NCT05276609

ARTEMIS-001: Phase 1 Study of the HS-20093 in Patients With Advanced Solid Tumors

ARTEMIS-001: A Phase 1, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Doses of Intravenous Administration of HS-20093 in Patients With Locally Advanced or Metastatic Solid Tumors Who Have Progressed Following Prior Therapy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: Shanghai Hansoh Biomedical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in Chinese advanced solid tumor patients. This is a phase 1, open-label, multi-center, dose-escalation and expansion study evaluating the safety, tolerability, pharmacokinetic (PK), and the therapeutic potential of HS-20093 as a monotherapy in subjects with advanced solid tumors.

Detailed description

This is an open-label, multi-center, dose-escalation and expansion, first-in-human phase 1 study in Chinese adult participants with locally advanced or metastatic solid tumors. This study will consist of two parts: A Part Ia dose escalation stage and a Part Ib dose expansion stage. The objectives of this study are to evaluate the safety, tolerability, PK and preliminary anti-tumor activity, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of HS-20093. Part Ia: Participants with advanced cancer are eligible for dose escalation study if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. The dose escalation will include an initial accelerated titration design followed by i3+3 design. Part Ib: Enrollment into dose expansion will begin after identification of the MTD or MAD in Phase Ia. The dose expansion study will be conducted in populations with the following indications: locally advanced or metastatic non- small cell lung cancer (NSCLC)，extensive stage small cell lung cancer (ES-SCLC) and other types of advanced solid tumor. All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HS-20093 (Phase Ia: Dose escalation)	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.
DRUG	HS-20093 (Phase Ib: Dose expansion)	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.

Timeline

• Start date: 2021-11-28
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-03-11
• Last updated: 2023-02-15

Locations

1 site across 1 country: China