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Antimicrotubule Agent

ZEN003694 + Pembrolizumab + Nab-Paclitaxel for Advanced Triple-Negative Breast Cancer

Dana-Farber - Harvard Cancer Center LAO, Boston, MA
Targeting 5 different conditionsComputed Tomography +6 morePhase 1RecruitingLed by Ana C Garrido-CastroResearch Sponsored by National Cancer Institute (NCI)

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.

Eligible Conditions
  • Metastatic Triple-Negative Breast Cancer
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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If you haven't had a biopsy to confirm your cancer has spread, you must have clear signs of metastasis from a physical exam or radiology test.
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You do not need to know your PD-L1 status before joining the study's dose escalation group.
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You have a disease that has spread to other parts of your body and cannot be removed by surgery.
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You can participate if you have been treated for metastatic cancer before.
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If you have had cancer that spread to your brain before but it was treated, you can participate if your cancer is still present outside of your brain and you have recovered from any side effects of previous treatments.
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You may be eligible even if you have cancer that has spread to your brain or the tissues lining your brain and spine (leptomeningeal disease) as long as your doctor believes that you do not need immediate treatment for it and it is unlikely to become a problem during the first cycle of therapy.
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You have had or currently have another type of cancer that won't affect the evaluation of the new treatment.
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If you have had side effects from previous cancer treatment, those side effects must have mostly gone away before you can participate in this trial. However, if you have hair loss (alopecia) from previous treatment, that doesn't matter.
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It is not known if ZEN003694 (ZEN-3694) and MK-3475 can harm an unborn baby.

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

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: 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
~2890
Biospecimen Collection
2004
Completed Phase 1
~1500
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Nab-paclitaxel
2014
Completed Phase 3
~2030
Pembrolizumab
2017
Completed Phase 3
~2030
Biopsy
2014
Completed Phase 4
~1180

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,486 Previous Clinical Trials
41,267,106 Total Patients Enrolled
934 Trials studying Breast Cancer
1,540,727 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
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of Anti-Cancer Drug, ZEN003694 (ZEN-3694) and PD-1 Inhibitor (Pembrolizumab), to Standard Chemotherapy (Nab-Paclitaxel) Treatment in Patients With Advanced Triple-Negative Breast Cancer
2023. "Testing the Addition of Anti-Cancer Drug, ZEN003694 (ZEN-3694) and PD-1 Inhibitor (Pembrolizumab), to Standard Chemotherapy (Nab-Paclitaxel) Treatment in Patients With Advanced Triple-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05422794.
~38 spots leftby Dec 2025
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