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

NCT06618651 | Recruiting Phase 1

• 1 other identifier: SHR-3821-101
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• 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

• 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

Study Arms (1)

SHR-3821 injection

EXPERIMENTAL

Drug: SHR-3821 injection

Interventions

SHR-3821 injection DRUG

SHR-3821 injection

SHR-3821 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and written informed consent.
• years older, no gender limitation.
• Eastern Cooperative Oncology Group (ECOG) score: 0-1.
• 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 v1.1.
• Adequate bone marrow reserve and organ function.
• Contraception is required during the trial.

You may not qualify if:

• 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.
• History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-3821.
• Active hepatitis B or active hepatitis C.
• Other inappropriate situation considered by the investigator.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

Central Study Contacts

Bin bai

CONTACT

+86 15618539080; bin.bai@hengrui.com

Hao Shen

CONTACT

+86 021-61053363; hao.shen@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: November 13, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)