Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Noah Federman
Headshot of Noah Federman
Noah Federman

Description

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.

Official Title

A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma

Details

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.

Keywords

Osteosarcoma, Gemcitabine

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Site 0106
    Los Angeles California 90095 United States
  • Site 0195
    Santa Monica California 90403 United States

Lead Scientist at UCLA

  • Noah Federman
    Dr. Noah Federman is the Director of the Pediatric Bone and Soft Tissue Sarcoma Program at UCLA, part of the UCLA Sarcoma Program and UCLA's Jonsson Comprehensive Cancer Center. Dr. Federman specializes in treating children, adolescents and young adults with these aggressive cancers.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
ID
NCT04833582
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 84 study participants
Last Updated