Study on New Treatment for Advanced Solid Tumors Resistant to Standard Therapies

Sponsor: Klus Pharma Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04152499

Provider View

This clinical trial is testing a new drug, SKB264, for patients with advanced solid tumors that cannot be removed by surgery and have not responded to standard treatments. The study aims to determine the safety and effectiveness of this new treatment.

Patient Parameters

Program Overview

This study is exploring a new treatment called SKB264 for patients with advanced solid tumors that have not responded to standard therapies. The trial is divided into two phases. In Phase I, the focus is on determining the safety of the drug, while Phase II will assess its effectiveness. Patients will receive the drug through an IV infusion, and treatment will continue until the cancer progresses or side effects become unacceptable. The study includes various types of cancer, such as breast, ovarian, lung, and others.

Description

This clinical trial is testing a new drug, SKB264, for patients with advanced solid tumors that cannot be removed by surgery and have not responded to standard treatments. The study is divided into two phases. In Phase I, the focus is on determining the safety of the drug, while Phase II will assess its effectiveness. Patients will receive the drug through an IV infusion, and treatment will continue until the cancer progresses or side effects become unacceptable. The study includes various types of cancer, such as breast, ovarian, lung, and others.

The trial is open to adults aged 18 to 75 with specific types of cancer that have not responded to standard treatments. Participants must have measurable disease and meet certain health criteria, including adequate blood counts and organ function. Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during the study and for several months after the last dose.

Patients will be monitored closely for side effects and their response to the treatment. The study aims to provide valuable insights into whether this new drug can offer improved outcomes for patients with advanced solid tumors.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 75 with advanced solid tumors that cannot be removed by surgery and have not responded to standard treatments.
  • Types of cancer include breast, ovarian, lung, gastric, and others.
  • Must have measurable disease by CT or MRI.
  • Adequate blood counts and organ function.
  • ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during the study and for several months after the last dose.
  • Must have recovered from any side effects of previous treatments.
  • Expected survival of at least 3 months.

Exclusion Criteria

  • Severe or uncontrolled heart disease or recent heart attack.
  • Active brain metastases or recent treatment for brain metastases.
  • Second primary cancers, except for certain non-threatening types.
  • Require supplemental oxygen for daily activities.
  • Severe eye conditions or history of severe dry eye syndrome.
  • Previous treatment with TROP2 targeted therapies.
  • Recent standard or experimental cancer therapies.
  • Major surgery within the last 4 weeks.
  • Active liver disease or history of alcoholism.
  • Positive test for HIV or uncontrolled high blood pressure or diabetes.
  • Pregnancy or breastfeeding.
  • Certain heart conditions or abnormal heart rhythms.
  • Severe lung diseases or recent blood clots requiring treatment.
  • Known allergies to components of SKB264.

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