SB17170 Phase 1 Clinical Trial in Solid Tumors

SPARK Biopharma

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor

Treatments: Drug: SB17170

Study type: Interventional

Funder types: Industry

Identifiers

NCT05522868

SMARTT-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 5 patient groups

Cohort 1

Other group

Description:

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

Treatment:

Drug: SB17170

Cohort 2

Other group

Description:

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

Treatment:

Drug: SB17170

Cohort 3

Other group

Description:

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

Treatment:

Drug: SB17170

Cohort 4

Other group

Description:

SB17170 dose: 1500 mg/d per day, 3 to 6 subjects per cohort

Treatment:

Drug: SB17170

Cohort 5

Other group

Description:

SB17170 dose: 2000 mg/d per day, 3 to 6 subjects per cohort

Treatment:

Drug: SB17170