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This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 intratumoral in patients with advanced solid tumors.
This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 intratumoral in patients with advanced solid tumors.The dose increasing method of "BLRM" is used to explore the safety, tolerance and determine the maximum tolerated dose(MTD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | KL340399 weekly on Days 1, 8 and 15 on repeated 21-day cycles in escalating doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KL340399 Intratumoral | Drug | KL340399 is a STING-activating. The strength of KL340399 is 0.2 mg/vial or 0.2 mg/vial. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects achieving Dose-limiting toxicity (DLT) | DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug. | From data of initial dose until up to 21 days for treatment |
| Maximum Tolerated Dose (MTD) | The maximum tolerated dose (MTD) is refers to the highest dose at which the patient's DLT incidence exceeding 33% during the first cycle. | From data of initial dose until up to 21 days for treatment |
| Incidence of Adverse Events [Safety and Tolerability] | Incidence of adverse events of KL340399 as a monotherapy as determined by patient reporting, clinical laboratory test changes from baseline, and clinically significant changes in physical examination data. | Up to 24 months |
| Recommended Phase 2 Dose (RP2D) | The recommended phase 2 dose (RP2D) will be based on a consideration of the totality of data including but not limited to safety data (including DLTs), PK, PD and preliminary efficacy, as available. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases. | Up to 24 months |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Guo, Dr. | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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PFS: Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
| Up to 24 months |
| Duration of Response (DOR) | DOR: Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason. | Up to 24 months |
| Overall Survival (OS) | OS: Time from start of treatment to death due to any reason. | Up to 24 months |