A Study of SHR-4375 in Subjects With Solid Tumors

NCT ID: NCT06764628

Last Updated: 2025-01-22

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/PHASE2

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-09

Study Completion Date

2027-05-31

Brief Summary

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

This is an open-label, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with solid tumors.

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 Tumors

Study Design

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

Allocation Method

NA

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.

Treatment group

Group Type EXPERIMENTAL

SHR-4375

Intervention Type DRUG

SHR-4375 injection

Interventions

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

SHR-4375

SHR-4375 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. The subjects voluntarily joined the study and signed the ICF.
2. Measurable disease, as defined by RECIST v1.1.
3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 12 weeks.
5. Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy.

Exclusion Criteria

1. Symptomatic, untreated or active central nervous system metastases.
2. With any active autoimmune disease or history of autoimmune disease.
3. Patients with active hepatitis B or hepatitis C.
4. Severe infections prior to initiation of study treatment.
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.

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 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.

Yuanchao Wang

Role: CONTACT

0518-82342973

Facility Contacts

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

Xianjun Yu

Role: primary

021-64175590

Xiaohua Wu

Role: backup

021-64175590 ext. 81000

Other Identifiers

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

SHR-4375-101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

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