SB17170 for advanced and metastatic 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

This trial tests SB17170 alone or with standard treatments in adults with advanced or metastatic solid tumors who have exhausted standard options to see if it is safe and shows anti-tumor activity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: SPARK Biopharma (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 3 sites (Seoul and 2 other locations)
• Trial ID: NCT05522868 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter Phase 1 dose-escalation and dose-expansion trial of SB17170 given alone (part 1a) and together with standard-of-care therapies (part 1b) in patients with locally advanced or metastatic solid tumors who have failed available treatments. The study will determine the maximum tolerated dose, safety profile, pharmacokinetics/pharmacodynamics, and collect preliminary evidence of anti-tumor activity. Treatment is given in 21-day cycles with tumor assessments every two cycles. Eligible patients must have measurable disease by RECIST v1.1 and an ECOG performance status of 0 or 1.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed locally advanced or metastatic solid tumors, at least one measurable lesion, ECOG 0–1, who have progressed on or are no longer eligible for standard treatments and are expected to survive at least three months.

Not a fit: Patients who recently received other systemic cancer therapies within 28 days, who have previously received HMGB1-targeting drugs, or who have poor performance status or very limited life expectancy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, SB17170 could provide a new treatment option that shrinks tumors or prolongs life for patients who no longer have standard therapies.

How similar studies have performed: Targeting HMGB1 and related pathways is a relatively novel approach with encouraging preclinical data but limited clinical experience to date.

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.

Where this trial is running

Seoul and 2 other locations

• 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 contacts

• Study coordinator: Sun Bin Kang

Conditions Solid Tumor