Advanced Solid Tumors
Conditions
Brief summary
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.
Interventions
Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SHR-7787 injection monotherapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. Patients with unresectable recurrent or metastatic solid tumors; 3. There is at least one lesion could be measured; 4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 5. Adequate organ functions as defined; 6. Life expectancy ≥3 months.
Exclusion criteria
1. Patients with known active central nervous system (CNS) metastases; 2. Subjects who had other malignancy in five years before the first dose; 3. Patients with tumor-related pain that cannot be controlled as determined; 4. Patients with serious cardiovascular and cerebrovascular diseases; 5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion; 6. Patients with Severe infections; 7. History of immunodeficiency; 8. History of autoimmune diseases; 9. Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy 10. Active infection; 11. Pregnant or nursing women; 12. Known history of serious allergic reactions to the investigational product or its main ingredients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose | first dose of study medication up to 21 days | The Maximum tolerated dose of SHR-7787 injection monotherapy |
| Recommended phase II dose | first dose of study medication up to 21 days | The Recommended phase II dose of SHR-7787 injection monotherapy |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | from signature completion of ICF to 60 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks | Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Incidence of Dose Limited Toxicity (DLT) | from first dose to 4 weeks | Incidence of Dose Limited Toxicity (DLT) described in the protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADA | 0.5 hour before first dose through study completion, an average of 1 year | Anti-drug antibody, Immunogenicity of SHR-7787 in monotherapy |
| Tmax | predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose | PK parameters of single dose of SHR-7787 injection monotherapy |
| ORR | from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months | Objective Response Rate, Efficacy endpoints of SHR-7787 injection monotherapy in treatment of patients with advanced solid tumors |
| Cmax | predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose | PK parameters of single dose of SHR-7787 injection monotherapy |
| AUC0-t | predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose | PK parameters of single dose of SHR-7787 injection monotherapy |
| t1/2 | predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose | PK parameters of single dose of SHR-7787 injection monotherapy |
Countries
China
Contacts
Primary ContactKe Ma
Outcome results
None listed