Study on the Safety of AZD6750 for Adults with Advanced or Metastatic Solid Tumors

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07115043

Provider View

This clinical trial is testing the safety of a new drug, AZD6750, in adults with certain advanced or metastatic solid tumors. The study will also explore how the drug works in the body and its effectiveness, both alone and in combination with other cancer treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effects of AZD6750, a new drug designed to help the immune system fight cancer, in adults with advanced or metastatic solid tumors. Researchers will look at how the drug is processed in the body, its impact on the immune system, and its ability to shrink tumors. The study will include participants with various types of cancer, and some will receive AZD6750 alone, while others will receive it in combination with other cancer treatments.

Description

This study is divided into two phases: Phase I and Phase II. In Phase I, researchers will determine the safest dose of AZD6750 and observe how it affects the body. In Phase II, they will further explore the drug's effectiveness in treating advanced or metastatic solid tumors. Participants will include adults with specific types of cancer, such as melanoma, squamous cell carcinoma, and non-small cell lung cancer, among others. The study will involve regular health checks, blood tests, and imaging scans to monitor the participants' response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Able to provide a previous tumor sample for analysis.
  • Have at least one measurable tumor that can be tracked using standard criteria.
  • Expected to live at least 12 more weeks.
  • Have stable heart function and good bone marrow, liver, and kidney function.
  • Weigh at least 35 kg (about 77 pounds).
  • Able to understand and sign a consent form.

Module 1 specific criteria:

  • Have locally advanced or metastatic solid tumors, such as melanoma, squamous cell carcinoma, or non-small cell lung cancer, and have received standard treatment.

Module 2 specific criteria:

  • Have Stage IV non-small cell lung cancer (NSCLC) and have received at least one prior treatment in the metastatic setting, or have not received systemic therapy and have a PD-L1 expression of 1% or higher.

Exclusion Criteria

  • Have severe or uncontrolled diseases affecting the lungs, heart, or related to tumors.
  • Have had or plan to have an organ or stem cell transplant.
  • Have active or recent autoimmune or inflammatory disorders.
  • Have had severe side effects from previous immunotherapy.
  • Have ongoing side effects from previous cancer treatments.
  • Have untreated or unstable brain metastases.
  • Have untreated or symptomatic spinal cord compression or a history of cancer in the brain lining.
  • Have active hepatitis B or C infections.
  • Have a history of severe lung inflammation not caused by infection.
  • Require long-term use of immune-suppressing medications.
  • Have received a live vaccine within the last 30 days.

Module 2 specific criteria:

  • Have previously been treated with anti-TIGIT therapy.
  • Have genetic changes in NSCLC that have a targeted therapy available as the first treatment.

Locations

FACILITYZIPCITYSTATE
Research Site49546Grand RapidsMichigan
Research Site63110St LouisMissouri
Research Site15232PittsburghPennsylvania
Research Site77030HoustonTexas
Research Site78229San AntonioTexas
Research Site22031FairfaxVirginia

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