Clinical trial NCT05231746: A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)
Official title: A Phase 1, Multicenter, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of hSTC810 Monotherapy in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: Immune Checkpoint Inhibitors
Antineoplastic Agents
Therapeutic Uses
Colorectal Neoplasms
Head and Neck Neoplasms
Ovarian Neoplasms
Urinary Bladder Neoplasms
Lung Neoplasms
Antibodies, Monoclonal
anti-BTN1A1
butyrophilins
Lead sponsor: STCube, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-09
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of DLTs
timeFrame: 4 weeks
measure: Incidence of AEs, SAEs, and abnormalities in Lab
timeFrame: from signing ICF to 90 days after last dose
Secondary outcomes:
measure: Peak plasma concentration (Cmax)
timeFrame: Up to 2 years
measure: Minimum plasma concentration (Cmin)
timeFrame: Up to 2 years
measure: Time to maximum plasma concentration (Tmax)
timeFrame: Up to 2 years
measure: Area under the plasma concentration - time curve (AUC0-t)
timeFrame: Up to 2 years
measure: Incidence of ADA
timeFrame: Up to 2 years
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
measure: Best overall response (BOR)
timeFrame: Up to 2 years
measure: Clinical Benefit rate (CBR)
timeFrame: Up to 2 years
measure: Duration of response (DoR)
timeFrame: Up to 2 years
measure: Progression free survival (PFS)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: STCube, Inc.
name: Medical director
role: STUDY_DIRECTOR
References: