RecruitingPhase 1NCT05522868

SB17170 Phase 1 Clinical Trial in Solid Tumors

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


Sponsor

SPARK Biopharma

Enrollment

50 participants

Start Date

Oct 17, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Phase 1 Open-label, multicenter, dose escalation, dose expansion study


Eligibility

Min Age: 19 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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.

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Interventions

DRUGSB17170

SB17170 capsules, Oral administration 21days/cycle


Locations(3)

Asan Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT05522868


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