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

NCT04852419 | Completed Phase 1 FDA Drug

• 1 other identifier: c5ZTCN100
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 in the previous oversea study in non-Chinese patients.

Conditions

Breast Neoplasms

Keywords

ER Positive

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  until 30 days after the last dose of study drug

Secondary Outcomes (4)

• CBR (CR [+ PR] + SD ≥ 24 weeks).

  2 year

• bjective Response Rate (ORR)

  2 year

• Duration of Response (DOR)

  2 year

• Progression-Free Survival (PFS)

  2 year

Study Arms (2)

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.

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.

Drug: ZN-c5

Interventions

ZN-c5 DRUG

ZN-c5

ZN-c5 50mg QD dose cohort; Zn-c5 150mg QD dose cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zentera Therapeutics HK Limited: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 21, 2021
• Study Start: May 31, 2021
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

CN (1)