A Phase 1 interventional study of Azenosertib and Gemcitabine in Osteosarcoma, sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. Completed at 17 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Phase 1, Interventional, and Treatment
This is a phase 1/2 study of azenosertib (ZN-c3) in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.
This is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical activity and safety, pharmacodynamics, and pharmacokinetics of azenosertib (ZN-c3) in combination with gemcitabine in relapsed or refractory osteosarcoma.
Exclusion Criteria:
Azenosertib (ZN-c3) in combination with Gemcitabine
Drug: Azenosertib · Drug: Gemcitabine
Azenosertib is an investigational drug.
Also known as: ZN-c3
Gemcitabine is an approved drug
Also known as: Gemzar
Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events.
Time frame: Through Cycle 1 (21 days) Phase 1
Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1.
EFS at 18 weeks is defined as time from study enrollment until date of disease progression, or detection of disease at a previously uninvolved site, or date of death of the subjects at 18 weeks.
Time frame: During phase 2, at 18 weeks
Event-free survival (EFS) per RECIST Guideline version 1.1.
EFS is defined as time from study enrollment until date of last contact, date of disease progression, or detection of disease at a previously uninvolved site, or date of death.
Time frame: At 12 months
Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1.
OS is defined as the time from date of first dosing until the date of death.
Time frame: At 12 months
The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities.
Time frame: Through completion, approximately 42 months
Plasma pharmacokinetics (PK) maximum concentration (Cmax).
Time frame: Through completion, approximately 42 months
Plasma PK time to maximum concentration (Tmax).
Time frame: Through completion, approximately 42 months
Area under the plasma concentration versus timepoint curve (AUC last).
Time frame: Through completion, approximately 42 months
Terminal half-life of the plasma PK concentration.
Time frame: Through completion, approximately 42 months
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc