Dose Escalation (ZEN003694, nab-paclitaxel, pembrolizumab) for Breast

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast+7 More
Biospecimen Collection - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase Ib trial tests the safety and tolerability of ZEN003694 in combination with immunotherapy PD1 inhibitor (pembrolizumab) and standard chemotherapy (nab-paclitaxel) for the treatment of patients with triple negative-negative breast cancer that has spread to other parts of the body (advanced). Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with pembrolizumab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. ZEN003694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy in combination with ZEN003694 and standard treatment of chemotherapy may help shrink or stabilize cancer for longer than just chemotherapy alone.

Eligible Conditions
  • Breast
  • Anatomic Stage III Breast Cancer AJCC v8
  • Metastatic Triple-Negative Breast Carcinoma
  • Locally Advanced Triple-Negative Breast Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 3 years

Baseline up to post- treatment biopsies
Changes in potential biomarkers
Baseline up to post-treatment biopsies
Potential biomarker indicators of response and resistance to the triplet combination
Year 3
Overall response rate (ORR)
Year 3
Time to objective response (TTOR)
Year 3
Overall survival (OS)
Year 3
Progression-free survival (PFS)
Year 3
Duration of response (DoR)
Up to 28 days
Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of ZEN003694 (ZEN-3694) used in combination with pembrolizumab and nab-paclitaxel
Up to 3 years
Incidence of adverse events
Pharmacokinetics (PK) profile of the combination of ZEN003694 (ZEN-3694), pembrolizumab and nab-paclitaxel
RP2D for future trials

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Dose Escalation (ZEN003694, nab-paclitaxel, pembrolizumab)
1 of 2
Dose Expansion (ZEN003694, nab-paclitaxel, pembrolizumab)
1 of 2

Experimental Treatment

45 Total Participants · 2 Treatment Groups

Primary Treatment: Dose Escalation (ZEN003694, nab-paclitaxel, pembrolizumab) · No Placebo Group · Phase 1

Dose Escalation (ZEN003694, nab-paclitaxel, pembrolizumab)Experimental Group · 7 Interventions: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Pembrolizumab, Nab-paclitaxel, BET Bromodomain Inhibitor ZEN-3694, Biopsy · Intervention Types: Procedure, Procedure, Procedure, Biological, Drug, Drug, Procedure
Dose Expansion (ZEN003694, nab-paclitaxel, pembrolizumab)Experimental Group · 7 Interventions: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Pembrolizumab, Nab-paclitaxel, BET Bromodomain Inhibitor ZEN-3694, Biopsy · Intervention Types: Procedure, Procedure, Procedure, Biological, Drug, Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~670
Computed Tomography
2017
Completed Phase 2
~3410
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Pembrolizumab
2017
Completed Phase 3
~2580
Nab-paclitaxel
2014
Completed Phase 3
~1680
Biopsy
2014
Completed Phase 4
~1120

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,000 Previous Clinical Trials
41,300,862 Total Patients Enrolled
3 Trials studying Breast
980 Patients Enrolled for Breast
Ana C Garrido-CastroPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The most recent sample with ER, PR and HER2 results will be used.
This criterion is met when patients have a negative primary or metastatic tumor tissue biopsy, but the tumor has a positive standard of care test for PD-L1.
You have unresectable locally advanced or metastatic disease.
Any number of prior lines of therapy are allowed in the metastatic setting
You have evaluable or measurable disease per RECIST 1.1 criteria.
Dose escalation in metastatic breast cancer patients treated with first-line systemic therapy is associated with improved survival.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.