RecruitingPhase 2NCT06007729

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


Sponsor

Hansoh BioMedical R&D Company

Enrollment

170 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HS-20093 (an antibody-drug conjugate targeting a protein called B7-H3) in patients with head and neck squamous cell carcinoma or other solid tumors that have stopped responding to standard treatments. **You may be eligible if:** - You are 18 or older - You have confirmed recurrent or metastatic head and neck cancer or another solid tumor - Your cancer has progressed despite standard therapies - You have at least one measurable tumor on imaging - You are in good general health (ECOG 0–1) **You may NOT be eligible if:** - You have previously received B7-H3-targeted therapy - You had chemotherapy or targeted therapy within the past 2 weeks - You have brain metastases or spinal cord compression - You have fluid buildup around the lungs or heart requiring treatment - You recently had major surgery or take certain heart medications - You are pregnant or could become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHS-20093

Participants in all subjucts will receive HS-20093 at 10mg/kg


Locations(25)

Anhui Cancer Hospital

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yai-Sen Memorial Hospital Sun Yai-Sen University

Guangzhou, Guangdong, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

The Fifth Affiliated Hospital Sun Yat-Sen University

Zhuhai, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Second XIANGYA Hospital Of Central South University

Changsha, Hunan, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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

Shanghai, Shanghai Municipality, China

The first Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Cancer hospital of Xinjiang medical University

Xinjiang, Xinjiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06007729


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