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Ovarian CancerPhase 2NCT05071937

ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer

A Phase 2 study testing ZEN003694 and Talazoparib in people with Ovarian Cancer and Peritoneal Cancer, run by Alexander B Olawaiye, MD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This Phase 2, open label, study with safety lead in of oral talazoparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with recurrent ovarian, fallopian tube or primary peritoneal carcinoma. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
ZEN003694 and Talazoparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
21 Apr 2023to 31 Dec 2034
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females age ≥ 18 years (at time of signing informed consent)
  • ECOG status 0 or 1
  • Pathologically documented ovarian, fallopian tube, or primary peritoneal carcinoma.
  • Prior therapy with PARPi either as maintenance or therapeutic settings.
  • All recurrent ovarian cancer both platinum sensitive and platinum resistant are allowed.
  • Any prior number of cancer therapy regimens
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  • Measurable disease per RECIST 1.1
  • Known BRCA1/2 status
  • Adequate laboratory parameters at Screening including:
  • Hemoglobin ≥ 9.0 gm/dL without transfusions during the 4 weeks prior to Screening
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
  • Platelet count ≥ 150,000/mm3
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.0 x ULN or if liver function abnormalities due to liver metastases AST and ALT ≤ 5.0 x ULN
  • Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN for subjects with known Gilbert's syndrome)
  • Serum Creatinine ≤ 1.5 X ULN
  • Prothrombin time (PT), international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN
  • Female subjects may be enrolled if they are not of childbearing potential, permanently sterile or who are post-menopausal, defined as no menses for at least 1 year without an alternative medical cause and FSH levels in the post-menopausal range. Female subjects of childbearing potential may be enrolled if they consistently and correctly use a highly effective form of contraception. Highly effective forms of contraception include: combined (estrogen and progestogen hormonal contraceptives (oral, intravaginal, transdermal) associated with inhibition of ovulation; progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence. Female subjects should not donate eggs from the time point of study drug administration until at least 7 months thereafter
  • Females of childbearing potential must have a negative serum pregnancy test before the first dose of study drug and must agree to serum pregnancy tests during the study.
  • Females may not be breast-feeding at the first dose of study drug, during study participation or through 7 months after the last dose of study drug.
  • Ability to swallow capsules and comply with study procedures.
  • Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures.
  • Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable with evidence of no disease progression for 6 months.

Who cannot join

  • Current or anticipated use of medications known to be strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows. Strong inhibitors, inducers or substrates must be discontinued at least 7 days prior to the first administration of study drug.
  • Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors.
  • Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed
  • Radiation to >25% of the bone marrow
  • Treatment with a bone-targeted radionuclide within 6 weeks of first dose of study drug
  • Prior chemotherapy or radiation within 3 weeks of study enrollment
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  • Have previously received an investigational BET inhibitor (including previous participation in studies with Zenith drug, ZEN003694)
  • QTcF interval > 470 msec
  • Insufficient recovery from prior treatment-related toxicities except for alopecia, fatigue and Grade 2 neuropathy
  • Non-healing wound, ulcer or bone fracture (not including a pathological bone fracture caused by a pre-existing pathological bone lesion)
  • Brain metastases not adequately treated and/or clinically stable (at the discretion of the Investigator) for at least 6 months prior to the start of study treatment.
  • Patients with ovarian carcinosarcoma
  • Known impaired cardiac function or clinically significant cardiac disease such as uncontrolled supraventricular arrhythmia, ventricular arrhythmia requiring therapy, or congestive heart failure (New York Heart Association functional class III or IV)
  • Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug
  • Known myelodysplastic syndrome
  • Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, or any other condition that could compromise safety or the patient's participation in the study
  • Impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 or talazoparib
  • Other known active cancer requiring therapy at time of study entry or that progressed or required treatment within 3 years prior to starting study drug (except for skin basal cell carcinoma or squamous cell carcinoma or in situ cervical cancer)
  • History of infection with (screening tests not required): human immunodeficiency virus; hepatitis B virus with currently active disease defined as hepatitis B surface antigen (HBsAg) positivity; or hepatitis C virus unless previously treated and viral load is undetectable except following situations:
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment are eligible for this trial.
  • Patients with a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection are allowed to be included if: participant on a stable dose of antiviral therapy, HBV viral load below the limit of quantification. HCV viral load below the limit of quantification.
  • Major surgery other than diagnostic surgery, dental surgery or stenting within 4 weeks prior to the first administration of study drug
  • Concurrent participation in another clinical investigational treatment trial
  • Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kelsey Mitch, BSN contact

412-648-6417

adamikka2@upmc.edu

Lucia Borasso, BSN contact

412-641-3304

borrlm@upmc.edu

United States1 site, 1 recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Kelsey Mitch, BSN, 4126412357, adamikka2@upmc.edu

    Lucia Borasso, BSN, 412-641-3304, borrlm@upmc.edu

    Recruiting

Other trials in United States

About this study

Official title: Phase ll Study of a BET Inhibitor, ZEN003694, Combined With a PARP Inhibitor, Talazoparib, in Patients With Recurrent Ovarian Cancer

This Phase 2, open label, study with safety lead in of oral talazoparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with recurrent ovarian, fallopian tube or primary peritoneal carcinoma.

Read the detailed description

This study aims to determine how effective the combination of ZEN003694 and talazoparib is based on how patients respond. ZEN003694 (and developed by Zenith Epigenetics Ltd.) has shown promising activity in the treatment of solid tumors and hematologic (blood) cancers by reducing the multiplication of cancer cells. Talazoparib is an extremely effective drug being developed for the treatment of a variety of human cancers. Talazoparib kills cancer cells by inhibiting and trapping the enzyme PARP, which is known to be involved in the development of many types of cancers. These two drugs are not FDA approved in the treatment of ovarian cancer.

Being tested
ZEN003694, Talazoparib
Keywords
PARP enzyme, bromodomain and extra terminal domain (BET) proteins
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

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

  • ZEN003694Drug

    ZEN003694 has shown promising activity in the treatment of solid tumors and hematologic (blood) cancers by reducing the multiplication of cancer cells.

  • TalazoparibDrug

    Talazoparib kills cancer cells by inhibiting and trapping the enzyme PARP, which is known to be involved in the development of many types of cancers.

Study groups in NCT05071937
Study groupRoleWhat they receive
ZEN003694 + TalazoparibExperimentalZEN003694: 48.0 mg daily (oral) in 28-day cycles Talazoparib: 0.75 mg daily (oral) at the same time as ZEN003694
Receives: Drug: ZEN003694; Drug: Talazoparib

What is being measured

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

  1. Objective Response

    Confirmed complete response or partial response by RECIST 1.1. Per RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to 48 months

Secondary outcomes (4)

  1. Adverse events at least possibly related to treatment

    Adverse Events which occur from first day of treatment, characterized by type, grade and relatedness to treatment according to CTCAE v5.0, considered to be possibly, probably or definitely related to study treatment.

    Measured: Up to 48 months

  2. Duration of Response

    Time from start of response to documented disease progression by RECIST v1.1 or death due to any cause. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions:

    Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

    Measured: Up to 48 months

  3. Progression-free survival (PFS)

    Time from first response to to treatment until documented disease progression by RECIST v1.1 or death due to any cause. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions:

    Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

    Measured: Up to 6 years

  4. Overall survival (OS)

    Overall survival (OS), defined as time from first dose of study treatment until death due to any cause.

    Measured: Up to 6 years

Timeline

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

  1. First posted8 Oct 2021
  2. Study start21 Apr 2023
  3. Primary completion30 Nov 2033 (estimated)
  4. Study completion31 Dec 2034 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05071937
Sponsor's protocol ID
HCC 21-091
Status last verified
Jun 2026
First submitted
27 Sep 2021
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZEN003694 and Talazoparib in people with Ovarian Cancer and Peritoneal Cancer, run by Alexander B Olawaiye, MD at 1 site 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 22 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Kelsey Mitch, BSN (412-648-6417, adamikka2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response (time frame: Up to 48 months). 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 NCT05071937.

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 18 Jun 2026.

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