A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor

NCT ID: NCT07275242

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-23

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low-Dose Group

Group Type EXPERIMENTAL

SHR-A1811 Subcutaneous Injection

Intervention Type DRUG

SHR-A1811 subcutaneous injection.

SHR-A1811 for Injection

Intervention Type DRUG

SHR-A1811 for injection.

Medium-Dose Group

Group Type EXPERIMENTAL

SHR-A1811 Subcutaneous Injection

Intervention Type DRUG

SHR-A1811 subcutaneous injection.

SHR-A1811 for Injection

Intervention Type DRUG

SHR-A1811 for injection.

High-Dose Group

Group Type EXPERIMENTAL

SHR-A1811 Subcutaneous Injection

Intervention Type DRUG

SHR-A1811 subcutaneous injection.

SHR-A1811 for Injection

Intervention Type DRUG

SHR-A1811 for injection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SHR-A1811 Subcutaneous Injection

SHR-A1811 subcutaneous injection.

Intervention Type DRUG

SHR-A1811 for Injection

SHR-A1811 for injection.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. ≥18 years of age;
2. Solid Tumor confirmed by histology or cytology;
3. ECOG score is 0 or 1;
4. An expected survival of ≥ 12 weeks;
5. At least one measurable lesion according to RECIST v1.1 criteria;
6. Have adequate renal and hepatic function;
7. Patients voluntarily joined the study and signed informed consent.

Exclusion Criteria

1. With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer;
2. Patients have major surgical procedures or radiotherapy / chemotherapy within 4 weeks before the first medication;
3. History of immunodeficiency;
4. Clinically significant cardiovascular diseases;
5. Known or suspected interstitial lung disease;
6. Known hereditary or acquired bleeding thrombotic tendency;
7. Active hepatitis and liver cirrhosis;
8. Known allergic history of the drug components of this protocol;
9. History of neurological or psychiatric disorders.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yue Zhang

Role: CONTACT

+86-0518-82342973

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Erwei Song

Role: primary

+86-020-81332507

Herui Yao

Role: backup

+86-020-81332507

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHR-A1811(sc)-101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of SHR-4375 in Subjects With Solid Tumors
NCT06764628 RECRUITING PHASE1/PHASE2
A Study of SHR-A1904 in Patients With Advanced Solid Cancer
NCT04877717 ACTIVE_NOT_RECRUITING PHASE1
A Trial of SHR-7367 in Subjects With Advanced Solid Tumors
NCT05740202 ACTIVE_NOT_RECRUITING PHASE1