Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06618651

Recruiting

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

Interventional

Phase 1

West China Hospital of Sichuan Hospital

Sponsor: Suncadia Biopharmaceuticals

Last Updated: November 17, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Treatment Category

Other Drugs

Required Mutations

None

Trial Started

November 13, 2024

Last Updated by Sponsor

November 17, 2025

Estimated Completion

January 1, 2026

Contact Study

Name:Bin bai

Email:bin.bai@hengrui.com

Phone:+86 15618539080

Name:Hao Shen

Email:hao.shen@hengrui.com

Phone:+86 021-61053363

Eligibility

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.

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll162

Arms & Interventions

Arms

Interventions

Type: Experimental

Description:

Interventions:

SHR-3821 injection

Outcome Measures

Primary Outcome Measures

DLT3 weeks

AEScreening up to study completion, an average of 1 year

MTD3 weeks

RP2DScreening up to study completion, an average of 1 year

Secondary Outcome Measures

Blood concentration of SHR-3821 after single and continuous administrationScreening up to study completion, an average of 1 year

PK parameters of SHR-3821 after single and continuous administration: TmaxScreening up to study completion, an average of 1 year

PK parameters of SHR-3821 after single and continuous administration: CmaxScreening up to study completion, an average of 1 year

PK parameters of SHR-3821 after single and continuous administration: AUC0-tScreening up to study completion, an average of 1 year

Drug Resistant Antibody (ADA) to SHR-3821Screening 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

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Trial Sites

This study has 1 trial site

West China Hospital of Sichuan Hospital

Chengdu, Sichuan, CN

Name:Jiankun Hu

Recruiting

Chengdu, Sichuan, 610000 CN

West China Hospital of Sichuan Hospital

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