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UnknownNCT05114759

A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

A Phase I, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
132 (estimated)
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in patients with advanced solid tumors.

Conditions

Interventions

TypeNameDescription
DRUGSHR-A2009In dose Escalation: SHR-A2009 will be administered intravenously. Six dose levels are preset. In dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.

Timeline

Start date
2022-01-04
Primary completion
2023-12-30
Completion
2024-12-30
First posted
2021-11-10
Last updated
2022-10-12

Locations

16 sites across 3 countries: China, Japan, South Korea

Source: ClinicalTrials.gov record NCT05114759. Inclusion in this directory is not an endorsement.

A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors (NCT05114759) · Clinical Trials Directory