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

NCT06907628 | Recruiting Phase 1

• 1 other identifier: SHR-3792-101
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Maximum tolerated dose (MTD)

  From the first dose of study medication up to 21 days.

• 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.

Secondary Outcomes (1)

• Objective response rate (ORR)

  Up to 6 months.

Study Arms (1)

SHR-3792 Injection Group

EXPERIMENTAL

Drug: SHR-3792 Injection

Interventions

SHR-3792 Injection DRUG

SHR-3792 injection.

SHR-3792 Injection Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shandong First Medical University Affiliated Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Central Study Contacts

Fangfang Peng

CONTACT

+86-0518-81220121; fangfang.peng.fp5@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

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

CN (1)