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Cyclin-Dependent Kinase Inhibitor

ZN-c5 for Breast Cancer

Phase 1
Waitlist Available
Research Sponsored by Zeno Alpha Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, anticipated to be 21 months
Awards & highlights

Study Summary

This trial is testing a new drug, ZN-c5, to see if it is safe to take with abemaciclib, a already existing cancer drug. They want to see if the new drug can help treat ER+/HER2- negative breast cancer.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, anticipated to be 21 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, anticipated to be 21 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib
Secondary outcome measures
Determine tumor responses to combination treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: ZN-c5 + abemaciclib combination therapyExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZN-c5
2020
Completed Phase 2
~270
Abemaciclib
2019
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

Zeno Alpha Inc.Lead Sponsor
3 Previous Clinical Trials
236 Total Patients Enrolled
2 Trials studying Breast Cancer
216 Patients Enrolled for Breast Cancer
Mieke Ptaszynski, MDStudy DirectorZeno Alpha Inc.
2 Previous Clinical Trials
216 Total Patients Enrolled
2 Trials studying Breast Cancer
216 Patients Enrolled for Breast Cancer
Dimitris Voliotis, MDStudy ChairZeno Alpha Inc.
1 Previous Clinical Trials
181 Total Patients Enrolled
1 Trials studying Breast Cancer
181 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
2020. "A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04514159.
~3 spots leftby Apr 2025
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