A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SHR-3821 injection

• Registration Number: NCT06618651
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-26
• Study First Posted: 2024-10-01
• Study Start: 2024-11-13
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

1. Voluntary participation and written informed consent.
2. 18-75 years older, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
4. With a life expectancy ≥ 3 months.
5. Pathologically diagnosed advanced solid tumor.
6. Be able to provide fresh or archived tumour tissue.
7. At least one measurable lesion according to RECIST v1.1.
8. Adequate bone marrow reserve and organ function.
9. Contraception is required during the trial.

Exclusion Criteria

1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
2. Uncontrollable tumor-related pain.
3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
4. Received systemic antitumor therapy before the first dose.
5. Treated with similar target therapy as SHR-3821 before the first dose.
6. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
7. Unresolved CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy.
8. Current or History of ILD.
9. Active severe digestive disease.
10. Previous or co-existing malignancies.
11. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-3821.
12. Active hepatitis B or active hepatitis C.
13. Other inappropriate situation considered by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-3821 injection	SHR-3821 injection	-

Primary Outcome Measures

Name	Time	Method
DLT	3 weeks
AE	Screening up to study completion, an average of 1 year
MTD	3 weeks
RP2D	Screening up to study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

West China Hospital of Sichuan Hospital; 🇨🇳 Chengdu, Sichuan, China