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

NCT05276609 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2023-02-15

No results posted yet for this 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. 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.

Conditions

  • Advanced Solid Tumor

Interventions

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.

Sponsors & Collaborators

  • Shanghai Hansoh Biomedical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-28
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05276609 on ClinicalTrials.gov