Solid TumorPhase 1NCT05522868
SB17170 Phase 1 Clinical Trial in Solid Tumors
A Phase 1 study testing SB17170 in people with Solid Tumor, run by SPARK Biopharma at 3 sites in South Korea.
Trial summary
Phase 1 Open-label, multicenter, dose escalation, dose expansion study Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- SB17170
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 17 Oct 2022to 30 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Not yet recruiting
Asan Medical Center
Seoul
Changhoon Yoo, M.D.
- Not yet recruiting
Seoul National University Hospital
Seoul
Do-Youn Oh, M.D.
- Recruiting
Severance Hospital
Seoul
HyeJin Choi, M.D.
About this study
Official 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
Phase 1 Open-label, multicenter, dose escalation, dose expansion study
Read the 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
- Being tested
- SB17170
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB17170Drug
SB17170 capsules, Oral administration 21days/cycle
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | SB17170 initial dose: 300 mg/d per day, 3 to 6 subjects per cohort Receives: Drug: SB17170 |
| Cohort 2 | Other | SB17170 dose: 600 mg/d per day, 3 to 6 subjects per cohort Receives: Drug: SB17170 |
| Cohort 3 | Other | SB17170 dose: 1000 mg/d per day, 3 to 6 subjects per cohort Receives: Drug: SB17170 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SB17170
Evaluate DLT to estimate the maximum tolerated dose (MTD), and determine a recommended Phase 2 dose (RP2D).
Measured: At the end of Cycle 1 (each cycle is 21 days)
Secondary outcomes (13)
Pharmacokinetic(Cmax)
Peak Plasma Concentration
Measured: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Pharmacokinetic(Tmax)
Time to Peak Plasma Concentration
Measured: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Pharmacokinetic(AUC)
Area under the plasma concentration versus time curve
Measured: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
The anti-tumor activity with RECIST v1.1
CT/MRI every 6 weeks
Measured: 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)
Tumor infiltrated lymphocyte in Tumor tissue
Measured: At Day1 and D22 of Cycle 1 (each cycle is 21 days)
Pharmacodynamics(TAM)
Tumor Associated Macrophage at Tumor Tissue
Measured: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Pharmacodynamics(T cell activation)
T cell activation in Blood
Measured: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
Pharmacodynamics(PD-L1)
PD-L1 in Blood and D1 of each cycle
Measured: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
Pharmacodynamics(High Mobility Group Box 1 )
HMGB1 in Blood and Tissue
Measured: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
Pharmacodynamics(S100A8)
S100A8 in Blood
Measured: At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days)
Pharmacodynamics(S100A9)
S100A9 in Blood
Measured: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Pharmacodynamics(CXCL8)
CXCL8 in Blood
Measured: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Pharmacodynamics(MDSC)
Rate of Myeloid-Drived Suppressor Cell in Blood
Measured: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start17 Oct 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Traditional 3+3 Dose Ascending design
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPARK Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soojin Jun, Study director, SPARK Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522868
- Sponsor's protocol ID
- SMARTT-001
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05522868
- Acronym / sponsor ID
- SMARTT-001
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SPARK BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Traditional 3+3 Dose Ascending design
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: SB17170SB17170 initial dose: 300 mg/d per day, 3 to 6 subjects per cohort |
| Cohort 2 | Other | Drug: SB17170SB17170 dose: 600 mg/d per day, 3 to 6 subjects per cohort |
| Cohort 3 | Other | Drug: SB17170SB17170 dose: 1000 mg/d per day, 3 to 6 subjects per cohort |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB17170SB17170 capsules, Oral administration 21days/cycle | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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).
13 secondary outcomes
Pharmacokinetic(Cmax)
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Pharmacokinetic(Tmax)
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Pharmacokinetic(AUC)
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
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
Pharmacodynamics(TIL)
Time frame: At Day1 and D22 of Cycle 1 (each cycle is 21 days)
Pharmacodynamics(TAM)
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Pharmacodynamics(T cell activation)
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
Pharmacodynamics(PD-L1)
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
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)
Pharmacodynamics(S100A8)
Time frame: At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days)
Pharmacodynamics(S100A9)
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Pharmacodynamics(CXCL8)
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Pharmacodynamics(MDSC)
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soojin Jun study director
SPARK Biopharma
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB17170 in people with Solid Tumor, run by SPARK Biopharma at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun Bin Kang (8228879905, sbkang@sparkbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of SB17170 (time frame: At the end of Cycle 1 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.