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Antimicrotubule Agent

ZEN-3694 + Pembrolizumab + Chemotherapy for Breast Cancer

Phase 1
Recruiting
Led By Ana C Garrido-Castro
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
Serum or plasma creatinine =< 1.5 x institutional ULN OR GFR >= 60 mL/min
Patients with a history of HCV infection must have been treated and cured
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trialtests a combo of drugs to treat advanced triple-negative breast cancer: chemo, immunotherapy and a drug to stop tumor cell growth.

Who is the study for?
This trial is for adults with advanced triple-negative breast cancer that's spread and can't be removed by surgery. Participants must have acceptable organ function, no severe prior reactions to similar drugs, and not be on certain medications that affect the study drugs. They should not have had recent chemotherapy or immunotherapy, and women of childbearing age must use contraception.Check my eligibility
What is being tested?
The trial tests ZEN003694 (a BET protein inhibitor) combined with pembrolizumab (an immunotherapy drug) and nab-paclitaxel (a form of chemotherapy). It aims to see if this combination is safer and more effective than standard treatments in shrinking or stabilizing cancer.See study design
What are the potential side effects?
Potential side effects include typical chemotherapy-related issues like fatigue, hair loss, nerve damage, blood disorders; immune-related reactions from pembrolizumab; plus any unknown risks from the new drug ZEN003694.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is within the normal range.
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I had hepatitis C but have been successfully treated and cured.
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My heart condition allows me to perform daily activities with slight limitations.
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My cancer can be measured or evaluated using specific criteria.
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My tests clearly show that my cancer has spread.
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I am 18 years old or older.
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My blood clotting time is normal or slightly above, unless I'm on blood thinners.
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I can swallow and keep down pills.
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My nerve damage does not significantly affect my daily activities.
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I can take care of myself but might not be able to do heavy physical work.
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My breast cancer is triple-negative, not responding to hormones or HER2 treatments.
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My chronic HBV is undetectable with treatment.
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My cancer cannot be removed by surgery and has spread.
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My blood clotting time is normal or near normal, unless I'm on blood thinners.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Incidence of adverse events
Maximum tolerated dose (MTD) of ZEN003694 (ZEN-3694) used in combination with pembrolizumab and nab-paclitaxel
Recommended phase 2 dose (RP2D) of ZEN003694 (ZEN-3694) used in combination with pembrolizumab and nab-paclitaxel
Secondary outcome measures
Changes in potential biomarkers
Duration of response (DoR)
Overall response rate (ORR)
+5 more
Other outcome measures
Potential biomarker indicators of response and resistance to the triplet combination

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Expansion (ZEN003694, nab-paclitaxel, pembrolizumab)Experimental Treatment7 Interventions
Patients receive ZEN003694 PO QD on days 1-7 prior to combination therapy. Patients then receive ZEN003694 PO QD on days 1-21, nab-paclitaxel IV over 30 minutes on days 1, 8, and 15, and pembrolizumab IV over 30 minutes every 21 days of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity with a maximum of 35 doses of pembrolizumab administered. Patients also undergo biopsies on study, and CT or MRI scans and collection of blood samples throughout the trial.
Group II: Dose Escalation (ZEN003694, nab-paclitaxel, pembrolizumab)Experimental Treatment7 Interventions
Patients receive ZEN003694 PO QD on days 1-21, nab-paclitaxel IV over 30 minutes on day 1, 8, and 15, and pembrolizumab IV over 30 minutes every 21 days of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity with a maximum of 35 doses of pembrolizumab administered. Patients also undergo CT or MRI scan and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2790
Biospecimen Collection
2004
Completed Phase 2
~1920
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Nab-paclitaxel
2014
Completed Phase 3
~2030
Pembrolizumab
2017
Completed Phase 2
~2010
Biopsy
2014
Completed Phase 4
~840

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,290 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 Patients Enrolled for Breast Cancer
Ana C Garrido-CastroPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO

Media Library

Nab-paclitaxel (Antimicrotubule Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05422794 — Phase 1
Breast Cancer Research Study Groups: Dose Escalation (ZEN003694, nab-paclitaxel, pembrolizumab), Dose Expansion (ZEN003694, nab-paclitaxel, pembrolizumab)
Breast Cancer Clinical Trial 2023: Nab-paclitaxel Highlights & Side Effects. Trial Name: NCT05422794 — Phase 1
Nab-paclitaxel (Antimicrotubule Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05422794 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cohort size of this trial?

"Affirmative. Based on information hosted by clinicaltrials.gov, this experiment is still enrolling participants even though it was initially posted on September 30th 2022 and most recently edited 14 days ago. The trial aims to find 45 individuals from a single location for the study."

Answered by AI

Could you advise if there are any available enrollments for participants?

"As clinicaltrials.gov confirms, this medical research is still enrolling participants and was originally posted on September 30th 2022 before being modified most recently on October 14th 2022."

Answered by AI

What results does the research team anticipate from this endeavor?

"This trial's primary measure of success will be the incidence of adverse events over a 28 day period. Secondary endpoints include Time to Objective Response (TTOR) evaluated by RECIST 1.1 criteria, Overall Survival evaluations also following RECIST guidelines, and an assessment of Overall response rate (ORR)."

Answered by AI

Has the Dose Escalation regimen of ZEN003694, nab-paclitaxel and pembrolizumab been authorized by the FDA?

"Due to its Phase 1 status, our team at Power has determined that the safety of Dose Escalation (ZEN003694, nab-paclitaxel, pembrolizumab) is likely low and rated it a score of 1."

Answered by AI
~38 spots leftby Dec 2025