Status:
COMPLETED
A PHASE 1B STUDY OF ZN-C5 IN CHINESE SUBJECTS
Lead Sponsor:
Zentera Therapeutics HK Limited
Conditions:
Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 i...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04852419
Start Date
May 31 2021
End Date
June 23 2022
Last Update
August 11 2022
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, China