AzTrials
AzTrials

Metastatic Malignant Solid NeoplasmPhase 1NCT04840589

Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors

A Phase 1 study testing BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure and Biospecimen Collection in people with Metastatic Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, run by National Cancer Institute (NCI) at 9 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial summary

This phase I/Ib trial is to find out the best dose, possible benefits and/or side effects of BET bromodomain inhibitor ZEN-3694 (ZEN003694) when given in combination with nivolumab with or without ipilimumab in treating patients with solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
9 sitesUnited States
Study dates
2 Feb 2022to 1 Sep 2028
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed metastatic or recurrent solid tumor malignancy for which standard curative or palliative measures do not exist or are no longer effective
  • Dose escalation/phase I: Metastatic or recurrent solid tumors with measurable or evaluable disease
  • Dose expansion exploratory cohorts (nivolumab + ipilimumab + ZEN003694): Recurrent BRCAwt epithelial ovarian carcinoma patients who have progressed or recurred within < 6 months from prior platinum-based therapy
  • Dose escalation and expansion exploratory cohorts: Patients must have measurable and biopsiable disease (at least two lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. For patients in the dose escalation with evaluable disease, biopsy is mandated if feasible
  • No more than 5 lines of prior therapy for the dose escalation and expansion phases
  • In the expansion cohorts, up to 2 prior lines in the platinum-resistant setting is allowed
Show all 27Show fewer
  • Patients with primary refractory ovarian cancer (who progressed while on primary 1L platinum therapy) will be excluded in the dose expansion cohorts but allowed in the dose escalation cohort
  • Patients who have had chemotherapy or radiotherapy more than 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and who have recovered from adverse events due to agents administered more than 4 weeks earlier are eligible; for oral therapies, a patient is eligible after 5 half-lives of the drug. Prior palliative (limited field) radiation therapy is permitted, if all of the following criteria are met:
  • Palliative radiation must have been completed at least 4 weeks before starting study treatment
  • Repeat imaging demonstrates no new sites of bone metastases
  • Irradiated sites of metastasis should not be selected as target lesions
  • Patients must have recovered to meet all eligibility criteria
  • Age >= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of nivolumab in combination with ZEN003694 +/- ipilimumab in patients < 18 years of age, children are excluded from this study
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)
  • Leukocytes >= 2,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 150,000/mcL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN
  • Creatinine clearance (CrCl) >= 60 mL/min (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better and have a corrected QT (QTc) interval < 450 msec
  • The effects of nivolumab, ZEN003694, and/or ipilimumab on the developing human fetus are unknown. For this reason and because nivolumab, ZEN003694, and/or ipilimumab are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP should use an adequate method to avoid pregnancy for 5 months after the last dose of investigational drug. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception.
  • WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
  • WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days.
  • Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible

Who cannot join

  • Patients with sarcoma or non-epithelial histology
  • Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to the first dose of study intervention
  • Prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Prior anti-PD-1/PD-L1 in microsatellite instability-high (MSI-H) tumors is allowed in the dose escalation cohort if no grade 2 or more toxicities developed during that therapy requiring stopping immune checkpoint inhibition. Patients who have received prior vaccine therapy are eligible
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, ipilimumab, and/or ZEN003694, including severe hypersensitivity reactions to any monoclonal antibody
  • Patients who are receiving any other investigational agents
  • Patients with human immunodeficiency virus (HIV) infection may be enrolled on this study provided: (a) they are on a stable regimen of highly active anti-retroviral therapy (HAART) with no medications otherwise prohibited by this protocol (e.g. drug-drug interactions,), e.g. medications cannot be CYP3A4 inducers or inhibitors and cannot interact with ZEN003694), and (b) they require no concurrent antibiotics or antifungals for the prevention of opportunistic infections, and (c) they have a CD4 count above 250 cell/mcL and an undetectable viral load on standard polymerase chain reaction (PCR)-based tests within 1 month of initiation of study treatment
Show all 18Show fewer
  • Other patients with clinically significant immunosuppression, e.g. organ transplant patients, are not eligible. If clarification is needed, this may be discussed with the medical monitor. Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
  • Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if =< 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted
  • Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study
  • Patients with known immune impairment who may be unable to respond to anti-CTLA-4 antibody
  • Bowel obstruction or any condition precluding oral intake. No gastric tube for venting purposes. No significant gastrointestinal disease or fistula
  • Known active hepatitis infections or active infections require IV systemic antibiotics
  • Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 or that receive fluoxetine (moderate CYP2C19 inhibitor with a metabolite that potentially causes CYP3A4 inhibition) are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
  • Patients with uncontrolled intercurrent illness
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements
  • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (>= New York Heart Association Classification class II), or serious cardiac arrhythmia requiring medication
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: breast cancer in situ, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
  • Pregnant women are excluded from this study because nivolumab and ipilimumab are immunotherapeutic agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nivolumab and ipilimumab, breastfeeding should be discontinued if the mother is treated with nivolumab and ipilimumab. These potential risks may also apply to other agents used in this study

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • National Cancer Institute Developmental Therapeutics Clinic

    Bethesda, Maryland, 20892

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Mount Sinai Hospital

    New York, New York, 10029

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Phase I/Ib Trial Evaluating the Safety and Efficacy of BET Inhibitor, ZEN003694 With PD-1 Inhibitor, Nivolumab With or Without CTLA-4 Inhibitor, Ipilimumab in Solid Tumors

This phase I/Ib trial is to find out the best dose, possible benefits and/or side effects of BET bromodomain inhibitor ZEN-3694 (ZEN003694) when given in combination with nivolumab with or without ipilimumab in treating patients with solid tumors. ZEN003694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ZEN003694 in combination with nivolumab with or without ipilimumab may shrink or stabilize solid tumors.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the safety/tolerability and recommended phase 2 dose (RP2D) of the BET inhibitor (BETi) ZEN003694 when combined with nivolumab with or without low dose ipilimumab in solid tumors.

SECONDARY OBJECTIVES:

  1. To evaluate the efficacy of the triplet regimen in a cohort of patients with recurrent platinum-resistant BRCA wild type (wt) epithelial ovarian cancer.

Ia. To observe and record anti-tumor activity. II. To evaluate the impact of BET inhibition on the tumor immune microenvironment (TIME).

III. To explore predictors of response and resistance to therapy. IV. To characterize the pharmacokinetic (PK) profile of ZEN003694 and its active metabolite ZEN003791.

EXPLORATORY OBJECTIVE:

  1. To correlate drug exposure with response and/or toxicity.

OUTLINE: This is a dose-escalation study of ZEN003694 followed by a dose-expansion study.

DOSE ESCALATION (DOUBLET TREATMENT): Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and ZEN003694 orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI), a computed tomography (CT) scan, a positron emission tomography (PET) scan, and/or an x-ray as well as blood sample collection throughout the trial. Patients also undergo a biopsy during screening.

DOES ESCALATION AND DOSE EXPANSION (TRIPLET TREATMENT): Patients receive nivolumab IV over 30 minutes on day 1, ipilimumab IV over 90 minutes on day 1, and ZEN003694 PO QD on days 1-21 or 1-28 of each cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 5, patients are no longer treated with ipilimumab, but receive nivolumab IV over 30 minutes on day 1 and ZEN003694 PO QD on days 1-21 or 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, a CT scan, a PET scan, and/or an x-ray as well as blood sample collection throughout the trial. Patients also undergo a biopsy during screening and on study.

After completion of study treatment, patients are followed up for 30 days, then every 3 months for 1 year.

Being tested
BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Ipilimumab
Medical subject headings
Neoplasm Metastasis, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BET Bromodomain Inhibitor ZEN-3694Drug

    Also called BETi ZEN-3694, ZEN 3694, ZEN-3694, ZEN003694

    Given PO

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo a biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo a CT scan

  • IpilimumabBiological

    Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • NivolumabBiological

    Also called ABP 206, BCD-263, BMS 936558, BMS-936558

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo a PET scan

  • X-Ray ImagingProcedure or surgery

    Also called Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs

    Undergo x-ray

Study groups in NCT04840589
Study groupRoleWhat they receive
Doublet treatment (ZEN003694, nivolumab)ExperimentalPatients receive nivolumab IV over 30 minutes on day 1 and ZEN003694 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, a CT scan, a PET scan, and/or an x-ray as well as blood sample collection throughout the trial. Patients also undergo a biopsy during screening.
Receives: Drug: BET Bromodomain Inhibitor ZEN-3694; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Procedure: Positron Emission Tomography; Procedure: X-Ray Imaging
Triplet treatment (nivolumab, ZEN003694, ipilimumab)ExperimentalPatients receive nivolumab IV over 30 minutes on day 1, ipilimumab IV over 90 minutes on day 1, and ZEN003694 PO QD on days 1-21 or 1-28 of each cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 5, patients are no longer treated with ipilimumab, but receive nivolumab IV over 30 minutes on day 1 and ZEN003694 PO QD on days 1-21 or 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, a CT scan, a PET scan, and/or an x-ray as well as blood sample collection throughout the trial. Patients also undergo a biopsy during screening and on study.
Receives: Drug: BET Bromodomain Inhibitor ZEN-3694; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Ipilimumab; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Procedure: Positron Emission Tomography; Procedure: X-Ray Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability

    Will calculate maximum tolerated dose and dose limiting toxicity with dose escalation using standard 3+3 design.

    Measured: Up to 1 cycle of treatment for doublet group (4 weeks) and up to 2 cycles for triplet group (6 weeks)

  2. Phase 2 recommended dose for the combined regimens

    Measured: Up to 1 cycle of treatment for doublet group (4 weeks) and up to 2 cycles for triplet group (6 weeks)

Secondary outcomes (13)

  1. Objective response rate (ORR)

    Defined as partial or complete response to the combined regimens in the entire cohort and in the expansion cohort. Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) only. All treatment decisions should be made by RECIST v1.1 only.

    Measured: Up to 1 year post-treatment

  2. Progression-free survival

    Measured: Up to 1 year post-treatment

  3. Overall survival

    Measured: Up to 1 year post-treatment

  4. Incidence of adverse events

    Will include grade 3 and 4 immune and non-immune events assessed by Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 1 year post-treatment

  5. Clinical benefit

    Defined as ORR and stable disease.

    Measured: Up to 1 year post-treatment

  6. Whole exome sequencing

    Will assess: a) CCNE1, MYC, BRD4 status b) MSI status and tumor mutational burden c) B2M mutation/deficiency and alteration in antigen processing/presentation machinery (MHC1) d) Alteration in other molecular pathways such as HRD/BRCA, PI3K.

    Measured: Up to 1 year post-treatment

  7. Next generation sequencing ribonucleic acid sequencing

    Will assess: a) Functional CCNE1, MYC, BRD4 gene expression status at baseline and at 4 weeks b) Alteration in tumor immune microenvironment and immune markers/signature like interferon-gamma signature.

    Measured: Up to 1 year post-treatment

  8. PD-L1 expression in tumor cells and tumor-associated immune cells

    Measured: Up to 1 year post-treatment

  9. Multiplex analysis of tumor infiltrating immune cells

    Will assess immune cell subpopulations and their activation status.

    Measured: Up to 1 year post-treatment

  10. Pharmacokinetic (PK) parameters

    Individual PK parameters will be estimated, specifically maximum concentration, area under the concentration-time curve, half-life, apparent clearance, and apparent volume of distribution using non-compartmental methods. The PK variables will be tabulated and descriptive statistics (e.g., geometric means and coefficients of variation) calculated for each dose level. PK parameters will be reported descriptively for exploratory comparison with historical data.

    Measured: Pre dose, and then 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 h after dose on cycle 1, day 1; and pre dose and 1-3 hours post-dose on cycle 2, day 1

  11. Phenotypic characteristics of peripheral blood mononuclear cells over treatment

    Will compare these phenotypic characteristics to baseline to assess different immune cells subset and their activation status peripherally.

    Measured: At 4 weeks (cycle 2 day 1 of treatment)

  12. Circulating tumor deoxyribonucleic acid

    Assessed in plasma using TSO500 panel. Will assess: a) CCNE1, MYC, and BRD4 (if BRD4 became available) status at baseline and during treatment to assess if blood-based status is concordant with tissue based status and if the status changes during therapy b) Blood based molecular residual disease and tumor mutational burden.

    Measured: Up to 1 year post-treatment

  13. Pro-inflammatory and anti-inflammatory cytokines analyses

    Assessed in plasma.

    Measured: Up to 1 year post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2021
  2. Study start2 Feb 2022
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Why it stopped: Other - Pending amendment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04840589
Sponsor's protocol ID
NCI-2021-02850
Other IDs
NCI-2021-02850, HCC#21-211, 10433, 10433, UM1CA186690
Status last verified
Aug 2026
First submitted
9 Apr 2021
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Publications

  • Feng Y, Mahdi H, Piekarz R, Beumer JH, Synold TW. An LC-MS/MS method for determination of the bromodomain inhibitor ZEN-3694 and its metabolite ZEN-3791 in human plasma. Bioanalysis. 2024;16(8):227-238. doi: 10.4155/bio-2023-0252. Epub 2024 Mar 18.

    PubMed 38497709

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure and Biospecimen Collection in people with Metastatic Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, run by National Cancer Institute (NCI) at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: Up to 1 cycle of treatment for doublet group (4 weeks) and up to 2 cycles for triplet group (6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04840589, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in