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HS-20093 treatment for head and neck cancer and other solid tumors

ARTEMIS-006: A Phase 2 Study to Evaluate Efficacy and Safety of Intravenous Administration of HS-20093 in Patients With Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Phase 2 Interventional Hansoh BioMedical R&D Company · NCT06007729

This study is testing a new treatment called HS-20093 to see if it can help people with advanced head and neck cancer and other solid tumors who haven't had success with standard therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment170 (estimated)
Ages18 Years and up
SexAll
SponsorHansoh BioMedical R&D Company Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations25 sites (Hefei, Anhui and 24 other locations)
Trial IDNCT06007729 on ClinicalTrials.gov

What this trial studies

This phase 2, open-label, multi-center study evaluates the efficacy, safety, pharmacokinetics, and immunogenicity of HS-20093, a fully humanized antibody-drug conjugate targeting B7-H3, in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) and other advanced solid tumors. The study consists of two parts: Phase 2a includes patients who have progressed on or are intolerant to standard therapies, while Phase 2b focuses specifically on HNSCC patients. All participants will receive 10.0 mg/kg of HS-20093 and will be monitored for adverse events and clinical benefits during and after treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with recurrent or metastatic head and neck squamous cell carcinoma or other solid tumors who have progressed on or are intolerant to standard therapies.

Not a fit: Patients who have previously received B7-H3 targeted therapy or those with certain recent treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced head and neck cancer and other solid tumors who have limited treatment options.

How similar studies have performed: While this approach is novel in targeting B7-H3 with HS-20093, similar studies targeting other pathways have shown promise in treating solid tumors.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 1\. At least age of 18 years at screening. 2. Patients，who have progressed on or intolerant to standard therapie，with histologically confirmed recurrent/metastatic HNSCC or other solid tumor.

  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\. Female 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 small molecule targeted therapy within 14 days prior to the first scheduled dose of HS-20093
  3. Prior treatment with macromolecule anti-tumor therapy or other anticancer drugs 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 stable hypothyroidism treated with hormone replacement therapy, 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

Where this trial is running

Hefei, Anhui and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Head and Neck Squamous Cell Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.