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A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer

Primary Purpose

Extensive Stage Small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
hSTC810 400 mg + Paclitaxel
hSTC810 800 mg + Paclitaxel
Sponsored by
STCube, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ability to understand and sign an informed consent form Male or female ≥ 18 years of age Histologically or cytologically confirmed SCLC R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease progression At least 1 measurable lesion as defined by RECIST 1.1 Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 or 1 Life expectancy of at least 3 months Adequate organ function as described in the protocol For female or male patients with reproductive potential: Agree to use contraception throughout the study and at least 5 months after the last dose. Exclusion Criteria: Known active leptomeningeal disease (carcinomatous meningitis) Known active and uncontrolled central nervous system (CNS) metastases Treatment with immunotherapy, chemotherapy, targeted small molecule therapy, or any other investigational agent < 14 days prior to initiation of study treatment Treatment with radiation therapy < 14 days prior to initiation of study treatment Major surgery < 21 days prior to initiation of study treatment Received live vaccine < 30 days prior to initiation of study treatment, including intranasal influenza vaccine History of another primary malignancy with protocol-defined exceptions Active or history of autoimmune disease requiring systemic treatment Receiving high doses of steroids or other immunosuppressive medications Active hepatitis B or C infection Active or history of non-infectious pneumonitis requiring treatment with steroids Active uncontrolled viral, fungal, or bacterial infection including tuberculosis Pregnant or breastfeeding female patients History of severe hypersensitivity reaction to a monoclonal antibody treatment History of severe hypersensitivity reaction or ≥ Grade 3 adverse event (AE) to paclitaxel treatment History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to screening QT Corrected for Fridericia's method (QTcF) > 470 ms at screening Lack of resolution of any toxicity to max Grade 1 (except alopecia) Active or history of any condition, therapy, or lab abnormality that may interfere with the patient participation for the full duration of the study Known psychiatric or substance use disorder Positive Coronavirus disease 2019 (COVID-19) test at screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    hSTC810 400 mg + Paclitaxel

    hSTC810 800 mg + Paclitaxel

    Arm Description

    hSTC810 400 mg will be administered with a standard dose of paclitaxel

    hSTC810 800 mg will be administered with a standard dose of paclitaxel

    Outcomes

    Primary Outcome Measures

    Overall Response Rate (ORR)
    Percentage of patients with confirmed Confirmed Response (CR) or Partial Response (PR) as defined by RECIST 1.1 at 3 months
    Progression Free Survival (PFS) rate
    Proportion of patients without documented progression of disease and alive at 6 months

    Secondary Outcome Measures

    Safety and tolerability
    Incidence, causality, and nature of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    Overall Response Rate (ORR)
    Investigator assessed ORR defined by RECIST 1.1
    Duration of Response (DoR)
    Time from the date of first documented CR or PR until the date of documented progression or death
    Progression Free Survival (PFS)
    Time from first dose until the date of objective disease progression or death
    Clinical Benefit Rate (CBR)
    Percentage of evaluable patients with CR, PR, or Stable Disease (SD) lasting ≥ 24 weeks
    Overall Survival (OS)
    Time from first dose of study drug until the date of death
    Overall Survival (OS) rate
    Proportion of patients alive at 12 months after the first dose of study drug
    Maximum plasma concentration (Cmax)
    Maximum plasma concentration of hSTC810 to evaluate PK parameters
    Area under the concentration-time curve from 0 to 21 days (AUC0-21)
    AUC from 0 to 21 days to evaluate PK parameters
    Area under the concentration-time curve extrapolated from 0 to infinity (AUCo-inf)
    AUC from time 0 to infinity to evaluate total drug exposure over time
    Incidence of anti-drug antibodies (ADA)
    Number and percentage of patients with positive ADAs

    Full Information

    First Posted
    August 17, 2023
    Last Updated
    August 24, 2023
    Sponsor
    STCube, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06016270
    Brief Title
    A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
    Official Title
    A Phase Ib/II Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    October 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    STCube, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this clinical study is to assess the safety and efficacy of hSTC810 and paclitaxel combination therapy in patients with relapsed or refractory extensive stage small cell lung cancer.
    Detailed Description
    The study will be conducted in 2 parts. Phase Ib will evaluate the safety of the combination of hSTC810 with a standard dose of paclitaxel using a 3+3 dose escalation design. Phase II will evaluate the efficacy of hSTC810 + paclitaxel combination therapy using a Simon 2-stage method.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Extensive Stage Small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    hSTC810 400 mg + Paclitaxel
    Arm Type
    Experimental
    Arm Description
    hSTC810 400 mg will be administered with a standard dose of paclitaxel
    Arm Title
    hSTC810 800 mg + Paclitaxel
    Arm Type
    Experimental
    Arm Description
    hSTC810 800 mg will be administered with a standard dose of paclitaxel
    Intervention Type
    Drug
    Intervention Name(s)
    hSTC810 400 mg + Paclitaxel
    Intervention Description
    hSTC810 400 mg and paclitaxel 175 mg/m2 will be administered as an intravenous (IV) infusion Paclitaxel: 175 mg/m2 will be administered as an IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    hSTC810 800 mg + Paclitaxel
    Intervention Description
    hSTC810 800 mg and paclitaxel 175 mg/m2 will be administered as an IV infusion
    Primary Outcome Measure Information:
    Title
    Overall Response Rate (ORR)
    Description
    Percentage of patients with confirmed Confirmed Response (CR) or Partial Response (PR) as defined by RECIST 1.1 at 3 months
    Time Frame
    3 months
    Title
    Progression Free Survival (PFS) rate
    Description
    Proportion of patients without documented progression of disease and alive at 6 months
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Safety and tolerability
    Description
    Incidence, causality, and nature of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    Time Frame
    Up to 4 years
    Title
    Overall Response Rate (ORR)
    Description
    Investigator assessed ORR defined by RECIST 1.1
    Time Frame
    Up to 4 years
    Title
    Duration of Response (DoR)
    Description
    Time from the date of first documented CR or PR until the date of documented progression or death
    Time Frame
    Up to 4 years
    Title
    Progression Free Survival (PFS)
    Description
    Time from first dose until the date of objective disease progression or death
    Time Frame
    Up to 4 years
    Title
    Clinical Benefit Rate (CBR)
    Description
    Percentage of evaluable patients with CR, PR, or Stable Disease (SD) lasting ≥ 24 weeks
    Time Frame
    Up to 4 years
    Title
    Overall Survival (OS)
    Description
    Time from first dose of study drug until the date of death
    Time Frame
    Up to 4 years
    Title
    Overall Survival (OS) rate
    Description
    Proportion of patients alive at 12 months after the first dose of study drug
    Time Frame
    12 months
    Title
    Maximum plasma concentration (Cmax)
    Description
    Maximum plasma concentration of hSTC810 to evaluate PK parameters
    Time Frame
    Up to 21 days
    Title
    Area under the concentration-time curve from 0 to 21 days (AUC0-21)
    Description
    AUC from 0 to 21 days to evaluate PK parameters
    Time Frame
    Up to 21 days
    Title
    Area under the concentration-time curve extrapolated from 0 to infinity (AUCo-inf)
    Description
    AUC from time 0 to infinity to evaluate total drug exposure over time
    Time Frame
    Up to 21 days
    Title
    Incidence of anti-drug antibodies (ADA)
    Description
    Number and percentage of patients with positive ADAs
    Time Frame
    Up to 4 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability to understand and sign an informed consent form Male or female ≥ 18 years of age Histologically or cytologically confirmed SCLC R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease progression At least 1 measurable lesion as defined by RECIST 1.1 Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 or 1 Life expectancy of at least 3 months Adequate organ function as described in the protocol For female or male patients with reproductive potential: Agree to use contraception throughout the study and at least 5 months after the last dose. Exclusion Criteria: Known active leptomeningeal disease (carcinomatous meningitis) Known active and uncontrolled central nervous system (CNS) metastases Treatment with immunotherapy, chemotherapy, targeted small molecule therapy, or any other investigational agent < 14 days prior to initiation of study treatment Treatment with radiation therapy < 14 days prior to initiation of study treatment Major surgery < 21 days prior to initiation of study treatment Received live vaccine < 30 days prior to initiation of study treatment, including intranasal influenza vaccine History of another primary malignancy with protocol-defined exceptions Active or history of autoimmune disease requiring systemic treatment Receiving high doses of steroids or other immunosuppressive medications Active hepatitis B or C infection Active or history of non-infectious pneumonitis requiring treatment with steroids Active uncontrolled viral, fungal, or bacterial infection including tuberculosis Pregnant or breastfeeding female patients History of severe hypersensitivity reaction to a monoclonal antibody treatment History of severe hypersensitivity reaction or ≥ Grade 3 adverse event (AE) to paclitaxel treatment History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to screening QT Corrected for Fridericia's method (QTcF) > 470 ms at screening Lack of resolution of any toxicity to max Grade 1 (except alopecia) Active or history of any condition, therapy, or lab abnormality that may interfere with the patient participation for the full duration of the study Known psychiatric or substance use disorder Positive Coronavirus disease 2019 (COVID-19) test at screening
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jiwon Hur, MD
    Phone
    82-2-551-3370
    Email
    hurjw@stcube.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer

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