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

An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies

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.

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. Subjects with interstitial pneumonia or interstitial lung disease, with a history of interstitial pneumonia or interstitial lung disease limiting self care ADL or with life-threatening respiratory compromise, with a history of pulmonary fibrosis, lasting pneumonia, drug- or radiation-induced pneumonia, and congenital pneumonia that may otherwise interfere with the judgement of immune-related pulmonary toxicity, or with any evidence of active pneumonia as shown on chest CT scans;
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.