Chiauranib for Advanced Solid Tumors and Relapsed/Refractory Small Cell Lung Cancer

Sponsor: Chipscreen Biosciences, Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05271292

Provider View

This clinical trial is testing a new drug, Chiauranib, to see if it is safe and effective for treating advanced solid tumors and small cell lung cancer (SCLC) that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is divided into two parts. In the first part, different doses of Chiauranib will be tested to find the safest and most effective dose. In the second part, this dose will be given to patients with SCLC that has progressed after at least two previous treatments, including one with platinum-based chemotherapy. Patients will take Chiauranib daily in 28-day cycles without breaks between cycles.

Description

In the first phase of the study, patients with various advanced cancers, including small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, liver cancer, ovarian cancer, neuroendocrine tumors, and non-Hodgkin's lymphoma, will receive different doses of Chiauranib. The doses will start at 35 mg and may increase to 50 mg and 65 mg, depending on safety results. Each patient will first take a single dose and then continue with daily doses for 28 days. The safety of these doses will be closely monitored.

In the second phase, patients with SCLC that has worsened after at least two previous treatments will receive the recommended dose of Chiauranib daily in 28-day cycles. The goal is to see if this treatment can help control the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of an advanced solid tumor, such as SCLC, NSCLC, colorectal cancer, pancreatic cancer, liver cancer, ovarian cancer, neuroendocrine tumors, or non-Hodgkin's lymphoma, that has returned or not responded to standard treatments.
  • Have at least one measurable tumor that shows disease progression after previous treatments.
  • 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 normal blood counts and organ function based on specific lab tests.
  • Have a life expectancy of at least 3 months.
  • Be able to provide informed consent.
  • Women of childbearing potential must agree to use effective contraception during the study and for 12 weeks after the last dose.
  • Men must agree to use condoms and ensure their female partners use effective contraception during the study and for 12 weeks after the last dose.

Exclusion Criteria

  • Have received any cancer treatment within 21 days before starting the study or blood support therapy within 2 weeks before starting.
  • Have other cancers that could interfere with the study.
  • Have uncontrolled heart disease or significant heart problems.
  • Have high blood pressure that is not well controlled.
  • Have active bleeding or a high risk of bleeding.
  • Have uncontrolled fluid buildup in the body.
  • Have active or untreated brain metastases.
  • Have a history of serious blood clots within 6 months before starting the study.
  • Have lung diseases that require treatment.
  • Have significant side effects from previous cancer treatments.
  • Have gastrointestinal issues that affect drug absorption.
  • Have had major surgery within 6 weeks or minor surgery within 2 weeks before starting the study.
  • Have significant protein in the urine.
  • Have active infections like hepatitis B, hepatitis C, or HIV/AIDS.
  • Have mental or cognitive impairments that affect understanding the study.
  • Have had severe side effects from similar drugs in the past.
  • Have drug or alcohol abuse issues.
  • Are pregnant, planning to become pregnant, or breastfeeding.
  • Are taking certain medications that affect how the body processes drugs.
  • Have any other conditions that make participation inappropriate.

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