Phase I/IIa Study of AZD5335 Alone and with Other Cancer Treatments in Patients with Solid Tumors

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05797168

Provider View

This clinical trial is testing a new drug, AZD5335, to see if it is safe and effective when used alone or with other cancer treatments in patients with advanced solid tumors.

Patient Parameters

Program Overview

The study aims to find out if the experimental drug AZD5335, used by itself or with other cancer treatments, is safe and can help fight cancer in patients with advanced solid tumors. It is being conducted at multiple centers and involves different treatment modules.

Description

This study is testing a new drug called AZD5335, which is being given to patients with advanced solid tumors. The study is open-label, meaning both the researchers and participants know what treatment is being given. It is being conducted at multiple centers and involves different treatment modules. The study will look at how safe the drug is and how well it works when used alone or with other cancer treatments.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent and follow study requirements.
  • Agree to provide a tumor sample if needed.
  • Must be 18 years or older.
  • Willing to provide a previous or new tumor sample.
  • If previously treated with targeted therapies, a new biopsy is needed.
  • Good overall health with a performance status of 0 or 1.
  • Have received prior treatment for their cancer or a clinical trial is the best option.
  • Have measurable disease according to specific criteria.
  • Life expectancy of at least 12 weeks.
  • Adequate organ and bone marrow function.
  • Agree to use effective contraception during and after the study.
    • Men must use condoms and avoid sperm donation for about 7.5 months after the last dose.
    • Women must have a negative pregnancy test and use effective birth control during and after the study.

Exclusion Criteria

  • Spinal cord compression or certain brain conditions.
  • Active brain metastases unless stable and not needing high-dose steroids.
  • Recent use of certain medications without enough time before starting the study.
  • Unresolved side effects from previous treatments, except for certain conditions.
  • Active infections like tuberculosis, hepatitis B or C, or uncontrolled HIV.
  • History of lung inflammation requiring steroids or oxygen.
  • History of another cancer unless treated and inactive for at least 2 years.
  • Certain heart conditions or recent heart events.
  • Uncontrolled high blood pressure or recent stroke.
  • Severe heart disease or abnormal heart rhythms.
  • Uncontrolled illness or psychiatric conditions affecting study participation.
  • Substance abuse or other conditions increasing safety risks.
  • Recent live vaccine or planning to receive one during the study.
  • Pregnant or breastfeeding women.
  • Participation in another clinical study.
  • Known allergy to the study drug or its components.
  • Involvement in planning or conducting the study.
  • Investigator's judgment that the patient cannot comply with study procedures.

Get This Program In Your Inbox

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