Study of ART6043 for Patients with Advanced or Metastatic Solid Tumors

Sponsor: Artios Pharma Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05898399

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, ART6043, alone or combined with other medications, in treating advanced or metastatic solid tumors.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective ART6043 is when used alone or with other cancer drugs, Olaparib or Niraparib, in patients with advanced or metastatic solid tumors. Researchers will look at how the drug is processed in the body and its initial effectiveness in treating cancer.

Description

ART6043 is an oral medication being tested for its ability to treat cancers with specific genetic defects that affect DNA repair. The study has two parts:

  • Part A (Dose-Escalation Phase):

    • Part A1: Tests ART6043 alone in patients with advanced or metastatic cancer.
    • Part A2/A3: Tests ART6043 with either Olaparib or Niraparib in patients with advanced or metastatic cancer with specific genetic changes affecting DNA repair.

  • Part B (Dose-Expansion Phase):

    • Compares the effectiveness and safety of ART6043 combined with a PARP inhibitor (PARPi) against a PARPi alone in patients with HER2-negative advanced or metastatic breast cancer with a BRCA mutation. Patients should have had little to no prior treatment with a PARPi.

Patients can continue treatment as long as they benefit from it, unless the cancer progresses, they choose to stop, or they experience severe side effects.

Eligibility Criteria

Inclusion Criteria

  • Must have stopped previous cancer treatments at least 21 days before starting the study, except for certain hormonal therapies.
  • Must have recovered from any side effects of previous treatments.
  • Must be in good general health with a performance status of 0-2.
  • Must have good organ function.
  • Must use effective birth control if of childbearing potential.
  • Must have a life expectancy of at least 12 weeks.

Specific to Part A1:

  • Have advanced or metastatic cancer with specific genetic changes affecting DNA repair.

Specific to Part A2/A3:

  • Have advanced or metastatic cancer with specific genetic changes affecting DNA repair and be suitable for PARPi treatment.

Specific to Part B:

  • Have HER2-negative advanced or metastatic breast cancer with a BRCA mutation.
  • Have had no more than three prior chemotherapy treatments for advanced cancer.
  • Have had prior treatment with a taxane unless medically unsuitable.
  • Have had little to no prior treatment with a PARPi.

Exclusion Criteria

  • Pregnant patients.
  • Patients with certain blood disorders like MDS or AML.
  • Patients with lung diseases like interstitial lung disease or pneumonitis.
  • Patients with major digestive issues affecting drug absorption.
  • Patients with untreated brain metastases.
  • Patients who received a live vaccine within 30 days before the study.
  • Patients who had major surgery within 4 weeks before the study.
  • Patients with significant bleeding disorders or recent severe bleeding.
  • Patients allergic to study drug components.

Specific to Part B:

  • Patients with first-line advanced breast cancer without prior chemotherapy.
  • Patients with inflammatory breast cancer.

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