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

Extensive Stage Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016270
• Other study ID #: STCUBE-002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 13, 2024
• Est. completion date: October 2027

Study information

• Verified date: August 2023
• Source: STCube, Inc.
• Contact: Jiwon Hur, MD
• Phone: 82-2-551-3370
• Email: hurjw[@]stcube.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 2027
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• hSTC810 400 mg + Paclitaxel
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
• hSTC810 800 mg + Paclitaxel
hSTC810 800 mg and paclitaxel 175 mg/m2 will be administered as an IV infusion

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea St. Vincent's Hospital	Suwon
United States	MD Anderson Cancer Center	Houston	Texas
United States	Tisch Cancer Institute at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
STCube, Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Primary	Progression Free Survival (PFS) rate	Proportion of patients without documented progression of disease and alive at 6 months	6 months
Secondary	Safety and tolerability	Incidence, causality, and nature of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to 4 years
Secondary	Overall Response Rate (ORR)	Investigator assessed ORR defined by RECIST 1.1	Up to 4 years
Secondary	Duration of Response (DoR)	Time from the date of first documented CR or PR until the date of documented progression or death	Up to 4 years
Secondary	Progression Free Survival (PFS)	Time from first dose until the date of objective disease progression or death	Up to 4 years
Secondary	Clinical Benefit Rate (CBR)	Percentage of evaluable patients with CR, PR, or Stable Disease (SD) lasting = 24 weeks	Up to 4 years
Secondary	Overall Survival (OS)	Time from first dose of study drug until the date of death	Up to 4 years
Secondary	Overall Survival (OS) rate	Proportion of patients alive at 12 months after the first dose of study drug	12 months
Secondary	Maximum plasma concentration (Cmax)	Maximum plasma concentration of hSTC810 to evaluate PK parameters	Up to 21 days
Secondary	Area under the concentration-time curve from 0 to 21 days (AUC0-21)	AUC from 0 to 21 days to evaluate PK parameters	Up to 21 days
Secondary	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	Up to 21 days
Secondary	Incidence of anti-drug antibodies (ADA)	Number and percentage of patients with positive ADAs	Up to 4 years