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A Study of ZN-c3 in Patients With Ovarian Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study of ZN-c3 in Patients With Ovarian Cancer

A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer

NCT04516447•K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3 in combination with other drugs.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed high-grade serous epithelial ovarian carcinoma, fallopian tube, or peritoneal carcinoma.
•Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting.
•Measurable disease per RECIST version 1.1.
•Adequate hematologic and organ function as defined by the following criteria:
•1. ANC ≥ 1.5 × 10\^9/L; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim.
•2. Platelet count ≥ 100 × 10\^9/L; excluding measurements obtained within 3 days after transfusion of platelets or within 3 weeks after administration of platelet growth factors.
•3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastases, AST and ALT ≤ 5 x ULN.
•4. Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
•5. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.

Exclusion Criteria

•Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
•Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:
•1. Major surgery within 28 days.
•2. Radiation therapy within 21 days.
•3. Autologous or allogeneic stem cell transplant within 3 months.
•A serious illness or medical condition(s) including, but not limited to, the following:
•1. Brain metastases that require immediate treatment or are clinically or radiographically unstable.
•2. Myocardial impairment of any cause.
•3. Significant gastrointestinal abnormalities.
•4. Active or uncontrolled infection.
+2 more criteria

Locations (24)

Site 0264

Aurora, Colorado, United States

Site 0104

Boston, Massachusetts, United States

Site 0111

St Louis, Missouri, United States

Site 0173

New York, New York, United States

Site 0259

Durham, North Carolina, United States

Site 0191

Providence, Rhode Island, United States

Site 0196

Nashville, Tennessee, United States

Site 0103

Houston, Texas, United States

Site 2707

South Brisbane, Queensland, Australia

Site 2708

Sunshine Coast, Queensland, Australia

Key Dates

Start Date

October 26, 2020

Primary Completion Date

December 31, 2024

Completion Date

February 28, 2027

Last Updated

November 26, 2024

Enrollment

140

ESTIMATED participants

Conditions

Solid TumorEpithelial Ovarian CancerFallopian Tube CancerPeritoneal Cancer

Interventions

ZN-c3

DRUG

Carboplatin

DRUG

Pegylated liposomal doxorubicin

DRUG

Paclitaxel

DRUG

Gemcitabine

DRUG

Bevacizumab

BIOLOGICAL

Contacts

K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals

CONTACT

8582634333 medicalaffairs@zentalis.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ZN-c3 in Patients With Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

A Study of PYX-201 in Advanced Solid Tumors

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