TERMINATED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-13

Study Completion:2025-08-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06016270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Locations (Sites)

Tisch Cancer Institute at Mount Sinai

New York, New York, 10029

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: STCube, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-13

Study Completion Date2025-08-25

Study Record Updates

Study Start Date2024-02-13

Study Completion Date2025-08-25

Terms related to this study

Additional Relevant MeSH Terms

Extensive Stage Small Cell Lung Cancer