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Monoclonal Antibodies

hSTC810 400 mg + Paclitaxel for Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by STCube, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed SCLC

R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease progression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of using a combination of hSTC810 and paclitaxel treatment in patients with advanced small cell lung cancer that has come back or not responded to

Who is the study for?

This trial is for adults over 18 with small cell lung cancer that has come back or didn't respond to platinum-based chemo. They should have a life expectancy of at least 3 months, be able to understand the study and agree to use contraception. They must have at least one tumor that can be measured and be in fairly good health (ECOG PS of 0 or 1).Check my eligibility

What is being tested?

The trial is testing two different doses of hSTC810 combined with Paclitaxel in patients whose extensive stage small cell lung cancer has relapsed or hasn't responded after initial treatment. The goal is to see how safe this combination is and how well it works.See study design

What are the potential side effects?

Possible side effects from hSTC810 and Paclitaxel may include allergic reactions, nerve damage causing pain or numbness, muscle aches, hair loss, nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My small cell lung cancer diagnosis was confirmed through lab tests.

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My small cell lung cancer returned or worsened after platinum-based treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) rate

Secondary outcome measures

Area under the concentration-time curve extrapolated from 0 to infinity (AUCo-inf)

Area under the concentration-time curve from 0 to 21 days (AUC0-21)

Clinical Benefit Rate (CBR)

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: hSTC810 800 mg + PaclitaxelExperimental Treatment1 Intervention

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

Group II: hSTC810 400 mg + PaclitaxelExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

STCube, Inc.Lead Sponsor

1 Previous Clinical Trials

47 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients to participate in this clinical trial?

"According to the current information available on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The trial was initially posted for recruitment purposes on January 1st, 2024 and underwent its most recent update on January 5th, 2024."

Answered by AI

What is the total number of participants currently under investigation in this clinical study?

"Indeed, the information on clinicaltrials.gov indicates that this study is actively seeking eligible participants. The trial was initially posted on January 1st, 2024 and most recently updated on January 5th, 2024. A total of 130 patients will be enrolled across eight different sites."

Answered by AI

At how many different venues is this experimental investigation currently being supervised?

"Among the participating sites, Seoul National University Bundang Hospital in Houston, MD Anderson Cancer Center in New york, and Tisch Cancer Institute at Mount Sinai in Suwon are actively recruiting patients. Additionally, there are 8 other locations where patient recruitment is ongoing for this clinical trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06016270.