SB17170 Phase 1 Clinical Trial in Solid Tumors

NCT05522868 | Recruiting Phase 1

• 1 other identifier: SMARTT-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of SB17170

  Evaluate DLT to estimate the maximum tolerated dose (MTD), and determine a recommended Phase 2 dose (RP2D).

  At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcomes (13)

• Pharmacokinetic(Cmax)

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

• Pharmacokinetic(Tmax)

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

• Pharmacokinetic(AUC)

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

• The anti-tumor activity with RECIST v1.1

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 100weeks

• Pharmacodynamics(TIL)

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

Study Arms (3)

Cohort 1

OTHER

SB17170 initial dose: 300 mg/d per day, 3 to 6 subjects per cohort

Drug: SB17170

Cohort 2

OTHER

SB17170 dose: 600 mg/d per day, 3 to 6 subjects per cohort

Drug: SB17170

Cohort 3

OTHER

SB17170 dose: 1000 mg/d per day, 3 to 6 subjects per cohort

Drug: SB17170

Interventions

SB17170 DRUG

SB17170 capsules, Oral administration 21days/cycle

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SPARK Biopharma: lead

Study Sites (3)

Asan Medical Center

Seoul, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, South Korea

NOT YET RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Soojin Jun

  SPARK Biopharma

  STUDY DIRECTOR

Central Study Contacts

Sun Bin Kang

CONTACT

8228879905; sbkang@sparkbio.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Traditional 3+3 Dose Ascending design

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 31, 2022
• Study Start: October 17, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)