SB17170 Phase 1 Clinical Trial in Solid Tumors

NCT ID: NCT05522868

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2027-12-30

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

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

Group Type: OTHER

SB17170

Intervention Type: DRUG

SB17170 capsules, Oral administration 21days/cycle

Cohort 2

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

Group Type: OTHER

SB17170

Intervention Type: DRUG

SB17170 capsules, Oral administration 21days/cycle

Cohort 3

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

Group Type: OTHER

SB17170

Intervention Type: DRUG

SB17170 capsules, Oral administration 21days/cycle

Interventions

SB17170

SB17170 capsules, Oral administration 21days/cycle

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SPARK Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soojin Jun

Role: STUDY_DIRECTOR

SPARK Biopharma

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: NOT_YET_RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status: NOT_YET_RECRUITING

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sun Bin Kang

Role: CONTACT

sbkang@sparkbio.co.kr

8228879905

Facility Contacts

Changhoon Yoo, M.D.

Role: primary

Do-Youn Oh, M.D.

Role: primary

HyeJin Choi, M.D.

Role: primary

Other Identifiers

SMARTT-001

Identifier Type: -

Identifier Source: org_study_id