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A Study of ZN-c3 in Patients With Platinum-Resistant Ovarian Cancer

Trial Status: Active

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.

Inclusion Criteria

  • Provision of written informed consent prior to initiation of any study-related procedures that are not considered standard of care.
  • Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
  • ECOG performance status ≤ 2.
  • Histologically or cytologically confirmed high-grade serous epithelial ovarian carcinoma, fallopian tube, or peritoneal carcinoma.
  • Subjects must have received 1 or 2 prior chemotherapy regimens.
  • The disease must be platinum-resistant, i.e., the Platinum-Free Interval (PFI) must have been < 6 months. Platinum refractory disease, i.e., PD during first-line platinum-based therapy is allowed.
  • Measurable disease per RECIST version 1.1.
  • Adequate hematologic and organ function as defined by the following criteria:
  • 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.
  • Platelet count ≥ 100 × 10^9/L; excluding measurements obtained within 3 days after transfusion of platelets.
  • 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.
  • Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
  • Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.
  • Female subjects of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test and agree to use an effective method of contraception per institutional standard.
  • Left ventricular ejection fraction (LVEF) ≥ 50% or within normal limits of the institution (only for subjects treated with PLD).

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:
  • Major surgery within 28 days.
  • Radiation therapy within 21 days.
  • Autologous or allogeneic stem cell transplant within 3 months.
  • A serious illness or medical condition(s) including, but not limited to, the following:
  • Brain metastases that require immediate treatment or are clinically or radiologically unstable.
  • Leptomeningeal disease that requires or is anticipated to require immediate treatment.
  • Myocardial impairment of any cause.
  • Significant gastrointestinal abnormalities.
  • Active or uncontrolled infection.
  • Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding Grade 2 neuropathy, alopecia or skin pigmentation).
  • Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 14 days prior to Cycle 1 Day 1.
  • Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
  • 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of > 450 msec, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
  • History or current evidence of congenital long QT syndrome.
  • Taking medications that lead to significant QT prolongation.
  • Administration of strong and moderate CYP3A4 inhibitors and inducers as well as strong and moderate P-glycoprotein (P-gp) inhibitors.

Texas

Houston
M D Anderson Cancer Center
Status: APPROVED

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability,

preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3. This

study consists of 2 cohorts in participants with platinum-resistant ovarian, peritoneal, or

fallopian tube cancer. One cohort will test a combination of ZN-c3 and pegylated liposomal

doxorubicin (PLD), and the other cohort will test a combination of ZN-c3 and carboplatin.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
K-Group Beta

  • Primary ID ZN-c3-002
  • Secondary IDs NCI-2020-07262
  • Clinicaltrials.gov ID NCT04516447