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

Last updated: August 19, 2024
Sponsor: Hansoh BioMedical R&D Company
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Squamous Cell Carcinoma

Lung Cancer

Treatment

HS-20093

Clinical Study ID

NCT06007729
HS-20093-205
  • Ages > 18
  • All Genders

Study Summary

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 head and neck squamous cell carcinoma and other solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. At least one measurable lesion according to RECIST 1.1. 4. Agree to providefresh or archival tumor tissue and peripheral blood samples.

  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1. 6. Lifeexpectancy >= 12 weeks. 7. Men or women should be using adequate contraceptivemeasures throughout the study.

  4. Female subjects must not be pregnant at screening or have evidence ofnon-childbearing potential.

  5. Signed and dated Informed Consent Form.

Exclusion

Exclusion Criteria:

  1. Treatment with any of the following:

  2. Previous or current treatment with B7-H3 targeted therapy

  3. Any cytotoxic chemotherapy, investigational agents and small molecule targetedtherapy within 14 days prior to the first scheduled dose of HS-20093

  4. Prior treatment with macromolecule anti-tumor therapy or other anticancer drugswithin 28 days prior to the first scheduled dose of HS-20093

  5. Radiotherapy with a limited field of radiation for palliation within 2 weeks,or patients received more than 30% of the bone marrow irradiation, orlarge-scale radiotherapy within 4 weeks prior to the first scheduled dose ofHS-20093

  6. Pleural or peritoneal effusion requiring clinical intervention. Pericardialeffusion

  7. Major surgery within 4 weeks of the first dose of HS-20093

  8. Spinal cord compression or brain metastases.

  9. Treatment with drugs that are predominantly CYP3A4 strong inhibitors orinducers or sensitive substrates of CYP3A4 with a narrow therapeutic rangewithin 7 days of the first dose of study drug; or requiring treatment withthese drugs during the study.

  10. Currently receiving drugs known to prolong QT interval or may cause torsade depointe; or requiring treatment with these drugs during the study.

  11. Any unresolved toxicities from prior therapy greater than Grade 2 according toCommon Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exceptionof stable hypothyroidism treated with hormone replacement therapy, alopecia orneurotoxicity.

  12. History of other primary malignancies. 4. Inadequate bone marrow reserve ororgan dysfunction 5. Evidence of cardiovascular risk. 6. Severe, uncontrolledor active cardiovascular diseases. 7. Diabetes ketoacidosis or hyperglycemiahypertonic occurring within 6 months before the first dose of the study drug,or the glycosylated hemoglobin value ≥ 7.5% in the screening period.

  13. Severe or poorly controlled hypertension. 9. Bleeding symptoms with apparentclinical significance or obvious bleeding tendency within 1 months prior to thefirst dose of HS-20093 10. Serious arteriovenous thrombosis events occurredwithin 3 months before the first dose.

  14. Severe infections occurred within 4 weeks before the first dose. 12. Patientswho have received continuous steroid treatment for more than 30 days within 30days before the first dose, or need long-term (≥ 30 days) steroid treatment, orwho have other acquired and congenital immunodeficiency diseases, or have ahistory of organ transplantation 13. The presence of active infectious diseaseshas been known before the first dose such as hepatitis B, hepatitis C,tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.

  15. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or moresevere cirrhosis.

  16. Other moderate or severe lung diseases that may interfere with the detection ortreatment of drug-related pulmonary toxicity or may seriously affectrespiratory function.

  17. Previous history of serious neurological or mental disorders, includingepilepsy, dementia or severe depression and any other status that may interferein assessment.

  18. Women who are breastfeeding or pregnant or planned to be pregnant during thestudy period.

  19. Vaccination or hypersensitivity of any level within 4 weeks prior to the firstdose of HS-20093 19. History of severe hypersensitivity reaction, severeinfusion reaction or allergy to recombinant human or mouse derived proteins.

  20. Hypersensitivity to any ingredient of HS-20093. 21. Unlikely to comply withstudy procedures, restrictions, and requirements in the opinion of theinvestigator 22. Any disease or condition that, in the opinion of theinvestigator, would compromise subject safety or interfere with studyassessments

Study Design

Total Participants: 170
Treatment Group(s): 1
Primary Treatment: HS-20093
Phase: 2
Study Start date:
December 18, 2023
Estimated Completion Date:
December 12, 2027

Study Description

This is a phase 2, open-label, multi-center study consisting of two parts: Phase 2a and 2b.

Phase 2a: The study will be conducted in the following two cohorts: Cohort 1: Patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed on or intolerant to standard therapies. Cohort 2: Other patients with advanced solid tumors if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. All subjects will receive 10.0 mg/kg of HS-20093.

Phase 2b: The study will be conducted in patients with recurrent/metastatic HNSCC who have progressed on or intolerant to standard therapies. Subjects will receive 10.0 mg/kg of HS-20093.

All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of HS-20093. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.

Connect with a study center

  • Anhui Cancer Hospital

    Hefei, Anhui
    China

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Beijing Tongren Hospital, CMU

    Beijing, Beijing
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian
    China

    Active - Recruiting

  • Sun Yai-Sen Memorial Hospital Sun Yai-Sen University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai, Guangdong
    China

    Active - Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • The Second XIANGYA Hospital Of Central South University

    Changsha, Hunan
    China

    Active - Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning
    China

    Site Not Available

  • Liaoning Cancer Hospital

    Shenyang, Liaoning
    China

    Active - Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai 200120
    China

    Active - Recruiting

  • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, Shanghai
    China

    Active - Recruiting

  • The first Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi
    China

    Active - Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Active - Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Cancer hospital of Xinjiang medical University

    Xinjiang, Xinjiang
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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