SB17170 Phase 1 Clinical Trial in Solid Tumors

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05522868
• Other study ID #: SMARTT-001
• Status: Recruiting
• Phase: Phase 1
• Start date: October 17, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: SPARK Biopharma
• Contact: Yongmi Yu
• Phone: 8228879905
• Email: ymyu[@]sparkbio.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• SB17170
SB17170 capsules, Oral administration 21days/cycle

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SPARK Biopharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetic(Cmax)	Peak Plasma Concentration	At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Secondary	Pharmacokinetic(Tmax)	Time to Peak Plasma Concentration	At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Secondary	Pharmacokinetic(AUC)	Area under the plasma concentration versus time curve	At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Secondary	The anti-tumor activity with RECIST v1.1	CT/MRI every 6 weeks	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 100weeks
Secondary	Pharmacodynamics(TIL)	Tumor infiltrated lymphocyte in Tumor tissue	At Day1 and D22 of Cycle 1 (each cycle is 21 days)
Secondary	Pharmacodynamics(TAM)	Tumor Associated Macrophage at Tumor Tissue	At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Secondary	Pharmacodynamics(T cell activation)	T cell activation in Blood	At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
Secondary	Pharmacodynamics(PD-L1)	PD-L1 in Blood and D1 of each cycle	At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
Secondary	Pharmacodynamics(High Mobility Group Box 1 )	HMGB1 in Blood and Tissue	At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
Secondary	Pharmacodynamics(S100A8)	S100A8 in Blood	At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days)
Secondary	Pharmacodynamics(S100A9)	S100A9 in Blood	At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Secondary	Pharmacodynamics(CXCL8)	CXCL8 in Blood	At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Secondary	Pharmacodynamics(MDSC)	Rate of Myeloid-Drived Suppressor Cell in Blood	At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)