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A Study of ZN-c5 in Subjects With Breast Cancer

NCT03560531 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2024-08-09

Study results available
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Summary

This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).

Conditions

Interventions

DRUG

ZN-c5

ZN-c5 is a study drug

DRUG

Palbociclib

Palbociclib (IBRANCE®) is an approved drug

Sponsors & Collaborators

  • Zeno Alpha Inc.

    lead INDUSTRY

Principal Investigators

  • Zeno Alpha, Inc. · Zeno Alpha Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2022-04-26
Completion
2022-12-22
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Bosnia and Herzegovina
  • Czechia
  • Hungary
  • Lithuania
  • Russia
  • Serbia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03560531 on ClinicalTrials.gov