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Trial Title:
A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
NCT ID:
NCT06016270
Condition:
Extensive Stage Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
hSTC810 400 mg + Paclitaxel
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
Arm group label:
hSTC810 400 mg + Paclitaxel
Intervention type:
Drug
Intervention name:
hSTC810 800 mg + Paclitaxel
Description:
hSTC810 800 mg and paclitaxel 175 mg/m2 will be administered as an IV infusion
Arm group label:
hSTC810 800 mg + Paclitaxel
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tisch Cancer Institute at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seoul
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea St. Vincent's Hospital
Address:
City:
Suwon
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Start date:
February 13, 2024
Completion date:
October 2027
Lead sponsor:
Agency:
STCube, Inc.
Agency class:
Industry
Source:
STCube, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06016270
