A PHASE 1B STUDY OF ZN-C5 IN CHINESE SUBJECTS

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zentera Therapeutics HK Limited

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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