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ZN-c5 for 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

100%

Neutrophil count decreased

67%

White blood cell count decreased

67%

Nausea

67%

Lymphocyte count decreased

67%

Anaemia

67%

Fatigue

67%

Rash maculo-papular

33%

Paraesthesia

33%

Constipation

33%

Dyspepsia

33%

Stomatitis

33%

Oedema peripheral

33%

Contusion

33%

Fall

33%

Platelet count decreased

33%

Proteinuria

33%

Hot flush

33%

Abdominal distension

33%

Insomnia

33%

Plantar fasciitis

33%

AST increased

33%

Blood cholesterol increased

33%

Arthralgia

33%

Arthritis

33%

Myalgia

33%

Embolism

33%

Abdominal pain

33%

Diarrhoea

33%

Headache

33%

Dyspnoea

33%

Skin lesion

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1 (Combination Therapy): ZN-c5 150mg QD + Palbociclib

Phase 1 (Monotherapy): ZN-c5 75 mg BID

Phase 1 (Monotherapy): ZN-c5 150 mg QD

Phase 1 (Monotherapy): ZN-c5 75 mg QD

Phase 1 (Monotherapy): ZN-c5 150 mg BID

Phase 1 (Monotherapy): ZN-c5 300 mg QD

Phase 1 (Combination Therapy): ZN-c5 50mg BID + Palbociclib

Phase 1 (Combination Therapy): ZN-c5 100mg QD + Palbociclib

Phase 2 (Monotherapy): ZN-c5 50 mg QD

Phase 1 (Combination Therapy): ZN-c5 25mg BID + Palbociclib

Phase 1 (Monotherapy): ZN-c5 50 mg QD

Phase 1 (Combination Therapy): ZN-c5 25mg QD + Palbociclib

Phase 1 (Combination Therapy): ZN-c5 50mg QD + Palbociclib

Phase 1 (Monotherapy): ZN-c5 100 mg QD

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

~3880