A PHASE 1b STUDY OF ZN-c3 IN COMBINATION WITH CHEMOTHERAPY OR BEVACIZUMAB IN SUBJECTS WITH OVARIAN, PERITONEAL, OR FALLOPIAN TUBE CANCER

ENROLLING
Protocol # :
21-580
Conditions
Solid Tumor
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Phase
I
Disease Sites
Ovary
Principal Investigator
Liu, Joyce, F
Site Research Nurses
Belavusava, Vera
Bowes, Brittany, N.
Doherty, Kelsie
Hindenach, Sarah
McNamara, Taylor
Morrissey, Stephanie, C.
Neals, Allison
Thistle, Katrina, M.

Trial Description

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 Requirements

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.

21-580