Solid Tumor
Conditions
Brief summary
Phase 1 Open-label, multicenter, dose escalation, dose expansion study
Detailed description
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.
Interventions
DRUGSB17170
SB17170 capsules, Oral administration 21days/cycle
Sponsors
SPARK Biopharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Traditional 3+3 Dose Ascending design
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A patient with a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors. * A person who has failed the known standard of care or has developed resistance to the standard of care and no longer has applicable standard of care * A patient with at least one measurable lesion according to the RECIST v1.1 criteria. * A person with Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1. * Those with an expected survival period of 3 months or more at the discretion of of the investigator.
Exclusion criteria
* A patient who has received drugs targeting High Mobility Group Box 1 (HMGB1). * A patient who has received or is undergoing chemotherapy (including chemotherapy, radiation therapy, immunotherapy, hormone therapy, targeted therapy, biological products, and tumor embolization) within 28 days from the first administration date of the investigational drug. * A person who needs to take contraindicated drugs or is expected to take them during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of SB17170 | At the end of Cycle 1 (each cycle is 21 days) | Evaluate DLT to estimate the maximum tolerated dose (MTD), and determine a recommended Phase 2 dose (RP2D). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic(Cmax) | At Day1 and D21 of Cycle 1 (each cycle is 21 days) | Peak Plasma Concentration |
| Pharmacokinetic(Tmax) | At Day1 and D21 of Cycle 1 (each cycle is 21 days) | Time to Peak Plasma Concentration |
| Pharmacokinetic(AUC) | At Day1 and D21 of Cycle 1 (each cycle is 21 days) | Area under the plasma concentration versus time curve |
| The anti-tumor activity with RECIST v1.1 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 100weeks | CT/MRI every 6 weeks |
| Pharmacodynamics(TIL) | At Day1 and D22 of Cycle 1 (each cycle is 21 days) | Tumor infiltrated lymphocyte in Tumor tissue |
| Pharmacodynamics(TAM) | At Day1 and D21 of Cycle 1 (each cycle is 21 days) | Tumor Associated Macrophage at Tumor Tissue |
| Pharmacodynamics(S100A8) | At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days) | S100A8 in Blood |
| Pharmacodynamics(PD-L1) | At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days) | PD-L1 in Blood and D1 of each cycle |
| Pharmacodynamics(High Mobility Group Box 1 ) | At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days) | HMGB1 in Blood and Tissue |
| Pharmacodynamics(S100A9) | At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days) | S100A9 in Blood |
| Pharmacodynamics(CXCL8) | At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days) | CXCL8 in Blood |
| Pharmacodynamics(MDSC) | At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days) | Rate of Myeloid-Drived Suppressor Cell in Blood |
| Pharmacodynamics(T cell activation) | At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days) | T cell activation in Blood |
Countries
South Korea
Contacts
Primary ContactSun Bin Kang
Outcome results
None listed