Study on IMP4297 and Temozolomide for Patients with Advanced Solid Tumors and Small Cell Lung Cancer

Sponsor: Impact Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04434482

Provider View

This clinical trial is testing a new combination of drugs, IMP4297 and temozolomide, to see if they are safe and effective in treating advanced solid tumors and small cell lung cancer that has progressed after initial treatment.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new drug combination, IMP4297 and temozolomide, in patients with advanced solid tumors and small cell lung cancer (SCLC) that has worsened after first-line platinum-based treatment. The trial will be conducted in two parts: the first part will determine the best dose, and the second part will further assess the treatment's effectiveness in two groups of SCLC patients.

Description

This clinical trial is divided into two parts. In the first part, researchers will test different doses of the drug combination IMP4297 and temozolomide to find the safest and most effective dose for future studies. In the second part, the study will focus on two groups of patients with small cell lung cancer (SCLC) that has either responded well or poorly to previous platinum-based chemotherapy. The goal is to see how well the drug combination works in shrinking tumors and to monitor any side effects.

Participants will be closely monitored throughout the study to ensure their safety and to evaluate the treatment's impact on their cancer. The study will involve regular health checks, imaging scans, and laboratory tests to track the progress of the disease and any potential side effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to participate and able to provide written consent.
  • Aged 18 years or older.
  • For Part I: Have an advanced solid tumor that has not responded to standard treatments, including cancers like triple-negative breast cancer, small cell lung cancer, ovarian cancer, and metastatic prostate cancer.
  • For Part II: Have small cell lung cancer that has progressed after one course of platinum-based chemotherapy.
  • Have a performance status indicating good overall health (ECOG score of 0-1 for Part I, 0-2 for Part II).
  • Have a life expectancy of at least 12 weeks.
  • For Part II: Have at least one measurable tumor that can be tracked during the study.
  • Have adequate organ function as shown by specific lab tests.
  • Female participants must not be pregnant or breastfeeding and must agree to use effective contraception.
  • Male participants must agree to use effective contraception.

Exclusion Criteria

  • Have active or untreated brain cancer or cancer that has spread to the brain.
  • Have serious infections or a history of certain viral infections like HIV, hepatitis B, or hepatitis C.
  • Have previously been treated with PARP inhibitors.
  • Have taken certain medications that affect the liver or immune system recently.
  • Have received a live vaccine within 28 days before starting the study.
  • Have not fully recovered from previous cancer treatments.
  • Have had major surgery or radiation therapy recently.
  • Have other cancers within the last two years, except for certain non-threatening types.
  • Have uncontrolled fluid buildup in the body.
  • Have a history of seizures or certain blood disorders.
  • Have serious heart conditions or recent heart attacks.
  • Have difficulty swallowing pills or have digestive issues affecting medication absorption.
  • Have allergies to the study drugs.
  • Have a history of substance abuse.
  • Have any condition that the study doctor believes could put the patient at risk.

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