Breast CancerPhase 1NCT04514159
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
A Phase 1 study testing ZN-c5 and Abemaciclib in people with Breast Cancer, run by Zeno Alpha Inc. at 5 sites in 2 countries.
Trial summary
This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ZN-c5 and Abemaciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 12 Nov 2020to 24 Oct 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
- Age ≥ 18 years of age
- Women can be peri- or postmenopausal, as defined by at least one of the following:
- Age ≥ 60 years;
- Age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;
- Documented bilateral oophorectomy;
- Must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication
Show all 10Show fewer
- Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast
- Estrogen receptor positive disease
- Human Epidermal Growth Factor Receptor 2 negative disease
- Measurable disease per Response Evaluation Criteria in Solid Tumors v1.1
Who cannot join
- Prior therapy within the following windows:
- Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy < 14 days;
- Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter)
- Any prior systemic chemotherapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity
- Prior treatment with CDK4/6 inhibitors
- Unexplained symptomatic endometrial disorders (including, but not limited to, endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States2 sites
Site 1
Charleston, South Carolina, 29414
Site 2
Gilbert, Arizona, 85234
About this study
Official title: A Phase 1b Study of ZN-c5 in Combination With Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer
This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) breast cancer.
- Conditions
- Breast Cancer
- Being tested
- ZN-c5, Abemaciclib
- Keywords
- Dose escalation, Phase 1 combination, Selective estrogen receptor degrader, Hormone sensitive, Estrogen receptor, Hormone receptor
- 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 is the study drug.
AbemaciclibDrug
Also called VERZENIO®
Abemaciclib (VERZENIO®) is an approved drug.
| Study group | Role | What they receive |
|---|---|---|
| ZN-c5 + abemaciclib combination therapy | Experimental | Participants will take abemaciclib (150mg) orally twice a day and ZN-c5 (dose escalation) orally once or twice a day to determine the safety, tolerability, and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). Receives: Drug: ZN-c5; Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib
Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Measured: Through study completion, anticipated to be 21 months
Secondary outcomes (1)
Determine tumor responses to combination treatment
Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.
Measured: Through study completion, anticipated to be 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start12 Nov 2020
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same treatment but ZN-c5 will be given at different doses in this dose escalation study.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeno Alpha Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carrie Brownstein, MD, Study chair, Zeno Alpha Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514159
- Sponsor's protocol ID
- ZN-c5-003
- Status last verified
- Jan 2023
- First submitted
- 11 Aug 2020
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of ZN-c5 in Combination With Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04514159
- Acronym / sponsor ID
- ZN-c5-003
- Conditions
- Breast Cancer
- Keywords
- Dose escalation, Phase 1 combination, Selective estrogen receptor degrader, Hormone sensitive, Estrogen receptor, Hormone receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Zeno Alpha Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 14 Aug 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.
This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same treatment but ZN-c5 will be given at different doses in this dose escalation study.
| Arm | Type | Receives |
|---|---|---|
| ZN-c5 + abemaciclib combination therapy | Experimental | Drug: ZN-c5, Drug: AbemaciclibParticipants will take abemaciclib (150mg) orally twice a day and ZN-c5 (dose escalation) orally once or twice a day to determine the safety, tolerability, and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years of age
- Women can be peri- or postmenopausal, as defined by at least one of the following:
- Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast
- Estrogen receptor positive disease
- Human Epidermal Growth Factor Receptor 2 negative disease
Key exclusion criteria (6 listed)
- Prior therapy within the following windows:
- Prior treatment with CDK4/6 inhibitors
- Unexplained symptomatic endometrial disorders (including, but not limited to, endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
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 is the study drug. | Drug | ZN-c5 + abemaciclib combination therapy |
| AbemaciclibAlso: VERZENIO®Abemaciclib (VERZENIO®) is an approved drug. | Drug | ZN-c5 + abemaciclib combination therapy |
Primary outcome
Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib
Time frame: Through study completion, anticipated to be 21 months
Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
1 secondary outcome
Determine tumor responses to combination treatment
Time frame: Through study completion, anticipated to be 21 months
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 1 Feb 2023.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Carrie Brownstein, MD study chair
Zeno Alpha Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZN-c5 and Abemaciclib in people with Breast Cancer, run by Zeno Alpha Inc. at 5 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?
The sponsor lists 10 inclusion and 6 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 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland, 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 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?
Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib (time frame: Through study completion, anticipated to be 21 months). 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 1 Feb 2023.