OsteosarcomaPhase 1NCT04833582
A Study of Azenosertib (ZN-c3) in Combination With Gemcitabine in Subjects With Osteosarcoma
A Phase 1 study testing Azenosertib and Gemcitabine in people with Osteosarcoma, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 17 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Azenosertib and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 1 Aug 2021to 30 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States12 sites
Site 0107
Cincinnati, Ohio, 45229
University of Florida College of Medicine
Gainesville, Florida, 32610
Site 0103
Houston, Texas, 77030
Site 0106
Los Angeles, California, 90095
Site 0193
Memphis, Tennessee, 38105
Site 0197
Nashville, Tennessee, 37332
Site 0105
New York, New York, 10065
Site 0124
Oakland, California, 94609
Site 0123
Portland, Oregon, 97239
Site 0188
Richmond, Virginia, 23298
Site 0195
Santa Monica, California, 90403
Site 0122
Seattle, Washington, 98195
France5 sites
Site 3604
Bordeaux, 33000
Site 3601
Lyon, 69008
Site 3602
Marseille, 13385
Site 3606
Paris, 75248
Site 3605
Toulouse, 31100
About this study
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
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.
Read the detailed description
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.
- Conditions
- Osteosarcoma
- Being tested
- Azenosertib, Gemcitabine
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzenosertibDrug
Also called ZN-c3
Azenosertib is an investigational drug.
GemcitabineDrug
Also called Gemzar
Gemcitabine is an approved drug
| Study group | Role | What they receive |
|---|---|---|
| Azenosertib in combination with Gemcitabine | Experimental | Azenosertib (ZN-c3) in combination with Gemcitabine Receives: Drug: Azenosertib; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events.
Measured: 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.
Measured: During phase 2, at 18 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: Through completion, approximately 42 months
Plasma pharmacokinetics (PK) maximum concentration (Cmax).
Measured: Through completion, approximately 42 months
Plasma PK time to maximum concentration (Tmax).
Measured: Through completion, approximately 42 months
Area under the plasma concentration versus timepoint curve (AUC last).
Measured: Through completion, approximately 42 months
Terminal half-life of the plasma PK concentration.
Measured: Through completion, approximately 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Aug 2021
- Primary completion30 Aug 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833582
- Sponsor's protocol ID
- ZN-c3-003
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2021
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04833582
- Acronym / sponsor ID
- ZN-c3-003
- Conditions
- Osteosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azenosertib in combination with Gemcitabine | Experimental | Drug: Azenosertib, Drug: GemcitabineAzenosertib (ZN-c3) in combination with Gemcitabine |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzenosertibAlso: ZN-c3Azenosertib is an investigational drug. | Drug | Azenosertib in combination with Gemcitabine |
| GemcitabineAlso: GemzarGemcitabine is an approved drug | Drug | Azenosertib in combination with Gemcitabine |
Primary outcome
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.
Time frame: During phase 2, at 18 weeks
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.
7 secondary outcomes
Event-free survival (EFS) per RECIST Guideline version 1.1.
Time frame: At 12 months
Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azenosertib and Gemcitabine in people with Osteosarcoma, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.