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This study is divided into two phases. Patients with recurrent or metastatic solid tumors accompanied by malignant ascites who have failed previous standard treatments are enrolled. The first phase is a single-arm, open-dose exploratory Phase I clinical study. In this phase, two dose groups are preset, namely 20×108 cells and 30×108 cells. Subjects who meet the inclusion criteria will receive intravenous infusion of SK-NK injection. Once a week for 6 consecutive infusions. After completing 6 consecutive infusions of SK-NK injection, the researchers evaluated that the patient benefited and could continue to receive 6 consecutive infusions of SK-NK injection. After completing 12 infusions, whether to continue the treatment subsequently could be determined based on the patient's condition. The second stage will be based on the results of the first stage to further verify the clinical efficacy, safety, tolerability and pharmacokinetic characteristics of RP2D, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1:Dose escalation stage | Experimental | "3+3" design. SK-NK injection, Two dose groups, namely 20×108 cells and 30×108 cells. |
|
| Phase 2:Expansion stage | Experimental | The dose of SK-NK injection selected based on the results of the first stage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SK-NK injection | Drug | In this stage, two dose groups are preset, namely 20×108 cells and 30×108 cells. Subjects who meet the inclusion criteria will receive intravenous infusion of SK-NK injection once a week for six consecutive times. After completing six consecutive infusions of SK-NK injection, the researchers evaluated that the patient benefited and could continue to receive six consecutive infusions of SK-NK injection. After completing twelve infusions, the decision on whether to continue the treatment subsequently could be made based on the patient's condition |
| Measure | Description | Time Frame |
|---|---|---|
| SK-NK injection safety and tolerance | The incidence of DLT,TEAEs and SAE, and the safety indicators before and after administration | up to 12 months |
| ORR | Antitumor efficacy of SK-NK injection | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) characteristics of SK-NK injection; | To evaluate the Cmax of SK-NK injection in patients with advanced or metastatic malignant solid tumors accompanied by malignant ascites | up to 12 months |
| DCR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TING DENG | Contact | 15802243063 | 18526812877@163.com |
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| SK-NK injection | Drug | Based on the dose selected from the results of the first stage, the clinical efficacy, safety, tolerability and pharmacokinetic characteristics of RP2D were further verified. The types of cancer and the number of cases enrolled in stage II are to be determined |
|
Disease control rate of SK-NK injection
| up to 12 months |
| PFS | Progression-free survival of SK-NK injection | up to 12 months |
| OS | The overall survival of the enrolled patients | up to 12 months |
| Pharmacokinetic (PK) characteristics of SK-NK injection | To evaluate the t1/2 of SK-NK injection in patients with advanced or metastatic malignant solid tumors accompanied by malignant ascites | up to 12months |
| Pharmacokinetic (PK) characteristics of SK-NK injection; | To evaluate the Tmax of SK-NK injection in patients with advanced or metastatic malignant solid tumors accompanied by malignant ascites | up to 12months |
| Pharmacokinetic (PK) characteristics of SK-NK injection; | To evaluate the AUC0-last of SK-NK injection in patients with advanced or metastatic malignant solid tumors accompanied by malignant ascites | up to 12months |