ARTEMIS-006: HS-20093 in Patients With Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Phase 2

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma

• Registration Number: NCT06007729
• Lead Sponsor: Hansoh BioMedical R&D Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-8-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs);Observed maximum plasma concentration (Cmax) of HS-20093;Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose in participants with advanced solid tumor;Terminal half-life (T1/2) of HS-20093 following IV dose in participants with advanced solid tumor;Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093;Percentage of participants with antibodies to HS-20093 in serum;ORR determined by Independent review committee (IRC) according to RECIST 1.1;Duration of response (DoR) determined by investigators and IRC according to RECIST 1.1;Disease control rate (DCR) determined by investigators and IRC according to RECIST 1.1;Progression-free survival (PFS) determined by investigators and IRC according to RECIST 1.1;Overall survival (OS)