MedTrace Logo

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

NCT05263479 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2024-04-03

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

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.

Sponsors & Collaborators

  • Shanghai Hansoh Biomedical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jiong Wu, PhD · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-05
Primary Completion
2024-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT05263479 on ClinicalTrials.gov