A Phase 1 Dose Escalation and Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumors
Phase 1
Terminated
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT04842630
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SHR-1916 SHR-1916 -
- Primary Outcome Measures
Name Time Method Dose Limited Toxicity (DLT) 21 Days (first cycle) Recommended dose for phase II (RP2D) Up to 8 months Maximum tolerable dose (MTD) 21 Days (first cycle)
- Secondary Outcome Measures
Name Time Method 12-month-survival Rate up to 2 years Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-1916 30 days after last dose Minimum observed plasma concentration (Cmin) of SHR-1916 30 days after last dose Time of maximum observed plasma concentration (Tmax) of SHR-1916 30 days after last dose PFS（Progression-Free-Survival） up to 2 years AEs （Adverse Events） 30 days after last dose Percentage of NK cell and CD8+ T cell by flow cytometry 30 days after last dose Absolute count values of NK cell and CD8+ T cell by flow cytometry 30 days after last dose ORR（Objective Response Rate） at the time point of every 9 weeks Immunogenicity analysis to assess anti-drug antibodies (ADA) to SHR-1916 in human serum 30 days after last dose DoR（Duration of Response） up to 2 years Maximum observed plasma concentration (Cmax) of SHR-1916 30 days after last dose Peripheral plasma concentration of sCD25 30 days after last dose DCR（Disease Control Rate） at the time point of every 9 weeks
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China