A Study of ZN-c3 in Patients With Ovarian Cancer

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04516447
• Other study ID #: ZN-c3-002
• Status: Recruiting
• Phase: Phase 1
• Start date: October 26, 2020
• Est. completion date: February 28, 2027

Study information

• Verified date: May 2024
• Source: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
• Contact: K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
• Phone: 8582634333
• Email: medicalaffairs[@]zentalis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: February 28, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

5. Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months prior to Cycle 1 Day 1, or recurrent paracentesis or thoracentesis within 6 weeks prior to Cycle 1 Day 1.

• Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Peritoneal Cancer
• Solid Tumor

Intervention

Drug:
• ZN-c3
Investigational drug
• Carboplatin
Carboplatin is an approved drug
• Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin (PLD) is an approved drug
• Paclitaxel
Paclitaxel is an approved drug
• Gemcitabine
Gemcitabine is an approved drug

Biological:
• Bevacizumab
Combined with azenosertib

Locations

Country	Name	City	State
Australia	Site 2709	Adelaide	South Australia
Australia	Site 2706	Melbourne	Victoria
Australia	Site 2705	Nedlands	Western Australia
Australia	Site 2707	South Brisbane	Queensland
Australia	Site 2708	Sunshine Coast	Queensland
Bosnia and Herzegovina	Site 1001	Banja Luka
Bosnia and Herzegovina	Site 1002	Sarajevo
Bosnia and Herzegovina	Site 1003	Tuzla
Bulgaria	Site 1202	Panagyurishte
Bulgaria	Site 1201	Sofia
Georgia	Site 1401	Tbilisi
Korea, Republic of	Site 2901	Busan
Korea, Republic of	Site 2903	Seoul
Korea, Republic of	Site 2904	Seoul
Serbia	Site 1902	Belgrade
United States	Site 0264	Aurora	Colorado
United States	Site 0104	Boston	Massachusetts
United States	Site 0259	Durham	North Carolina
United States	Site 0103	Houston	Texas
United States	Site 0196	Nashville	Tennessee
United States	Site 0173	New York	New York
United States	Site 0191	Providence	Rhode Island
United States	Site 0111	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Australia,  Bosnia and Herzegovina,  Bulgaria,  Georgia,  Korea, Republic of,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the safety and tolerability of ZN-c3 in combination with PLD, carboplatin, paclitaxel, gemcitabine, or bevacizumab	Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0	Through completion, approximately 40 months
Primary	To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of ZN-c3 in combination with PLD, carboplatin, paclitaxel, or gemcitabine	Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1	Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, gemcitabine, or bevacizumab)