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Hypomethylation Agent

ASTX727 + Paclitaxel + Pembrolizumab for Breast Cancer

Phase 1

Waitlist Available

Led By Roberto A Leon-Ferre

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable viral load on suppressive therapy

Must not have

History of grade 3-4 immediate hypersensitivity reaction to paclitaxel or other drugs formulated in polyoxyl 35 castor oil

Patients with uncontrolled intercurrent illness or a history of pneumonitis that required steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new combo of drugs to treat advanced triple-negative breast cancer.

Who is the study for?

Adults with metastatic triple-negative breast cancer can join this trial. They should have normal organ function, no severe neuropathy, and be in good physical condition. Prior treatments for cancer are okay if they've recovered from the side effects. People with certain viral infections must have them under control.

What is being tested?

The trial is testing ASTX727 (a combo of decitabine and cedazuridine) added to standard chemotherapy (paclitaxel) and immunotherapy (pembrolizumab). It aims to find a safe dose that might help shrink or stabilize cancer better than the usual treatment alone.

What are the potential side effects?

Possible side effects include reactions related to immune system activation, nerve damage from paclitaxel, blood cell count changes due to decitabine, and gastrointestinal issues affecting medication absorption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have chronic hepatitis B but it's under control with medication.

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I am mostly self-sufficient and can carry out daily activities.

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My kidney function, measured by creatinine clearance, is adequate.

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My heart condition allows me to perform daily activities with slight limitations.

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I have not received any live vaccines in the last 30 days.

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My breast cancer is triple-negative, cannot be removed by surgery, and has spread.

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I had hepatitis C but am now cured or have no detectable virus while on treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had a severe allergic reaction to paclitaxel or similar drugs.

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I have no uncontrolled illnesses or a history of lung inflammation treated with steroids.

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I have an active case of tuberculosis.

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I have another cancer that is getting worse or needs treatment.

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I am allergic to medications similar to ASTX727, pembrolizumab, or paclitaxel.

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I have had a solid organ or bone marrow transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Maximally tolerated dose (MTD) of ASTX727 in combination with paclitaxel and pembrolizumab (MK-3475) (Dose Finding Phase)

Safety profile of ASTX727 in combination with paclitaxel and pembrolizumab (MK-3475) (Dose Finding Phase)

Secondary study objectives

Duration of response (Dose Expansion Phase)

Overall survival (Dose Expansion Phase)

Progression-free survival (Dose Expansion Phase)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ASTX727, paclitaxel, pembrolizumab)Experimental Treatment7 Interventions

Patients receive ASTX727 PO on days 1-4, paclitaxel IV over 1 hour on days 1, 8, and 15, and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples and CT and/or MRI throughout the trial. Patients in the dose-expansion phase also undergo a tumor biopsy during screening and day 1 of the treatment cycle 2 of the study. Patients will be followed every 3 months for 2 years after treatment and then every 6 months for an additional 3 years or until death, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5370

Biopsy

2014

Completed Phase 4

~1090