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A Study of HS-20089 in Patients With Advanced Solid Tumors
Sponsor: Shanghai Hansoh Biomedical Co., Ltd
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
Conditions
Interventions
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.
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