Clinical trial NCT05522868: SB17170 Phase 1 Clinical Trial in Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: SPARK Biopharma
Sponsor class: INDUSTRY
First posted: 2022-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Traditional 3+3 Dose Ascending design
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety and tolerability of SB17170
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
Secondary outcomes:
measure: Pharmacokinetic(Cmax)
timeFrame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
measure: Pharmacokinetic(Tmax)
timeFrame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
measure: Pharmacokinetic(AUC)
timeFrame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
measure: The anti-tumor activity with RECIST v1.1
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 100weeks
measure: Pharmacodynamics(TIL)
timeFrame: At Day1 and D22 of Cycle 1 (each cycle is 21 days)
measure: Pharmacodynamics(TAM)
timeFrame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
measure: Pharmacodynamics(T cell activation)
timeFrame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
measure: Pharmacodynamics(PD-L1)
timeFrame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
measure: Pharmacodynamics(High Mobility Group Box 1 )
timeFrame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
measure: Pharmacodynamics(S100A8)
timeFrame: At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days)
measure: Pharmacodynamics(S100A9)
timeFrame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
measure: Pharmacodynamics(CXCL8)
timeFrame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
measure: Pharmacodynamics(MDSC)
timeFrame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: SPARK Biopharma
name: Soojin Jun
role: STUDY_DIRECTOR
References: