A Phase 1 Dose Escalation and Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Me… (NCT04842630) | Clinical Trial Compass
TerminatedPhase 1
A Phase 1 Dose Escalation and Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumors
Stopped: R\&d strategy adjustment
China11 participantsStarted 2021-04-08
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Ability to understand and the willingness to sign a written informed consent document；
✓. Aged between 18-75 years old;
✓. Histologically or cytologically confirmed advanced or metastatic malignant tumor;
✓. Presence of at least of one measurable lesion in agreement to RECIST criteria;
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
✓. Life expectancy \>12 weeks;
✓. Adequate organ performance based on laboratory blood tests;
✓. 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
✕. Patients who have received cytokines (IL-2, IFN-α)as anti-tumor therapy within 6 months before the first dose;
✕. Previous systemic therapy within 28 days before the first dose;
✕. Previous therapeutic surgery within 28 days, and diagnostic surgery within 14 days prior to the first dose;
✕. Received live attenuated vaccine within 28 days before the first dose, or expected to receive live attenuated vaccine during the study treatment period;
. Patients who received systemic immunosuppressive therapy within 14 days before the first dose;
✕. Patients with known or suspected brain metastasis；
✕. 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;
✕. Patients with history of autoimmune diseases;