Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemac… (NCT05372640) | Clinical Trial Compass
RecruitingPhase 1
Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors
United States45 participantsStarted 2023-08-10
Plain-language summary
This phase I trial tests the safety, side effects, and best dose of ZEN003694 when given together with abemaciclib in treating patients with NUT carcinoma, breast cancer or other solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ZEN003694 and abemaciclib may help shrink or stabilize cancer in patients with NUT carcinoma, breast cancer or other solid tumors.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* Dose Escalation Cohort Only: Participants must have evaluable disease or measurable disease per RECIST 1.1 criteria
* Dose Expansion Cohort Only:
* Participants must have a diagnosis of NUT carcinoma (NC) based on standard criteria for the disease, with diagnostic testing performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory:
* Ectopic expression of NUT protein per World Health Organization (WHO) criteria as determined by immunohistochemistry (IHC) testing, OR
* Detection of the NUT gene translocation as determined by fluorescence in situ hybridization (FISH) testing, OR
* Detection of the NUT gene translocation as determined by either deoxyribonucleic acid (DNA) next-generation sequencing (NGS) or ribonucleic acid (RNA) sequencing.
* Participants must have measurable disease per RECIST 1.1 criteria
* Any number of prior lines of therapy in the metastatic setting are allowed, including prior BET inhibitor therapy and prior CDK4/6 inhibitor therapy
* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] grade =\< 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy
* Patients who received radiotherapy must have compl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial still working out the safest dose of ZEN003694 combined with abemaciclib, what does that mean for what's currently known — and not yet known — about the safety and side effects of this specific combination for someone in my situation?
2This trial includes both adults and teenagers as young as 12 across several different cancer types, including NUT carcinoma and breast cancer — given my specific diagnosis and stage, do you think my situation is a good fit for what this study is designed to test?
3The trial is measuring things like overall response rate and progression-free survival during the dose expansion phase, but it's still Phase 1 — does that mean the main goal right now is figuring out safety rather than proving the treatment works, and how should I weigh that against pursuing standard treatment options first?
4Are there standard treatments I haven't yet tried that might be worth considering before enrolling in a Phase 1 study like this, or is my situation one where this trial could be a reasonable path to discuss now?
5What would my treatment schedule actually look like if I joined this trial — how often would I need to come in for visits, monitoring, and evaluations, and is that realistic given my current health and day-to-day life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose or recommended phase 2 dose (Phase I dose escalation)
Timeframe: During the first cycle of therapy (28 days)
2
Incidence of adverse events (Phase I dose expansion)
Timeframe: Up to 5 years
3
Overall response rate (Phase I dose expansion)
Timeframe: Up to 5 years
4
Clinical benefit rate (CBR) (Phase I dose expansion)
Timeframe: Up to 5 years
5
Duration of response (DoR) (Phase I dose expansion)
Timeframe: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years
6
Time to response (Phase I dose expansion)
Timeframe: From the time initiation of therapy to the time measurement criteria are met for CR or PR (whichever is first recorded), assessed up to 5 years