Study on hSTC810 and Paclitaxel for Treating Relapsed or Hard-to-Treat Extensive Stage Small Cell Lung Cancer

Sponsor: STCube, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06016270

Provider View

This clinical trial is testing a new combination of drugs, hSTC810 and paclitaxel, to see if they are safe and effective for patients with extensive stage small cell lung cancer that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The aim of this study is to find out if a new combination of drugs, hSTC810 and paclitaxel, can safely and effectively treat patients with extensive stage small cell lung cancer (ES-SCLC) that has come back or not responded to earlier treatments. The study will be conducted in two parts: the first part will focus on the safety of the drug combination, and the second part will evaluate how well the combination works in treating the cancer.

Description

The study is divided into two phases. In Phase Ib, researchers will test the safety of combining hSTC810 with paclitaxel by gradually increasing the dose to find the safest amount. In Phase II, the effectiveness of this drug combination will be assessed to see if it can help control the cancer. Participants will receive the combination therapy and be closely monitored for any side effects and improvements in their condition.

Eligibility Criteria

Inclusion Criteria

  • Be able to understand and sign a consent form.
  • Be 18 years or older.
  • Have a confirmed diagnosis of small cell lung cancer (SCLC).
  • Have cancer that has returned or not responded after platinum-based chemotherapy.
  • Have at least one tumor that can be measured by scans.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 3 months.
  • Have adequate organ function as specified in the study protocol.
  • Agree to use contraception during the study and for at least 5 months after the last dose if of reproductive potential.

Exclusion Criteria

  • Have active cancer in the brain or spinal cord.
  • Have received certain treatments like immunotherapy or chemotherapy within 14 days before starting the study treatment.
  • Have had major surgery within 21 days before starting the study treatment.
  • Have received a live vaccine within 30 days before starting the study treatment.
  • Have another type of cancer, with some exceptions.
  • Have an autoimmune disease that requires treatment.
  • Be taking high doses of steroids or other medications that suppress the immune system.
  • Have active hepatitis B or C infection.
  • Have a history of lung inflammation requiring steroid treatment.
  • Have an uncontrolled infection, including tuberculosis.
  • Be pregnant or breastfeeding.
  • Have had severe allergic reactions to similar treatments.
  • Have had recent heart problems or symptoms.
  • Have a prolonged QT interval on an ECG (QTcF greater than 470 milliseconds).
  • Have unresolved side effects from previous treatments, except for hair loss.
  • Have any condition or lab abnormality that could interfere with participation in the study.
  • Have a known psychiatric or substance use disorder.
  • Test positive for COVID-19 at screening.

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