A Trial of SHR-7367 in Subjects With Advanced Solid Tumors

NCT ID: NCT05740202

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2025-11-30

Brief Summary

This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-7367

Group Type: EXPERIMENTAL

SHR-7367

Intervention Type: DRUG

The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.

Interventions

SHR-7367

The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;

2. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;

3. Histopathologically or cytologically documented advanced or metastatic malignancies;

4. At least 1 measurable lesion conforming to RECIST 1.1 criteria;

5. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;

6. Female and male patients of reproductive potential must agree to use highly effective contraception.

Exclusion Criteria

1. Any immunostimulants administered within 4 weeks;

2. Systemic anti-tumor therapy within 4 weeks;

3. Any investigational cancer therapy administered within 4 weeks;

4. Surgical procedures requiring general anesthesia within 4 weeks;

5. History of autoimmune diseases;

6. History of immunodeficiency;

7. Severe infections within 2 weeks prior to the first study treatment;

8. Clinically significant cardiovascular condition;

9. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;

10. Known history of serious allergic reactions to the investigational product or its main ingredients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

SHR-7367-I-101

Identifier Type: -

Identifier Source: org_study_id