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CDK4/6 Inhibitor

ZEN003694 + Abemaciclib for Cancer

Phase 1

Recruiting

Led By Jia Luo

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

Dose Expansion Cohort Only: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN for age

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial tests safety and best dose of a drug combo for treating metastatic or unresectable cancer. ZEN003694 and abemaciclib may prevent growth of tumor cells.

Who is the study for?

This trial is for adults and kids aged 12-17 with NUT carcinoma or other solid tumors that have spread or can't be surgically removed. Participants need to meet specific health criteria, like normal organ function tests, controlled HIV or hepatitis if present, and a certain level of physical fitness. They should not have untreated brain metastases or conditions that could affect the trial's results.Check my eligibility

What is being tested?

The trial is testing the combination of two drugs: ZEN003694 (a BET protein growth inhibitor) and abemaciclib (an enzyme blocker stopping tumor cell growth). It aims to find the safest dose that might help shrink or stabilize these cancers. The study includes biospecimen collection, imaging, and biopsies.See study design

What are the potential side effects?

Possible side effects from ZEN003694 and abemaciclib may include fatigue, nausea, liver issues, blood count changes leading to infection risk increase or bleeding problems. There might also be risks related to taking pills and potential unknown effects on unborn babies.

Eligibility Criteria

Inclusion Criteria

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

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My liver enzymes are within the normal range for my age.

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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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I have been diagnosed with NUT carcinoma confirmed by specific lab tests.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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I am 16 or older and can care for myself, or if under 16, I can do most activities.

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My brain metastases have been treated, stable for 1 month, and show no signs of getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Clinical benefit rate (CBR) (Phase I dose expansion)

Duration of response (DoR) (Phase I dose expansion)

Incidence of adverse events (Phase I dose expansion)

+5 more

Secondary outcome measures

Pharmacokinetics (PK)

Thymidine

Other outcome measures

Analysis of ATAC-sequence data

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ZEN003694, abemaciclib)Experimental Treatment5 Interventions

Patients receive ZEN003694 PO QD on days 1-28 or 5 days on and 2 days off, and abemaciclib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo imaging evaluation, blood sample collection and tumor biopsy throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1700