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

SHR-1916-I-101

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.

2021-04-08

2022-11-01

2022-11-01

Terminated

Early phase I

11

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

2024-02-09