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

NCT06016270 | Terminated Phase 1 FDA Drug

• 1 other identifier: STCUBE-002
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 8

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.

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Progression Free Survival (PFS) rate

  Proportion of patients without documented progression of disease and alive at 6 months

  6 months

Secondary Outcomes (11)

• Safety and tolerability

  Up to 4 years

• Overall Response Rate (ORR)

  Up to 4 years

• Duration of Response (DoR)

  Up to 4 years

• Progression Free Survival (PFS)

  Up to 4 years

• Clinical Benefit Rate (CBR)

  Up to 4 years

Study Arms (2)

hSTC810 400 mg + Paclitaxel

EXPERIMENTAL

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

Drug: hSTC810 400 mg + Paclitaxel

hSTC810 800 mg + Paclitaxel

EXPERIMENTAL

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

Drug: hSTC810 800 mg + Paclitaxel

Interventions

hSTC810 400 mg + Paclitaxel DRUG

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 400 mg + Paclitaxel

hSTC810 800 mg + Paclitaxel DRUG

hSTC810 800 mg and paclitaxel 175 mg/m2 will be administered as an IV infusion

hSTC810 800 mg + Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• STCube, Inc.: lead

Study Sites (8)

Tisch Cancer Institute at Mount Sinai

New York, New York, 10029, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul National University Bundang Hospital

Seoul, 13620, South Korea

Location

The Catholic University of Korea St. Vincent's Hospital

Suwon, 16247, South Korea

Location

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 29, 2023
• Study Start: February 13, 2024
• Primary Completion: January 23, 2025
• Study Completion: August 25, 2025
• Last Updated: September 5, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); KR (6)