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

SPARK Biopharma3 sites in 1 country50 target enrollmentOctober 17, 2022

ConditionsSolid Tumor

InterventionsSB17170

DrugsSB17170

Overview

Phase: Phase 1
Intervention: SB17170
Conditions: Solid Tumor
Sponsor: SPARK Biopharma
Enrollment: 50
Locations: 3
Primary Endpoint: Safety and tolerability of SB17170
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 17, 2022

End Date

December 30, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

SPARK Biopharma

Responsible Party

Sponsor

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
•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.

Arms & Interventions

Cohort 1

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

Intervention: SB17170

Cohort 2

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

Intervention: SB17170

Cohort 3

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

Intervention: SB17170

Outcomes

Primary Outcomes

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).

Secondary Outcomes

Pharmacokinetic(AUC)(At Day1 and D21 of Cycle 1 (each cycle is 21 days))
Pharmacodynamics(TIL)(At Day1 and D22 of Cycle 1 (each cycle is 21 days))
Pharmacokinetic(Cmax)(At Day1 and D21 of Cycle 1 (each cycle is 21 days))
Pharmacokinetic(Tmax)(At Day1 and D21 of Cycle 1 (each cycle is 21 days))
The anti-tumor activity with RECIST v1.1(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(S100A8)(At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days))
Pharmacodynamics(MDSC)(At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days))
Pharmacodynamics(S100A9)(At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days))
Pharmacodynamics(CXCL8)(At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days))
Pharmacodynamics(TAM)(At Day1 and D21 of Cycle 1 (each cycle is 21 days))
Pharmacodynamics(T cell activation)(At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days))
Pharmacodynamics(PD-L1)(At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days))
Pharmacodynamics(High Mobility Group Box 1 )(At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days))