Study on AZD8205 Alone or with Other Cancer Drugs for Advanced or Metastatic Solid Tumors

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT05123482

This clinical trial is testing a new drug, AZD8205, to see if it can help treat advanced or metastatic solid tumors, either by itself or combined with other cancer treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new drug called AZD8205 as a potential treatment for advanced or metastatic solid tumors. Researchers are testing AZD8205 both on its own and in combination with other cancer drugs to see how well it works and how safe it is for patients.

Description

This study is a Phase I/IIa trial conducted at multiple centers. It is an open-label study, meaning both the researchers and participants know what treatment is being given. The study involves testing AZD8205 alone and in combination with other cancer drugs in patients with advanced solid tumors. The trial aims to find the best dose and assess the safety and effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced or metastatic solid tumors that have been treated with standard therapies, or if a clinical trial is considered the best option by the doctor.
  • Have measurable disease according to specific medical criteria.
  • 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 a life expectancy of at least 12 weeks.
  • Have adequate organ and bone marrow function as defined in the study.

For Sub-Study 1 Part A:

  • Have confirmed metastatic or locally advanced/recurrent breast, ovarian, biliary tract, or endometrial cancer.

For Sub-Study 1 Part B:

  • Have confirmed metastatic or locally advanced and recurrent disease for specific cancer types:
    • Biliary Tract Cancer
    • Ovarian Cancer
    • Breast Cancer
    • Endometrial Cancer

For Sub-Study 2 Part A:

  • Weigh at least 30 kg.
  • Have confirmed metastatic or locally advanced/recurrent breast, ovarian, biliary tract, or endometrial cancer.

Exclusion Criteria

  • Have received certain cancer treatments within specific time frames before starting the study:
    • Nitrosourea or mitomycin C within 6 weeks.
    • Investigational drugs from a previous study within 5 half-lives or 28 days.
    • Other anticancer treatments within 21 days for cytotoxic drugs, 21 days or 5 half-lives for non-cytotoxic drugs, and 28 days for biological products.
  • Have spinal cord compression or a history of cancer spread to the brain lining.
  • Have untreated or unstable brain metastases.
  • Have active infections like tuberculosis, hepatitis B or C, or HIV.
  • Have a history of lung inflammation requiring steroids or current lung issues.
  • Have severe lung problems from other illnesses.
  • Have certain heart conditions, such as uncontrolled arrhythmias, recent heart attacks, or severe heart disease.
  • Have a history of stroke or brain blood flow issues in the last 6 months.
  • Have a prolonged QT interval on an ECG.
  • Have risk factors for heart rhythm problems.

Additional Exclusion Criteria for Part A Sub-Study 2:

  • Have had a blood clot within 3 months before starting the study.
  • Have had severe side effects from previous immunotherapy.
  • Have active or past autoimmune or inflammatory disorders requiring long-term steroid or immunosuppressive treatment.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.