A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma
- Age ≥ 12 years at the time of informed consent
- Bodyweight ≥ 40 kg
- Histologically documented relapsed or metastatic osteosarcoma.
- Must have measurable disease according to RECIST Guideline version 1.1 criteria.
- Adequate hematologic and organ function.
- Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Unresolved toxicity of Grade >1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation)
- Prior therapy with a WEE1 inhibitor
- A serious illness or medical condition(s).
- Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test <14 days to 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 >470 ms, 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 or family history of long QT syndrome or Torsades de Pointes (TdP).
- Taking medications with a known risk of TdP.
- Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors.
This is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical
activity and safety, pharmacodynamics, and pharmacokinetics of ZN-c3 in combination with
gemcitabine in relapsed or refractory osteosarcoma.
Trial Phase Phase I/II
Trial Type Treatment
- Primary ID ZN-c3-003
- Secondary IDs NCI-2021-03407
- Clinicaltrials.gov ID NCT04833582