A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1/2 study of ZN-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: K-Group Beta
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.