SB17170
DrugSB17170 capsules, Oral administration 21days/cycle
NCT Number: NCT05522868
Phase 1 Open-label, multicenter, dose escalation, dose expansion study
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Phase 1
Asan Medical Center, Seoul, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SB17170 capsules, Oral administration 21days/cycle
Time frame: 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).
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Peak Plasma Concentration
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Time to Peak Plasma Concentration
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Area under the plasma concentration versus time curve
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
CT/MRI every 6 weeks
Time frame: At Day1 and D22 of Cycle 1 (each cycle is 21 days)
Tumor infiltrated lymphocyte in Tumor tissue
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Tumor Associated Macrophage at Tumor Tissue
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
T cell activation in Blood
Time frame: 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
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
HMGB1 in Blood and Tissue
Time frame: At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days)
S100A8 in Blood
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
S100A9 in Blood
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
CXCL8 in Blood
Time frame: 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
Contact information is provided by the study sponsor or research team.
SPARK Biopharma
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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