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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SHR-3792 Injection

• Registration Number: NCT06907628
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Status Verified: 2025-04
• Study Start: 2025-04-02
• Study First Posted: 2025-04-02
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-3792 Injection Group	SHR-3792 Injection	-

Primary Outcome Measures

Name	Time	Method
Recommended phase Ⅱ dose (RP2D)	From the first dose of study medication up to 21 days.
Incidence of dose limited toxicity (DLT)	From the first dose of study medication up to 21 days.
Adverse events (AEs)	Up to 24 weeks.
Serious adverse events (SAEs)	Up to 24 weeks.
Maximum tolerated dose (MTD)	From the first dose of study medication up to 21 days.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to 6 months.

Trial Locations

Locations (1)

Shandong First Medical University Affiliated Cancer Hospital; 🇨🇳 Jinan, Shandong, China