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A Study of ZN-c5 in Subjects With Breast Cancer

Phase 1 & 2
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 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new oral drug called ZN-c5 in patients with a specific type of advanced breast cancer. The study aims to see if ZN-c5 can safely and effectively stop cancer growth, either by itself or when combined with another drug named palbociclib.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best Overall Response (BOR) for ZN-c5 as a Monotherapy
Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy
Secondary study objectives
Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months
Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months
Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months
+10 more

Side effects data

From 2022 Phase 1 & 2 trial • 181 Patients • NCT03560531
25%
Fatigue
19%
GGT increased
13%
Nausea
13%
Cough
13%
Sinus bradycardia
13%
Arthralgia
6%
Pain in extremity
6%
Hypertrichosis
6%
Hyperglycaemia
6%
Psoriasis
6%
Dyspepsia
6%
Frequent bowel movements
6%
Oedema peripheral
6%
Hepatic pain
6%
COVID-19
6%
Urinary tract infection
6%
Vaginal discharge
6%
Haemoptysis
6%
Hyperphosphataemia
6%
Diarrhoea
6%
Hypertension
6%
Decreased appetite
6%
Skin mass
6%
Uterine haemorrhage
6%
Hypotension
6%
Diplopia
6%
Blood creatinine increased
6%
Back pain
6%
Metastases to skin
6%
Epistaxis
6%
ALT increased
6%
Breast pain
6%
Pelvic pain
6%
Vomiting
6%
Micturition urgency
6%
Malignant pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 (Monotherapy): ZN-c5 50 mg QD
Phase 1 (Monotherapy): ZN-c5 300 mg QD
Phase 1 (Combination Therapy): ZN-c5 100mg QD + Palbociclib
Phase 2 (Monotherapy): ZN-c5 50 mg QD
Phase 1 (Combination Therapy): ZN-c5 25mg QD + Palbociclib
Phase 1 (Monotherapy): ZN-c5 75 mg BID
Phase 1 (Combination Therapy): ZN-c5 150mg QD + Palbociclib
Phase 1 (Monotherapy): ZN-c5 150 mg BID
Phase 1 (Combination Therapy): ZN-c5 50mg BID + Palbociclib
Phase 1 (Monotherapy): ZN-c5 150 mg QD
Phase 1 (Monotherapy): ZN-c5 75 mg QD
Phase 1 (Monotherapy): ZN-c5 100 mg QD
Phase 1 (Combination Therapy): ZN-c5 25mg BID + Palbociclib
Phase 1 (Combination Therapy): ZN-c5 50mg QD + Palbociclib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: ZN-c5 monotherapyExperimental Treatment1 Intervention
Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 as well as expansion cohorts and a Phase 2 cohort.
Group II: ZN-c5 + palbociclib combination therapyExperimental Treatment2 Interventions
Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 in combination with palbociclib as well as a Phase 2 cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZN-c5
2020
Completed Phase 2
~270
Palbociclib
2017
Completed Phase 3
~3790

Find a Location

Who is running the clinical trial?

Zeno Alpha Inc.Lead Sponsor
3 Previous Clinical Trials
69 Total Patients Enrolled
2 Trials studying Breast Cancer
49 Patients Enrolled for Breast Cancer
Carrie Brownstein, MDStudy ChairZeno Alpha Inc.
1 Previous Clinical Trials
14 Total Patients Enrolled
1 Trials studying Breast Cancer
14 Patients Enrolled for Breast Cancer
Mieke Ptaszynski, MDStudy DirectorZeno Alpha Inc.
3 Previous Clinical Trials
174 Total Patients Enrolled
2 Trials studying Breast Cancer
49 Patients Enrolled for Breast Cancer
~26 spots leftby Dec 2025