Unspecified Adult Solid Tumor, Protocol Specific
Conditions
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.
Interventions
DRUGSHR-1916
All participants receive SHR-1906 alone
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limited Toxicity (DLT) | 21 Days (first cycle) |
| Maximum tolerable dose (MTD) | 21 Days (first cycle) |
| Recommended dose for phase II (RP2D) | Up to 8 months |
Secondary
| Measure | Time frame |
|---|---|
| AEs （Adverse Events） | 30 days after last dose |
| Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-1916 | 30 days after last dose |
| Maximum observed plasma concentration (Cmax) 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 |
| DoR（Duration of Response） | up to 2 years |
| Absolute count values of NK cell and CD8+ T cell by flow cytometry | 30 days after last dose |
| Peripheral plasma concentration of sCD25 | 30 days after last dose |
| Immunogenicity analysis to assess anti-drug antibodies (ADA) to SHR-1916 in human serum | 30 days after last dose |
| ORR（Objective Response Rate） | at the time point of every 9 weeks |
| DCR（Disease Control Rate） | at the time point of every 9 weeks |
| Percentage of NK cell and CD8+ T cell by flow cytometry | 30 days after last dose |
| PFS（Progression-Free-Survival） | up to 2 years |
| 12-month-survival Rate | up to 2 years |
Countries
China
Outcome results
None listed