SB17170 Phase 1 Clinical Trial in 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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: SB17170

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yongmi Yu; Phone Number: 8228879905; Email: ymyu@sparkbio.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital
    • Contact: HyeJin Choi, M.D.
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Asan Medical Center
    • Contact: Changhoon Yoo, M.D.
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Seoul National University Hospital
    • Contact: Do-Youn Oh, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort 1; SB17170 initial dose: 300 mg/d per day, 3 to 6 subjects per cohort	Drug: SB17170; SB17170 capsules, Oral administration 21days/cycle
Other: Cohort 2; SB17170 dose: 600 mg/d per day, 3 to 6 subjects per cohort	Drug: SB17170; SB17170 capsules, Oral administration 21days/cycle
Other: Cohort 3; SB17170 dose: 1000 mg/d per day, 3 to 6 subjects per cohort	Drug: SB17170; SB17170 capsules, Oral administration 21days/cycle
Other: Cohort 4; SB17170 dose: 1500 mg/d per day, 3 to 6 subjects per cohort	Drug: SB17170; SB17170 capsules, Oral administration 21days/cycle
Other: Cohort 5; SB17170 dose: 2000 mg/d per day, 3 to 6 subjects per cohort	Drug: SB17170; SB17170 capsules, Oral administration 21days/cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic(Cmax)	Peak Plasma Concentration	At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Pharmacokinetic(Tmax)	Time to Peak Plasma Concentration	At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Pharmacokinetic(AUC)	Area under the plasma concentration versus time curve	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	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	At Day1 and D22 of Cycle 1 (each cycle is 21 days)
Pharmacodynamics(TAM)	Tumor Associated Macrophage at Tumor Tissue	At Day1 and D21 of Cycle 1 (each cycle is 21 days)
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)
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)
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)
Pharmacodynamics(S100A8)	S100A8 in Blood	At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days)
Pharmacodynamics(S100A9)	S100A9 in Blood	At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Pharmacodynamics(CXCL8)	CXCL8 in Blood	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	At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)

Collaborators and Investigators

• Sponsor: SPARK Biopharma
• Investigators: Study Director: Soojin Jun, SPARK Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 28, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SMARTT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No