A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)

STCube

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Biological: hSTC810

Study type

Interventional

Funder types

Industry

Identifiers

NCT05231746

STCUBE-001

Details and patient eligibility

About

The Purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hSTC810 monotherapy in participants with advanced solid tumors.

Full description

The study consists of a dose-escalation phase that will evaluate 6 dosing schedules of hSTC810. The first cohort will be single participant cohort. Subsequent escalation cohorts will use a standard 3+3 design, with the ability to backfill up to an additional 6 patients in each dose cohort.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female aged at 18 ≥ years
Capable and willing to give signed informed consent
At least one measurable lesion as determined by RECIST Ver.1.1
ECOG PS score ≤ 1
Expected survival ≥ 12 weeks
For female or male patients of reproductive potential: Agree to use contraception throughout the study and at least 6 months after the last dose.

Exclusion criteria

Subject who has received anti-cancer treatment within 4 weeks prior to the first dose of study treatment.
Subject who has received radiotherapy or major surgery within 4 weeks prior to screening.
Any toxicity due to prior therapy that has not resolved to ≤ Grade 1 or returned to baseline by the time of starting study treatment.
Subject with known severe (≥Grade 3) hypersensitivity to any checkpoint inhibitor.
Clinically significant laboratory abnormalities.
Subject with a history of another invasive malignancy within 3 years before the first dose of study drug.
Subject with active central nervous system (CNS) metastases.
Subject who requires high dose of steroids or other immunosuppressive medications.
Subject with a history of autoimmune disease that has required systemic treatment in the past 2 years.
Subject with active infection that requires systemic antimicrobial treatment.
Subject with active HBV or HCV infection.
Subject who has a known history of HIV infection.
Subject with active tuberculosis.
Subject with a documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class IV within 6 months prior to screening.
Subject with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening CT scan.
Subject who has received a prior allogeneic stem cell or solid organ transplant.
Subject with a positive coronavirus disease (COVID) test during screening.
Subjects who have received a live attenuated vaccine within 30 days prior to screening.
Subject with another underlying medical condition.