CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 177 target
Drug / intervention
HS-20089 (Phase Ia：Dose escalation ) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05263479
NCT05263479Phase 1RecruitingUpdate OverdueUpdated 26mo ago · Completion was 17mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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

Shanghai Hansoh Biomedical Co., Ltd·interventional·Posted Mar 2, 2022·Updated Apr 3, 2024

In Brief

A Phase 1 clinical trial evaluating HS-20089 (Phase Ia：Dose escalation ) and HS-20089 (Phase Ib: Dose expansion) for Advanced Solid Tumor. Currently recruiting, targeting 177 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor
CountriesChina
Collaborators--

Timeline

Phase 1Recruiting
202220232024202520262027
First PostedMar 2, 2022
Enrollment StartJan 5, 2022
Primary CompletionDec 31, 2024
Study CompletionDec 31, 2026
TodayJul 1, 2026
Enrollment to primary: 3.0 yearsPosted 4.3 years ago

Interventions

HS-20089 (Phase Ia：Dose escalation )drug

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)drug

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.