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OsteosarcomaPhase 3NCT06935409

Study of HS-20093 Versus Gemcitabine in Combination With Docetaxel in Treatment of Osteosarcoma After Previous Second-line Treatment Failure

A Phase 3 study testing HS-20093 and Gemcitabine combined with docetaxel in people with Osteosarcoma, run by Hansoh BioMedical R&D Company at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, controlled, open, multicenter phase III clinical study to evaluate the efficacy and safety of HS-20093 for injection versus gemcitabine in combination with docetaxel in patients with osteosarcoma who have at least second-line treatment failure. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Osteosarcoma
What is being tested?
HS-20093 and Gemcitabine combined with docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
2 sitesChina
Study dates
25 Apr 2025to 7 Sep 2026
Phase
Phase 3
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

  • Males or females over 12 years old (≥ 12 years).
  • Pathologically confirmed osteosarcoma (key IHC/tumor cell phenotyping results required for a definitive diagnosis must be provided).
  • The study participants should have at least 1 target lesion based on RECIST 1.1.
  • An ECOG PS of 0 to 1, with no exacerbation within two weeks prior to first dosing.
  • A minimum expected survival of greater than 12 weeks.
  • Female study participants of childbearing potential must be willing to use appropriate contraceptive measures and refrain from breastfeeding from the signing of informed consent to six months after the last dosing or the end of treatment (whichever occurs later); male study participants must be willing to use barrier contraceptive measures (i.e., condoms) from the signing of informed consent to six months after the last dosing or the end of treatment (whichever occurs later).
  • Female study participants must provide negative blood or urine pregnancy test results within seven days before the first dosing, or meet one of the following criteria to prove there is no risk of pregnancy:
  • Voluntary participation in this clinical trial, and signing and dating of the written ICF approved by the IRB/IEC in accordance with regulatory, local, and institutional guidelines.

Who cannot join

  • Prior or ongoing therapies as follows:
  • Prior or current use of treatments targeting B7-H3
  • Prior or current use of treatments with topoisomerase I inhibitors, including antibody-drug conjugates that are effectively loaded with topoisomerase I inhibitors
  • Prior or current use of systemic anti-tumor therapy with gemcitabine in combination with docetaxel;
  • Use of cytotoxic chemotherapy drugs, experimental drugs, traditional Chinese medicines for anti-tumor indicationsor other anti-tumor drugs within 14 days prior to randomization; or requiring continued use of such drug therapies during the study;
  • Use of macromolecular anti-tumor drug therapy within 28 days prior to randomization;
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  • Presence of residual grade ≥ 2 toxicities by Common Terminology Criteria for Adverse Events (CTCAE version 5.0) from previous treatments.
  • History of other primary solid tumors.
  • Inadequate bone marrow reserve or liver and kidney organ function, which meets any of the following laboratory limits:
  • Serious, uncontrolled or active cardiovascular diseases.
  • Severe or poorly controlled diabetes, including: ① Diabetic ketoacidosis or hyperglycemia and hyperosmolarity within 6 months prior to randomization; or ② other severe or poorly controlled diabetes conditions as determined by the investigator.
  • Severe or poorly controlled hypertension, including: history of prior hypertensive crisis or hypertensive encephalopathy; adjustment of antihypertensive drug therapy within two weeks prior to randomization due to poor blood pressure control; systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg during the screening period.
  • Have clinically significant hemorrhage symptoms or significant hemorrhagic diathesis within 1 month before randomization.
  • Serious arteriovenous thrombotic events within 3 months before randomization, such as deep vein thrombosis, pulmonary embolism, etc. .
  • Severe infection within four weeks prior to randomization, including but not limited to complications of infection, bacteremia, or severe pneumonia requiring intravenous antibiotic therapy for ≥ 2 weeks; or uncontrollable active infection during the screening period. Study participants who are receiving or have received prophylactic antibiotics may be enrolled.
  • Patients who have received continuous glucocorticoid therapy for more than 30 days within 30 days before randomization, or who require long-term (≥ 30 days) use of glucocorticoids, or patients with other acquired/congenital immunodeficiency diseases or with a history of transplantation (except for corneal transplantation). Systemic corticosteroids (≤ 10 mg/d prednisone or equivalent) at a physiological replacement dose are permitted.
  • Known presence of infectious diseases, such as hepatitis B , hepatitis C, tuberculosis , syphilis, or HIV infection , etc. Active infectious diseases will not be screened for proactively.
  • Existing hepatic encephalopathy, hepatorenal syndrome, or ≥ Child-Pugh class B cirrhosis.
  • Known interstitial pneumonia or immune pneumonitis, other moderate-to-severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and severely affect respiratory function.
  • A history of prior serious neurological or psychiatric disorders, including epilepsy, dementia, severe depression, or other conditions that can interfere with the assessment.
  • Female patients who are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Vaccination or occurrence of any degree of allergic or hypersensitivity reaction within four weeks prior to the first dosing.
  • Subjects who have previously experienced severe allergies or serious infusion reactions, or who are allergic to recombinant humanized or murine protein substances.
  • ‬Allergies to any component of the study drug HS-20093 , gemcitabine and its excipients, and docetaxel and its excipients.
  • Patients who may have poor compliance with the study procedures and requirements as judged by the investigator.
  • Patients with any condition that, in the Investigator's judgment, jeopardizes their safety or interferes with study assessments.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Jishuitan Hospital affiliated to Capital Medical University

    Beijing

  • Peking University People's Hospital

    Beijing

Other trials in China

About this study

Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of HS-20093 for Injection Versus Gemcitabine in Combination With Docetaxel in the Treatment of Osteosarcoma After Previous Second-line Treatment Failure (ARTEMIS-011)

This is a randomized, controlled, open, multicenter phase III clinical study to evaluate the efficacy and safety of HS-20093 for injection versus gemcitabine in combination with docetaxel in patients with osteosarcoma who have at least second-line treatment failure.

Read the detailed description

This is a randomized, controlled, open-label, multicenter phase III clinical study to evaluate the efficacy and safety of HS-20093 for injection versus gemcitabine in combination with docetaxel in patients (≥ 12 years old) with osteosarcoma who have at least second-line treatment failure.

Eligible study participants shall be randomized in a 2:1 ratio to the experimental group and the control group. Study participants in the experimental group received HS-20093 at 12.0 mg/kg once every 3 weeks (Q3W), and the study participants continued to receive treatment until objective disease progression or other criteria for treatment discontinuation were met. Study participants in the control group received standard chemotherapy regimen of gemcitabine in combination with docetaxel until disease progression or other criteria for treatment discontinuation were met. The efficacy and safety of the two groups were evaluated after follow-up as per the procedures.

Conditions
Osteosarcoma
Being tested
HS-20093, Gemcitabine combined with docetaxel
Keywords
phase 3, osteosarcoma, HS-20093
Medical subject headings
Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-20093Drug

    Study participants in the experimental group shall continue to receive HS-20093 by intravenous infusion at a dose of 12.0 mg/kg, once every 3 weeks (Q3W) with a 21-day treatment cycle. Treatment shall continue until objective disease progression (excluding cases of treatment beyond PD or crossover treatment) or until other criteria for termination of study treatment specified in the protocol are met.

  • Gemcitabine combined with docetaxelDrug

    Study participants in the control arm will receive gemcitabine in combination with docetaxel. Gemcitabine (1000 mg/m2) will be administered intravenously over approximately 30 minutes on Days 1 and 8 of each 21-day treatment cycle, followed by docetaxel (75 mg/m2) on Day 8, intravenously over approximately 1 hour until objective disease progression or other criteria for treatment discontinuation are met.

Study groups in NCT06935409
Study groupRoleWhat they receive
HS-20093ExperimentalStudy participants in the experimental group shall continue to receive HS-20093 by intravenous infusion at a dose of 12.0 mg/kg, once every 3 weeks (Q3W) with a 21-day treatment cycle. Treatment shall continue until objective disease progression (excluding cases of treatment beyond PD or crossover treatment) or until other criteria for termination of study treatment specified in the protocol are met.
Receives: Drug: HS-20093
Gemcitabine combined with docetaxelActive comparatorStudy participants in the control arm will receive gemcitabine in combination with docetaxel. Gemcitabine (1000 mg/m2) will be administered intravenously over approximately 30 minutes on Days 1 and 8 of each 21-day treatment cycle, followed by docetaxel (75 mg/m2) on Day 8, intravenously over approximately 1 hour until objective disease progression or other criteria for treatment discontinuation are met.
Receives: Drug: Gemcitabine combined with docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS assessed by IRC as per RECIST 1.1 criteria

    PFS is defined as the time interval from the randomization to disease progression as per ICR assessment or death due to any cause.

    Measured: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years.

Secondary outcomes (8)

  1. ORR assessed by IRC as per RECIST 1.1 criteria

    Confirmed ORR is defined as the sum of the complete response (CR) rate and partial response (PR) rate as per ICR per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

    Measured: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

  2. DCR assessed by IRC as per RECIST 1.1 criteria

    Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) per ICR per RECIST v1.1

    Measured: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

  3. DoR assessed by IRC as per RECIST 1.1 criteria

    Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first documentation of progressive disease (PD) or death

    Measured: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

  4. ORR assessed by the investigator as per RECIST 1.1 criteria

    Confirmed ORR is defined as the sum of the complete response (CR) rate and partial response (PR) rate as per investigator per RECIST v1.1

    Measured: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

  5. DCR assessed by the investigator as per RECIST 1.1 criteria

    Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) per investigator assessment per RECIST v1.1

    Measured: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

  6. DoR assessed by the investigator as per RECIST 1.1 criteria

    Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first documentation of progressive disease (PD) or death

    Measured: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

  7. PFS assessed by the investigator as per RECIST 1.1 criteria

    PFS is defined as the time interval from the randomization to disease progression as per investigator assessment or death due to any cause

    Measured: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

  8. OS

    Overall survival (OS) is defined as the time interval from randomization to death due to any cause

    Measured: From the date of randomization to the date of death due to any cause; Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2025
  2. Study start25 Apr 2025
  3. Primary completion17 Jun 2026
  4. Study completion7 Sep 2026

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06935409
Sponsor's protocol ID
HS-20093-304
Status last verified
Oct 2026
First submitted
17 Apr 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HS-20093 and Gemcitabine combined with docetaxel in people with Osteosarcoma, run by Hansoh BioMedical R&D Company at 2 sites in China.

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 8 inclusion and 26 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

PFS assessed by IRC as per RECIST 1.1 criteria (time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06935409.

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 19 Oct 2026.

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