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Trial Title:
SB17170 Phase 1 Clinical Trial in Solid Tumors
NCT ID:
NCT05522868
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Traditional 3+3 Dose Ascending design
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SB17170
Description:
SB17170 capsules, Oral administration 21days/cycle
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Arm group label:
Cohort 4
Arm group label:
Cohort 5
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.
Criteria for 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.
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Changhoon Yoo, M.D.
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Do-Youn Oh, M.D.
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
HyeJin Choi, M.D.
Start date:
October 17, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
SPARK Biopharma
Agency class:
Industry
Source:
SPARK Biopharma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05522868
