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Clinical Trial 21410

Cancer Type: Gynecological Tumor
Study Type: Treatment
NCT#: NCT04158336

Phase: Phase I
Principal Investigator: Chern, Jing-Yi

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Overview

Study Title

A Phase 1 Study of ZN-c3 as a Single Agent in Subjects with Solid Tumors

Summary

This is a Phase 1/2 open-label, multicenter study, evaluating the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics of ZN-c3 alone and in combination with other drugs.

Objective

Primary Dose Escalation: To investigate the safety and tolerability of single agent ZN-c3, including identification of the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D). Primary Dose Expansion: To investigate the clinical activity of WEE1 inhibition by ZN-c3 at RP2D based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 in subjects with uterine serous carcinoma and subjects with mutations of interest. Secondary: To obtain preliminary estimates of antitumor efficacy of single agent ZN-c3. To investigate the plasma pharmacokinetics (PK) of single agent ZN-c3.

Treatments

Therapies

Therapy (NOS)

Medications

Aloxi (Palonosetron); Aprepitant (); Dexamethasone (); Granisetron (); Netupitant (); Olanzapine (); Ondansetron (); Palonosetron (); Rolapitant (); ZN-c3 (); Zofran (Ondansetron)

Inclusion Criteria

Inclusion Criteria:

  • Provide written informed consent
  • 18 years of age or older
  • ECOG performance status > Adequate hematologic and organ function as defined in protocol.
  • Female patients of childbearing potential must have a negative serum beta human chorionic gonadotropin test.
  • Male and female patients of childbearing potential must agree to use an effective method of contraception from the start of the screening period and for 90 days after the last dose of ZN-c3.
  • Measurable or evaluable disease per RECIST version 1.1.
  • Individuals must meet these additional criteria in order to be eligible to participate in Phase 2 Single Agent part of the study:
  • ECOG performance status ≤ 1.
  • Measurable disease per RECIST version 1.1. Individuals must meet these additional criteria in order to be eligible to participate in Phase 2 combination with a PARP inhibitor:
  • ECOG performance status ≤ 1.
  • Measurable disease per RECIST version 1.1. Individuals must meet these additional criteria in order to be eligible to participate in Phase 2 combination with a PD-1 inhibitor:
  • ECOG performance status ≤ 1.
  • Measurable disease per RECIST version 1.1.
  • Additional criteria apply

  • Exclusion Criteria

    Key Exclusion Criteria:

  • Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:
  • Major surgery within 28 days.
  • Any chemotherapy within 21 days or 5 half-lives
  • Radiation therapy within 21 days; however, if the radiation portal covered > Autologous or allogeneic stem cell transplant within 3 months.
  • Current use of any other investigational drug therapy within 28 days or 5 half lives (whichever is shorter).
  • Inability to discontinue treatment with prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements that are strongand moderate CYP3A inhibitors and inducers or P-gp inhibitors at least 14 days prior to Cycle 1 Day 1.
  • A serious illness or medical condition(s) including, but not limited to, the following: a. Brain metastases that require immediate treatment or are clinically or radiologically unstable (ie, have been stable for > Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding ≤Grade 2 neuropathy, alopecia, or skin pigmentation).
  • Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN-c3 in class or any inactive ingredients present in ZN-c3 (see Pharmacy Manual).
  • Prior therapy with a WEE1 inhibitor.
  • Pregnant or lactating females or females of childbearing potential who have a positive serum pregnancy test within 14 days prior to Cycle 1 Day 1.
  • Patients with active (uncontrolled, metastatic) second malignancies or requiring therapy.
  • Individuals who are judged by the Investigator to be unsuitable as study subjects.
  • 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 msec, except for subjects with atrioventricular pacemakers or other conditions (eg, right bundle branch block) that render the QT measurement invalid.
  • History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes (TdP).
  • Other exclusions may apply

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.