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Phase 1 Open-label, multicenter, dose escalation, dose expansion study
This is an open-label, multicenter, Phase 1 clinical trial to evaluate the maximum tolerated dose, safety, pharmacokinetic/pharmacodynamic characteristics and preliminary anti-tumor activity of SB17170 when administered alone(1a) and co-administered with standard of care(1b) to patients with locally advanced or metastatic solid tumors who have failed standard of care.
1 cycle of treatment of this clinical trial is 21 days, and tumors are assessed every 2 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | SB17170 initial dose: 300 mg/d per day, 3 to 6 subjects per cohort |
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| Cohort 2 | Other | SB17170 dose: 600 mg/d per day, 3 to 6 subjects per cohort |
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| Cohort 3 | Other | SB17170 dose: 1000 mg/d per day, 3 to 6 subjects per cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB17170 | Drug | SB17170 capsules, Oral administration 21days/cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of SB17170 | Evaluate DLT to estimate the maximum tolerated dose (MTD), and determine a recommended Phase 2 dose (RP2D). | At the end of Cycle 1 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic(Cmax) | Peak Plasma Concentration | At Day1 and D21 of Cycle 1 (each cycle is 21 days) |
| Pharmacokinetic(Tmax) | Time to Peak Plasma Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun Bin Kang | Contact | 8228879905 | sbkang@sparkbio.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Soojin Jun | SPARK Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Not yet recruiting | Seoul | South Korea |
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Traditional 3+3 Dose Ascending design
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| At Day1 and D21 of Cycle 1 (each cycle is 21 days) |
| Pharmacokinetic(AUC) | Area under the plasma concentration versus time curve | At Day1 and D21 of Cycle 1 (each cycle is 21 days) |
| The anti-tumor activity with RECIST v1.1 | CT/MRI every 6 weeks | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 100weeks |
| Pharmacodynamics(TIL) | Tumor infiltrated lymphocyte in Tumor tissue | At Day1 and D22 of Cycle 1 (each cycle is 21 days) |
| Pharmacodynamics(TAM) | Tumor Associated Macrophage at Tumor Tissue | At Day1 and D21 of Cycle 1 (each cycle is 21 days) |
| Pharmacodynamics(T cell activation) | T cell activation in Blood | At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days) |
| Pharmacodynamics(PD-L1) | PD-L1 in Blood and D1 of each cycle | At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days) |
| Pharmacodynamics(High Mobility Group Box 1 ) | HMGB1 in Blood and Tissue | At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days) |
| Pharmacodynamics(S100A8) | S100A8 in Blood | At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days) |
| Pharmacodynamics(S100A9) | S100A9 in Blood | At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days) |
| Pharmacodynamics(CXCL8) | CXCL8 in Blood | At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days) |
| Pharmacodynamics(MDSC) | Rate of Myeloid-Drived Suppressor Cell in Blood | At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days) |
| Seoul National University Hospital | Not yet recruiting | Seoul | South Korea |
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| Severance Hospital | Recruiting | Seoul | South Korea |
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