ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer

NCT05071937 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HCC 21-091
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Keywords

PARP enzyme; bromodomain and extra terminal domain (BET) proteins

Outcome Measures

Primary Outcomes (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.

  Up to 48 months

Secondary Outcomes (4)

• Adverse events at least possibly related to treatment

  Up to 48 months

• Duration of Response

  Up to 48 months

• Progression-free survival (PFS)

  Up to 6 years

• Overall survival (OS)

  Up to 6 years

Study Arms (1)

ZEN003694 + Talazoparib

EXPERIMENTAL

ZEN003694: 48.0 mg daily (oral) in 28-day cycles Talazoparib: 0.75 mg daily (oral) at the same time as ZEN003694

Drug: ZEN003694; Drug: Talazoparib

Interventions

ZEN003694 DRUG

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

ZEN003694 + Talazoparib

Talazoparib DRUG

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.

ZEN003694 + Talazoparib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Alexander B Olawaiye, MD: lead
• Pfizer: collaborator
• Zenith Epigenetics: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

talazoparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Alexander B Olawaiye, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey Mitch, BSN

CONTACT

412-648-6417; adamikka2@upmc.edu

Lucia Borasso, BSN

CONTACT

412-641-3304; borrlm@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Obstetrics, Gynecology & Reproductive Sciences

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 8, 2021
• Study Start: April 21, 2023
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): March 1, 2033
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)