Malignant Solid Tumors
Conditions
Brief summary
This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.
Interventions
DRUGSHR-4849 Injection
SHR-4849 Injection.
SHR-7787 Injection.
SHR-1316 Injection.
Etoposide Injection.
DRUGCarboplatin injection
Carboplatin Injection.
DRUGCisplatin injection
Cisplatin Injection.
DRUGBP102 Injection
BP102 Injection.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
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 voluntarily agrees to participate by giving written informed consent for the study; 2. Patients with histologically or cytologically confirmed unresectable solid tumors; 3. At least one measurable lesion was identified per RECIST 1.1; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 5. Adequate organ functions as defined per protocol; 6. Minimum life expectancy of 3 months.
Exclusion criteria
1. Patients with known active central nervous system (CNS) metastases; 2. History of other malignancy within the past 5 years, with exceptions defined in the protocol; 3. Patients with uncontrolled cancer pain; 4. Patients with serious cardiovascular and/or cerebrovascular diseases; 5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion; 6. Patients with Severe infections within 4 weeks prior to the first dose; 7. Active pulmonary tuberculosis infection; 8. History of immunodeficiency; 9. History of autoimmune diseases; 10. The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1; 11. Pregnant or nursing women, or planned to become pregnant during the study period; 12. Known allergic to any component of investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival (FPS) (stage II) | Expected to be two years after the start of the study. |
| The Recommended phase II dose of SHR-7787 injection monotherapy (stage I) | Expected to be two years after the start of the study. |
| Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I) | About 1 year after study initiation. |
| Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I) | About 1 year after study initiation. |
| Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I) | About 1 year after study initiation. |
| Objective response rate (ORR) (stage II) | Expected to be two years after the start of the study. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DoR) | About 1 year. |
| Disease Control Rate (DCR) | About 1 year. |
| Progress Free Survival (PFS) | About 1 year. |
| Overall Survival (OS) | About 1 year. |
| Objective response rate (ORR) | About 1 year. |
Countries
China
Contacts
Primary ContactXianhua Qiu
Outcome results
None listed