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WEE1 Inhibitor

Azenosertib + Carboplatin + Pembrolizumab for Breast Cancer

Phase 1 & 2
Recruiting
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

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 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
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670

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
3,919 Previous Clinical Trials
5,068,185 Total Patients Enrolled
58 Trials studying Breast Cancer
7,328 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
~52 spots leftby Mar 2027