Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3821 Injection in Subjects With Advanced Solid Tumors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country162 target enrollmentNovember 13, 2024

ConditionsAdvanced Solid Tumors

InterventionsSHR-3821 injection

DrugsSHR-3821 injection

Overview

Phase: Phase 1
Intervention: SHR-3821 injection
Conditions: Advanced Solid Tumors
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 162
Locations: 1
Primary Endpoint: DLT
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

November 13, 2024

End Date

January 1, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary participation and written informed consent.
•18-75 years older, no gender limitation.
•Eastern Cooperative Oncology Group (ECOG) score: 0-
•With a life expectancy ≥ 3 months.
•Pathologically diagnosed advanced solid tumor.
•Be able to provide fresh or archived tumour tissue.
•At least one measurable lesion according to RECIST v1.
•Adequate bone marrow reserve and organ function.
•Contraception is required during the trial.

Exclusion Criteria

•Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
•Uncontrollable tumor-related pain.
•Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
•Received systemic antitumor therapy before the first dose.
•Treated with similar target therapy as SHR-3821 before the first dose.
•Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
•Unresolved CTCAE 5.0\>=grade 2 toxicities from previous anticancer therapy.
•Current or History of ILD.
•Active severe digestive disease.
•Previous or co-existing malignancies.

Arms & Interventions

SHR-3821 injection

Intervention: SHR-3821 injection

Outcomes

Primary Outcomes

DLT

Time Frame: 3 weeks

Time Frame: Screening up to study completion, an average of 1 year

MTD

Time Frame: 3 weeks

RP2D

Time Frame: Screening up to study completion, an average of 1 year

Secondary Outcomes

PK parameters of SHR-3821 after single and continuous administration: AUC0-t(Screening up to study completion, an average of 1 year)
Drug Resistant Antibody (ADA) to SHR-3821(Screening up to study completion, an average of 1 year)
Blood concentration of SHR-3821 after single and continuous administration(Screening up to study completion, an average of 1 year)
PK parameters of SHR-3821 after single and continuous administration: Tmax(Screening up to study completion, an average of 1 year)
PK parameters of SHR-3821 after single and continuous administration: Cmax(Screening up to study completion, an average of 1 year)
Objective response rate (ORR)(Screening up to study completion, an average of 1 year)
Disease control rate (DCR)(Screening up to study completion, an average of 1 year)
Progression-free survival (PFS)(Screening up to study completion, an average of 1 year)
Overall survival (OS)(Screening up to study completion, an average of 1 year)