A Study to Evaluate the clinical activity and safety of ZN-c3 in Combination with Gemcitabine in Adult and Pediatric Subjects with Relapsed or Refractory Osteosarcoma

Phase 1

• Conditions: Relapsed or Refractory Osteosarcoma; MedDRA version: 20.0Level: HLTClassification code 10039498Term: Bone sarcomasSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000021-27-ES
• Lead Sponsor: K-Group Beta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-13
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1.Age =12 years old at the time of informed consent.
2.Body weight =40 kg.
3.Histologically documented relapsed or metastatic osteosarcoma, as confirmed at the local study site.
a)The disease must have failed standard therapy and there is no known curative therapy available, or any available standard of care therapy was not tolerated or was refused by the subject.
b)The Investigator must confirm that gemcitabine is an appropriate treatment approach.
c)Subjects may have had any number of prior therapies and prior treatment with gemcitabine is allowed.
4.Must have measurable disease according to RECIST Guideline version 1.1 criteria.
5.Adequate hematologic and organ function.
6.Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception prior to the first dose and for 6 months after the last dose of ZN-c3 and/or gemcitabine.
7.Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 26
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1.Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade =2 neuropathy, alopecia, or skin pigmentation).
2.Prior therapy with a WEE1 inhibitor.
3.A serious illness or medical condition(s).
4.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.
5.Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
6.12-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.
7.History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP).
8.Taking medications with a known risk of TdP.
9.Administration of strong and moderate CYP3A4 inhibitors and inducers and P-gp inhibitors.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified