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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

ARTEMIS-002: HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas

ARTEMIS-002: A Phase 2, Multicenter, Open-label Study of Intravenous Administration of HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas

ARTEMIS-002: HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas (NCT05830123) is a Phase 2 interventional studying Osteosarcoma and Sarcoma, sponsored by Hansoh BioMedical R&D Company. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with relapsed or refractory osteosarcoma and other sarcomas.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Osteosarcoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 170 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Osteosarcoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. At least age of 18 years at screening; 2. Patients with diagnosed by tissue sample (biopsy-confirmed) relapsed or refractory osteosarcoma or other sarcomas who have progressed upon first-line systemic treatment. 3. At least one measurable lesion according to RECIST 1.1. 4. Agree to provide fresh or archival tumor tissue and peripheral blood samples. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1 6. Life expectancy \>= 12 weeks 7. Men or women should be using adequate contraceptive measures throughout the study; 8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential 9. Signed and dated willing to sign a consent form Form Who Should NOT Join This Trial: 1. Treatment with any of the following: 1. Previous or current treatment with B7-H3 targeted therapy 2. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093 3. Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093 4. Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093 5. Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion. 6. Major surgery within 4 weeks of the first dose of HS-20093. 7. Spinal cord compression or brain metastases. 8. Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study. 9. Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. At least age of 18 years at screening; 2. Patients with histologically confirmed relapsed or refractory osteosarcoma or other sarcomas who have progressed upon first-line systemic treatment. 3. At least one measurable lesion according to RECIST 1.1. 4. Agree to provide fresh or archival tumor tissue and peripheral blood samples. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1 6. Life expectancy \>= 12 weeks 7. Men or women should be using adequate contraceptive measures throughout the study; 8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential 9. Signed and dated Informed Consent Form Exclusion Criteria: 1. Treatment with any of the following: 1. Previous or current treatment with B7-H3 targeted therapy 2. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093 3. Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093 4. Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093 5. Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion. 6. Major surgery within 4 weeks of the first dose of HS-20093. 7. Spinal cord compression or brain metastases. 8. Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study. 9. Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study. 2. Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity. 3. History of other primary malignancies. 4. Inadequate bone marrow reserve or organ dysfunction 5. Evidence of cardiovascular risk. 6. Severe, uncontrolled or active cardiovascular diseases. 7. Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug, or the glycosylated hemoglobin value ≥ 7.5% in the screening period. 8. Severe or poorly controlled hypertension. 9. Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 months prior to the first dose of HS-20093 10. Serious arteriovenous thrombosis events occurred within 3 months before the first dose. 11. Severe infections occurred within 4 weeks before the first dose. 12. Patients who have received continuous steroid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation 13. The presence of active infectious diseases has been known before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc. 14. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis. 15. Other moderate or severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity or may seriously affect respiratory function. 16. Previous history of serious neurological or mental disorders, including epilepsy, dementia or severe depression and any other status that may interfere in assessment. 17. Women who are breastfeeding or pregnant or planned to be pregnant during the study period. 18. Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093 19. History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins. 20. Hypersensitivity to any ingredient of HS-20093. 21. Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator 22. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments

Treatments Being Tested

DRUG

HS-20093

IV administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Locations (11)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University People's Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Chinese PLA General Hospital of Eastern Theater Command
Nanjing, China
Shanghai 6th People's Hospital
Shanghai, China
Shanghai General Hospital
Shanghai, China
Tianjin Cancer Hospital
Tianjin, China
Henan Cancer Hospital
Zhengzhou, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05830123), the sponsor (Hansoh BioMedical R&D Company), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05830123 clinical trial studying?

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with relapsed or refractory osteosarcoma and other sarcomas. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05830123?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05830123?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05830123. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05830123. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.