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RECRUITING
NCT05263479
PHASE1

A Study of HS-20089 in Patients With Advanced Solid Tumors

Sponsor: Shanghai Hansoh Biomedical Co., Ltd

View on ClinicalTrials.gov

Summary

HS-20089 is a novel DAR-6 antibody-drug conjugate (ADC) targeting B7-H4. In preclinical studies, it inhibited tumor cell growth expressing B7-H4 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20089 in Patients With Advanced Solid Tumors.

Official title: A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20089 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

177

Start Date

2022-01-05

Completion Date

2026-12-31

Last Updated

2024-04-03

Healthy Volunteers

No

Interventions

DRUG

HS-20089 (Phase Ia:Dose escalation )

Participants will receive HS-20089 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

DRUG

HS-20089 (Phase Ib: Dose expansion)

IV administration of HS-20089 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Locations (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China