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WEE1 Inhibitor

Phase 1: Dose Escalation Arm for Breast Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Filipa Lynce, MD

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 up to 5 years

Awards & highlights

Study Summary

This trial is testing a new drug called Azenosertib in combination with carboplatin and pembrolizumab for metastatic triple-negative breast cancer.

Who is the study for?

This trial is for patients with metastatic triple-negative breast cancer. Participants should meet specific health criteria not detailed here.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Azenosertib combined with Carboplatin and Pembrolizumab in treating metastatic triple-negative breast cancer.See study design

What are the potential side effects?

Possible side effects include reactions related to WEE1 inhibitors, platinum compounds, or monoclonal antibodies, but specifics are not provided.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD)

Number of Participants Experiencing Dose Limiting Toxicity (DLT)

Objective Response Rate (ORR)

Secondary outcome measures

Clinical Beneficial Rate (CBR)

Duration of Response (DOR)

Grade 3-5 Treatment-Related Toxicity Rate

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2: AZENOSERTIB + PEMBROLIZUMAB + CARBOPLATINExperimental Treatment3 Interventions

Participants will complete: Baseline visit with CT or MRI scan and tumor biopsy. CT or MRI scan every 9 weeks until 27 weeks then every 12 weeks. Cycle 1 through End of Treatment: Days 1 through 5, 8 through 12, and 15 through 19 of 21 Day Cycle: Predetermined dose of Azenosertib 1x daily. Day 1 of 21 Day Cycle: Predetermined dose of Pembrolizumab 1x daily. Days 1 and 8 of 21 Day Cycle: Predetermined dose of Carboplatin 1x daily. Tumor biopsy during Cycle 2. End of Treatment visit Follow up: every 6 months

Group II: Phase 1: Dose Escalation ArmExperimental Treatment3 Interventions

Participants will be enrolled in a standard 3+3 dose-escalation scheme to establish a Maximum Tolerated dose (MTD) of Azenosertib, starting at Dose Level 0, de-escalating to Dose Level -1, and escalating to Dose Levels 1 and 2. Baseline visit with CT or MRI scan. CT or MRI scan every 9 weeks until 27 weeks then every 12 weeks. Cycle 1 through End of Treatment: Days 1 through 5, 8 through 12, and 15 through 19 of 21 Day Cycle: Predetermined dose of Azenosertib 1 x daily. Day 1 of 21 Day Cycle: Predetermined dose of Pembrolizumab 1x daily. Days 1 and 8 of 21 Day Cycle: Predetermined dose of Carboplatin 1x daily. End of Treatment visit Follow up: every 6 months Dose de-escalation and escalation will follow dose-limiting toxicities specifications (DLTs) per the protocol. The MTD is the highest dose level with ≤1 DLT in a cohort of 6 participants and the study will proceed to Phase 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Zentalis PharmaceuticalsUNKNOWN

1 Previous Clinical Trials

1 Trials studying Breast Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,064 Total Patients Enrolled

58 Trials studying Breast Cancer

7,420 Patients Enrolled for Breast Cancer

Filipa Lynce, MDLead Sponsor

1 Previous Clinical Trials

63 Total Patients Enrolled

1 Trials studying Breast Cancer

63 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.

Are participants currently being recruited for this trial?

"As per the information available on clinicaltrials.gov, recruitment for this particular study has ceased. The trial was first listed on 1st September 2024 and last modified on 2nd April 2024. Despite this trial no longer seeking participants, there are currently 5211 other trials actively recruiting volunteers."

Answered by AI

What are the main goals and purposes of this clinical investigation?

"The key outcome measure for this trial, assessed within a period of approximately up to 3 weeks, is the count of participants experiencing Dose Limiting Toxicity (DLT). Secondary aims encompass evaluating Duration of Response (DOR) defined as the time from initial confirmed objective response to first progressive disease according to RECIST 1.1 guidelines, Clinical Benefit Rate (CBR) representing individuals achieving CR, PR, and SD lasting over 24 weeks based on RECIST 1.1 criteria; Median Progression-Free Survival (PFS) calculated from study entry to documented PD necessitating discontinuation or death with censoring applied for"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT)

Filipa Lynce, MD 2024. "A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06351332.