease (SD, PR, or CR) lasting > 6 months24 weeks or disease recurrence after at least 24 months of adjuvant endocrine treatment.
- Prior Chemotherapy: Up to 2 prior lines of chemotherapy for the treatment of advanced breast cancer
- Prior treatment with a CDK4/6 inhibitor is allowed
- Evaluable or measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
- All acute toxic effects of any prior anti-tumor therapy resolved to Grade ≤ 1 or baseline (with the exception of alopecia [any grade permitted])
- Adequate organ function
- [Premenopausal and perimenopausal female subjects]: Negative serum pregnancy test
- Male and female subjects of childbearing potential or partners of subjects who engage in intercourse must agree to use protocol specified method(s) of contraception.
Who cannot join
- Any of the following within the specified window prior to the first dose of study drug
- Prior hematopoietic stem cell or bone marrow transplantation
- Prior radiotherapy to > 25% of bone marrow
- Brain metastases that require immediate treatment or are clinically or radiologically unstable (i.e., have been stable for < 1 month). If receiving steroids, subjects must be receiving a stable to decreasing corticosteroid dose during at least 1 week before enrollment.
- Leptomeningeal disease that requires or is anticipated to require immediate treatment.
- Presence of life-threatening metastatic visceral disease or symptomatic pulmonary lymphangitic spread
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- Other known active cancer(s) likely to require treatment in the next year that would impact the assessment of any study endpoints
- [Female subjects]: Pregnant or breast-feeding
- Unexplained symptomatic endometrial disorders (including, but not limited to endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
- Impairment of gastrointestinal (GI) absorption for oral medications
- Nausea, vomiting, or diarrhea > Grade 1
- Myocardial infarction, symptomatic congestive heart failure (NYHA > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months
- QTc interval > 480 msec (based on the mean value of the triplicate ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or history of Torsade de Pointes
- Concurrent use of food or drugs known to be moderate or strong CYP3A or CYP2C9 inducers and moderate or strong CYP3A4 or CYP2C9 inhibitors.
- Positive serum virological tests (HBsAg, HCV-AB, HIV-AB, TP-AB) at screening stage will be excluded.
- Any clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE 1B STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF ZN-C5 IN CHINESE SUBJECTS WITH ADVANCED BREAST CANCER
The aim of this phase 1b study in Chinese patients with ER+/Her2- advanced breast cancer is to evaluate the safety and tolerability of ZN-c5 at dose of 50 mg and 150 mg QD well tolerance established in the previous oversea study in non-Chinese patients.
Read the detailed description
Hormone receptor-positive, HER2-negative breast cancer is the most common subset of breast cancer. The estrogen receptor (ER) in these patients is a key driver of disease progression, and the primary reason for relapse in these patients is that endocrine therapies are only partially effective, typically causing cell cycle arrest rather than cell death. As a result, secondary resistance to endocrine therapy is a major clinical challenge. ZN-c5 is a novel and potent ZN-c5 is a novel and potent selective estrogen receptor degrader with oral bioavailability and strong activity in estrogen-dependent and tamoxifen-resistant tumor models.
- Conditions
- Breast Neoplasms
- Being tested
- ZN-c5
- Keywords
- ER Positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZN-c5Drug
ZN-c5
| Study group | Role | What they receive |
|---|---|---|
| ZN-c5 50mg QD dose cohort | Experimental | Phase 1b trial of monotherapy cohort with ZN-c5 as single agent will be evaluated with ZN-c5 50 mg administered orally, once daily. Safety lead in phase will be applied. Receives: Drug: ZN-c5 |
| Zn-c5 150mg QD dose cohort | Experimental | Once safety and tolerability are established in ZN-c5 150 mg Dose QD in Chinese population, then it is possible to initiate the second monotherapy cohort with 150 mg QD or alternative dose well established in oversea population for preliminary efficacy and safety. Receives: Drug: ZN-c5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Dose Limited Toxicities (DLTs) in safety lead in phase
Safety lead in phase at dose of 50 mg QD: Determine a tolerated dose for ZN-c5 in monotherapy
Measured: At the end of Cycle 1 (each cycle is 28 days)
Incidence of treatment-emergent adverse events
Investigate the safety and tolerability of dose of 50 mg QD of ZN-c5
Measured: until 30 days after the last dose of study drug
Incidence of treatment-emergent adverse events
Investigate the safety and tolerability of dose of 150 mg QD of ZN-c5
Measured: until 30 days after the last dose of study drug
Secondary outcomes (4)
CBR (CR [+ PR] + SD ≥ 24 weeks).
Investigate the preliminary antitumor activity (clinical benefit rate [CBR]) for ZN-c5 as a monotherapy using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) as assessed by investigators.
Measured: 2 year
bjective Response Rate (ORR)
Assess preliminary antitumor activity of ZN-c5 alone by Objective Response Rate （ORR) using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) as assessed by investigators.
Measured: 2 year
Duration of Response (DOR)
Assess preliminary antitumor activity of ZN-c5 alone by Duration of Response (DOR) using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) as assessed by investigators.
Measured: 2 year
Progression-Free Survival (PFS)
Assess preliminary antitumor activity of ZN-c5 alone by Progression-Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) as assessed by investigators.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start31 May 2021
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zentera Therapeutics HK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852419
- Sponsor's protocol ID
- c5ZTCN100
- Status last verified
- Aug 2022
- First submitted
- 11 Apr 2021
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1B STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF ZN-C5 IN CHINESE SUBJECTS WITH ADVANCED BREAST CANCER
- ClinicalTrials.gov ID
- NCT04852419
- Acronym / sponsor ID
- c5ZTCN100
- Conditions
- Breast Neoplasms
- Keywords
- ER Positive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Zentera Therapeutics HK LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 21 Apr 2021 (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.
The aim of this phase 1b study in Chinese patients with ER+/Her2- advanced breast cancer is to evaluate the safety and tolerability of ZN-c5 at dose of 50 mg and 150 mg QD well tolerance established in the previous oversea study in non-Chinese patients.
Detailed description
Hormone receptor-positive, HER2-negative breast cancer is the most common subset of breast cancer. The estrogen receptor (ER) in these patients is a key driver of disease progression, and the primary reason for relapse in these patients is that endocrine therapies are only partially effective, typically causing cell cycle arrest rather than cell death. As a result, secondary resistance to endocrine therapy is a major clinical challenge. ZN-c5 is a novel and potent ZN-c5 is a novel and potent selective estrogen receptor degrader with oral bioavailability and strong activity in estrogen-dependent and tamoxifen-resistant tumor models.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZN-c5 50mg QD dose cohort | Experimental | Drug: ZN-c5Phase 1b trial of monotherapy cohort with ZN-c5 as single agent will be evaluated with ZN-c5 50 mg administered orally, once daily. Safety lead in phase will be applied. |
| Zn-c5 150mg QD dose cohort | Experimental | Drug: ZN-c5Once safety and tolerability are established in ZN-c5 150 mg Dose QD in Chinese population, then it is possible to initiate the second monotherapy cohort with 150 mg QD or alternative dose well established in oversea population for preliminary efficacy and safety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female
- Age ≥ 18 years
- Menopausal Status [Female subjects]
- Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast, not amenable to any potential curative intervention
- Estrogen Receptor (ER) positive disease
Key exclusion criteria (16 listed)
- Any of the following within the specified window prior to the first dose of study drug
- Prior hematopoietic stem cell or bone marrow transplantation
- Prior radiotherapy to > 25% of bone marrow
- Brain metastases that require immediate treatment or are clinically or radiologically unstable (i.e., have been stable for < 1 month). If receiving steroids, subjects must be receiving a stable to decreasing corticosteroid dose during at least 1 week before enrollment.
- Leptomeningeal disease that requires or is anticipated to require immediate treatment.
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 |
|---|---|---|
| ZN-c5ZN-c5 | Drug | ZN-c5 50mg QD dose cohort, Zn-c5 150mg QD dose cohort |
Primary outcome
Observed Dose Limited Toxicities (DLTs) in safety lead in phase
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Safety lead in phase at dose of 50 mg QD: Determine a tolerated dose for ZN-c5 in monotherapy
Incidence of treatment-emergent adverse events
Time frame: until 30 days after the last dose of study drug
Investigate the safety and tolerability of dose of 50 mg QD of ZN-c5
Incidence of treatment-emergent adverse events
Time frame: until 30 days after the last dose of study drug
Investigate the safety and tolerability of dose of 150 mg QD of ZN-c5
4 secondary outcomes
CBR (CR [+ PR] + SD ≥ 24 weeks).
Time frame: 2 year
bjective Response Rate (ORR)
Time frame: 2 year
Duration of Response (DOR)
Time frame: 2 year
Progression-Free Survival (PFS)
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZN-c5 in people with Breast Neoplasms, run by Zentera Therapeutics HK Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. 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: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed Dose Limited Toxicities (DLTs) in safety lead in phase (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 3 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 11 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.