SB17170 Phase 1 Clinical Trial in Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SB17170.
- Who it may be relevant to
- Registry conditions: Solid Tumor. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug SB17170
SB17170 capsules, Oral administration 21days/cycle
Primary outcome measures
- Safety and tolerability of SB17170 [Time frame: At the end of Cycle 1 (each cycle is 21 days)]
Secondary outcome measures (12)
- Pharmacokinetic(Cmax) [Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)]
- Pharmacokinetic(Tmax) [Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)]
- Pharmacokinetic(AUC) [Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)]
- The anti-tumor activity with RECIST v1.1 [Time frame: 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) [Time frame: At Day1 and D22 of Cycle 1 (each cycle is 21 days)]
- Pharmacodynamics(TAM) [Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)]
- Pharmacodynamics(T cell activation) [Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)]
- Pharmacodynamics(PD-L1) [Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)]
- Pharmacodynamics(High Mobility Group Box 1 ) [Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)]
- Pharmacodynamics(S100A8) [Time frame: At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days)]
- Pharmacodynamics(S100A9) [Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)]
- Pharmacodynamics(CXCL8) [Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 3 centers
- Asan Medical Center — Seoul
- Seoul National University Hospital — Seoul
- Severance Hospital — Seoul
Identifiers
NCT: NCT05522868 · SMARTT-001