RecruitingPhase 2NCT06001255

ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) and Advanced Solid Tumors

ARTEMIS-003: A Phase 2, Open-label, Multi-center Study to Evaluate Efficacy, Safety, and Pharmacokinetics, of Intravenous Administration of HS-20093 in Patients With Metastasis Castration Resistant Prostate Cancer and Advanced Solid Tumors Who Have Progressed Following at Least One Prior Therapy


Sponsor

Hansoh BioMedical R&D Company

Enrollment

120 participants

Start Date

Jan 18, 2024

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. The objectives of this study are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in Chinese patients with metastasis Castration Resistant Prostate Cancer. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) of HS-20093 as a monotherapy in subjects with metastasis castration resistant prostate cancers (mCRPC) and other solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called ARTEMIS-003) tests a new drug called HS-20093 in patients with advanced solid tumors — with a special focus on men with metastatic prostate cancer that is no longer responding to hormone treatment (called castration-resistant prostate cancer). **You may be eligible if...** - You are 18 years or older - You have been diagnosed with locally advanced or metastatic solid tumor cancer confirmed by biopsy - Standard treatments are no longer working, are unavailable, or you cannot tolerate them - You have at least one measurable tumor on imaging - Your overall health is good (ECOG performance status 0 or 1) and life expectancy is at least 12 weeks - You are willing to provide a tumor tissue sample **You may NOT be eligible if...** - Your cancer is responding to a current treatment - You have no measurable disease on imaging - You have significant organ dysfunction (heart, liver, kidneys) - You are 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

Intravenous (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(15)

Peking University Cancer Hospital

Beijing, China

Hunan Cancer Hospital

Changsha, China

Xiangya Hospital Central South University

Changsha, China

West China hospital, sichuan university

Chengdu, China

The First Affiliate Hospital of GUANGZHOU Medical University

Guangzhou, China

Yunnan Cancer Hospital

Kunming, China

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, China

Guangxi Medical University Cancer Hospital

Nanning, China

Fudan University Cancer Hospital

Shanghai, China

Liaoning Tumor Hospital

Shengyang, China

Shengjing Hospital of China Medical University

Shengyang, China

The First Hospital of China Medical University

Shengyang, China

Hubei Cancer Hospital

Wuhan, China

Tongji Hospital

Wuhan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT06001255