Study on ART0380 for Treating Advanced or Metastatic Solid Tumors

Sponsor: Artios Pharma Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04657068

Provider View

This clinical trial is testing a new drug called ART0380 to see if it is safe and effective for people with advanced or metastatic solid tumors. The study will also explore how ART0380 works alone and when combined with other cancer drugs, gemcitabine or irinotecan.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new cancer treatment called ART0380, which is being tested for its safety and effectiveness in people with advanced or metastatic solid tumors. ART0380 is designed to target cancers with specific DNA repair issues. The study will test ART0380 alone and in combination with other cancer drugs, gemcitabine or irinotecan, to find the best dose and understand potential side effects.

Description

ART0380 is a new oral cancer drug that targets specific DNA repair problems in cancer cells. This study is in its early stages (Phase I/IIa) and aims to assess the safety, tolerability, and initial effectiveness of ART0380, either by itself or combined with gemcitabine or irinotecan, in patients with advanced or metastatic solid tumors. The study will include patients with certain types of cancer, such as high-grade serous ovarian cancer, and those whose tumors do not express a specific protein (ATM). Participants will receive ART0380 and undergo regular health checks to monitor their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Have not previously received treatment targeting the ATR/CHK1 pathway.
  • Must have stopped all previous cancer treatments for at least 21 days and recovered from any side effects.
  • If applicable, must have tried approved treatments for BRCA mutations before joining the study.
  • Must have at least one tumor that can be measured by scans.
  • Must have acceptable blood, kidney, liver, and clotting function.
  • Must provide a tumor sample for analysis.
  • Women and men of childbearing potential must use effective birth control during the study and for several months after.
  • Must have an estimated life expectancy of at least 12 weeks.
  • Must be willing to follow study procedures and attend all appointments.

Additional criteria for specific parts of the study:

  • Part A1: Advanced cancer that is resistant to standard treatments or has no standard treatments available.
  • Part A2: Advanced cancer where gemcitabine is suitable.
  • Part A3: Advanced cancer where irinotecan is suitable.
  • Part B1: Advanced cancer with ATM gene changes.
  • Part B2: High-grade serous ovarian cancer with BRCA mutations or HRD positive.
  • Part B3: Persistent or recurrent endometrial cancer.
  • Part B4: Advanced cancer with specific biological markers.
  • Part B5: Metastatic colorectal cancer with ATM gene changes.

Exclusion Criteria

  • Women who are pregnant or breastfeeding, or plan to become pregnant during or shortly after the study.
  • Men planning to father a child during or shortly after the study.
  • Serious health conditions that could interfere with the study.
  • Ongoing lung disease or heart problems.
  • Uncontrolled brain or spinal cord cancer spread.
  • Recent live vaccine or major surgery.
  • Significant bleeding disorders.
  • Currently in another clinical trial.

Additional criteria for specific parts of the study:

  • Part A3 and B1 with irinotecan: Specific genetic conditions affecting drug metabolism.

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