SB17170 Phase 1 Clinical Trial in Solid Tumors

Study Overview
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Brief Summary
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Phase 1 Open-label, multicenter, dose escalation, dose expansion study

Detailed Description
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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.

Official Title
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An Open-label, Multicenter, Phase 1 Clinical Trial to Evaluate MTD, Safety, PK/PD and Preliminary Anti-tumor Activity of SB17170 in Patients With Locally Advanced or Metastatic Solid Tumors Who Have Failed Standard of Care

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: SB17170


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Traditional 3+3 Dose Ascending design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort 1<br>SB17170 initial dose: 300 mg/d per day, 3 to 6 subjects per cohort | Drug: SB17170<br>* SB17170 capsules, Oral administration 21days/cycle<br>|
| Other: Cohort 2<br>SB17170 dose: 600 mg/d per day, 3 to 6 subjects per cohort | Drug: SB17170<br>* SB17170 capsules, Oral administration 21days/cycle<br>|
| Other: Cohort 3<br>SB17170 dose: 1000 mg/d per day, 3 to 6 subjects per cohort | Drug: SB17170<br>* SB17170 capsules, Oral administration 21days/cycle<br>|
| Other: Cohort 4<br>SB17170 dose: 1500 mg/d per day, 3 to 6 subjects per cohort | Drug: SB17170<br>* SB17170 capsules, Oral administration 21days/cycle<br>|
| Other: Cohort 5<br>SB17170 dose: 2000 mg/d per day, 3 to 6 subjects per cohort | Drug: SB17170<br>* SB17170 capsules, Oral administration 21days/cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |