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WEE1 Inhibitor

Azenosertib + Carboplatin + Pembrolizumab for Breast Cancer

Boston, MA

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

No Placebo-Only Group

Summary

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

See full description

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD)

Number of Participants Experiencing Dose Limiting Toxicity (DLT)

Objective Response Rate (ORR)

Secondary study objectives

Clinical Beneficial Rate (CBR)

Duration of Response (DOR)

Grade 3-5 Treatment-Related Toxicity Rate

+2 more

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: 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

~6450

Pembrolizumab

2017

Completed Phase 3

~2630