Status:
TERMINATED
A Phase 1 Dose Escalation and Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumors
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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;
- History of immunodeficiency (including HIV infection) or organ transplantation;
- Known active hepatitis B or C infection;
- Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04842630
Start Date
April 8 2021
End Date
November 1 2022
Last Update
February 9 2024
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142