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

NCT05231746 | Completed Phase 1 FDA Drug

• 1 other identifier: STCUBE-001
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (2)

• Incidence of DLTs

  Number and percentages of subjects with DLTs

  4 weeks

• Incidence of AEs, SAEs, and abnormalities in Lab

  Number and percentages of subjects with Adverse Event, serious AEs, and abnormalities in lab parameters

  from signing ICF to 90 days after last dose

Secondary Outcomes (11)

• Peak plasma concentration (Cmax)

  Up to 2 years

• Minimum plasma concentration (Cmin)

  Up to 2 years

• Time to maximum plasma concentration (Tmax)

  Up to 2 years

• Area under the plasma concentration - time curve (AUC0-t)

  Up to 2 years

• Incidence of ADA

  Up to 2 years

Study Arms (1)

hSTC810

EXPERIMENTAL

6 escalating doses of hSTC810 will be administered to participants

Biological: hSTC810

Interventions

hSTC810 BIOLOGICAL

hSTC810 will be administered as an intravenous infusion (IV)

hSTC810

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• STCube, Inc.: lead

Study Sites (5)

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Yonsei University Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Head and Neck Neoplasms; Ovarian Neoplasms; Urinary Bladder Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical director

  STCube, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 9, 2022
• Study Start: April 18, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 13, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2); US (3)