ZN-c3 + Gemcitabine for Osteosarcoma

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: K-Group Beta

No Placebo Group

Trial Summary

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

Eligibility Criteria

This trial is for adults and kids over 12 with osteosarcoma that's come back or spread, who can measure their cancer using RECIST 1.1, have good blood and organ function, weigh at least 40 kg, and will use birth control. It's not for those with certain heart conditions, pregnant or breastfeeding women, people taking specific drugs affecting the body's drug processing system or those with other serious illnesses.

Inclusion Criteria

Bodyweight ≥ 40 kg

Age ≥ 12 years at the time of informed consent

Histologically documented relapsed or metastatic osteosarcoma

+4 more

Exclusion Criteria

History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP)

Pregnant or lactating females

Females of childbearing potential with a positive serum pregnancy test <14 days to Day 1

+7 more

Participant Groups

The study tests ZN-c3 combined with gemcitabine in patients whose osteosarcoma has either returned after treatment or hasn't responded to previous treatments. This phase 1/2 trial aims to find out how safe this combination is and how well it works against this type of bone cancer.

1Treatment groups

Experimental Treatment

Group I: Combination ZN-c3 with GemcitabineExperimental Treatment2 Interventions

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Gemzar for: