A Phase 1 Dose Escalation and Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2023-10-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a first in human, open-label, dose escalation and expansion Phase 1 study of SHR-1916 in adult patients with locally advanced or metastatic solid tumors.

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

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document；

2. Aged between 18-75 years old;

3. Histologically or cytologically confirmed advanced or metastatic malignant tumor;

4. Presence of at least of one measurable lesion in agreement to RECIST criteria;

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;

6. Life expectancy >12 weeks;

7. Adequate organ performance based on laboratory blood tests;

8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

1. Patients who have received cytokines (IL-2, IFN-α)as anti-tumor therapy within 6 months before the first dose;

2. Previous systemic therapy within 28 days before the first dose;

3. Previous therapeutic surgery within 28 days, and diagnostic surgery within 14 days prior to the first dose;

4. Received live attenuated vaccine within 28 days before the first dose, or expected to receive live attenuated vaccine during the study treatment period;

5. Patients who received systemic immunosuppressive therapy within 14 days before the first dose;

6. Patients with known or suspected brain metastasis；

7. Patients with interstitial pneumonia or interstitial lung disease, or history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other pneumonia history that may interfere with the judgment of immune related pulmonary toxicity, or chest CT scan found any evidence of active pneumonia;

8. Patients with history of autoimmune diseases;

9. History of immunodeficiency (including HIV infection) or organ transplantation;

10. Known active hepatitis B or C infection;

11. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.