Lung Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT06016270

Recruitment Status:

Recruiting

Sponsor:

STCube, Inc.

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There are 8 Locations for this study

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Tisch Cancer Institute at Mount Sinai
New York New York, 10029, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Seoul National University Bundang Hospital
Seoul , 13620, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital
Suwon , 16247, Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT06016270

Recruitment Status:

Recruiting

Sponsor:


STCube, Inc.

How clear is this clinincal trial information?

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