A Trial of SHR-3792 Injection in Patients With Advanced Solid Tumors

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: SHR-3792 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06907628

SHR-3792-101

Details and patient eligibility

About

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-3792 injection monotherapy for patients with advanced solid tumors, and to explore the reasonable dosage of SHR-3792 injection monotherapy for patients with advanced solid tumors.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects with ability to understand and voluntarily agree to participate by giving written informed consent form for the study.
2. Patients with unresectable recurrent or metastatic solid tumors.
3. There is at least one lesion that could be measured.
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
5. Adequate organ functions as defined.
6. Life expectancy ≥ 3 months.

Exclusion criteria

1. Patients with known active central nervous system (CNS) metastases.
2. Subjects with other malignancy in five years before the first dose.
3. Patients with tumor-related pain that cannot be controlled as determined.
4. Patients with serious cardiovascular and cerebrovascular diseases.
5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
6. Patients with severe infections.
7. History of immunodeficiency.
8. History of autoimmune diseases.
9. Active infection.
10. Pregnant or nursing women.
11. Known history of serious allergic reactions to the investigational product or its main ingredients.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

SHR-3792 Injection Group

Experimental group

Treatment:

Drug: SHR-3792 Injection