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NCT Number: NCT05522868

SB17170 Phase 1 Clinical Trial in Solid Tumors

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

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center, Seoul, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB17170

Drug

SB17170 capsules, Oral administration 21days/cycle

Primary outcomes

  1. Safety and tolerability of SB17170

    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).

Secondary outcomes

  1. Pharmacokinetic(Cmax)

    Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)

    Peak Plasma Concentration

  2. Pharmacokinetic(Tmax)

    Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)

    Time to Peak Plasma Concentration

  3. Pharmacokinetic(AUC)

    Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)

    Area under the plasma concentration versus time curve

  4. 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

    CT/MRI every 6 weeks

  5. Pharmacodynamics(TIL)

    Time frame: At Day1 and D22 of Cycle 1 (each cycle is 21 days)

    Tumor infiltrated lymphocyte in Tumor tissue

  6. Pharmacodynamics(TAM)

    Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)

    Tumor Associated Macrophage at Tumor Tissue

  7. Pharmacodynamics(T cell activation)

    Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)

    T cell activation in Blood

  8. Pharmacodynamics(PD-L1)

    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

  9. 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)

    HMGB1 in Blood and Tissue

  10. Pharmacodynamics(S100A8)

    Time frame: At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days)

    S100A8 in Blood

  11. Pharmacodynamics(S100A9)

    Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)

    S100A9 in Blood

  12. Pharmacodynamics(CXCL8)

    Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)

    CXCL8 in Blood

  13. Pharmacodynamics(MDSC)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sun Bin Kang

CONTACT

[email protected]

8228879905

Sponsors and collaborators

Lead sponsor

SPARK Biopharma

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2022
Registry last updated
Nov 20, 2025

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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