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

• Status: Not yet recruiting
• Trial end date: 2025-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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.