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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Pain in extremity

Hypertrichosis

Hyperglycaemia

Psoriasis

Dyspepsia

Frequent bowel movements

Oedema peripheral

Hepatic pain

COVID-19

Urinary tract infection

Vaginal discharge

Haemoptysis

Hyperphosphataemia

Diarrhoea

Hypertension

Decreased appetite

Skin mass

Uterine haemorrhage

Hypotension

Diplopia

Blood creatinine increased

Back pain

Metastases to skin

Epistaxis

ALT increased

Breast pain

Pelvic pain

Vomiting

Micturition urgency

Malignant pleural effusion

100%

80%

60%

40%

20%

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