Study on AZD4956 Alone and with Other Cancer Drugs for Advanced Solid Tumors with HRR Deficiencies

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07446855

This clinical trial is testing the safety and effectiveness of a new drug, AZD4956, both on its own and combined with other cancer treatments, in patients with advanced solid tumors that have specific genetic repair deficiencies.

Patient Parameters

Parameter	Options

Program Overview

The aim of this study is to evaluate the safety, tolerability, and initial effectiveness of AZD4956, a new drug, when used alone or with other cancer treatments in patients with advanced solid tumors that have homologous recombination repair (HRR) deficiencies. The study will explore different doses to find the most effective and safe levels for treatment.

Description

The study is divided into different parts, each focusing on the safety and tolerability of AZD4956, either alone or with another drug. There are two main modules:

Module 1: Testing AZD4956 by itself.
Module 2: Testing AZD4956 with another drug called saruparib.

Each module has two parts:

Part A: This part is about finding the right dose and checking the safety and initial effectiveness of AZD4956, either alone or in combination.
Part B: This part further examines the safety and effectiveness of AZD4956 when combined with other cancer drugs.

Eligibility Criteria

Inclusion Criteria

Have a confirmed diagnosis of advanced or metastatic solid tumor.
Be in good general health with a performance status score 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.
Female participants must not breastfeed and must avoid pregnancy during the study and for six months after.

Module 1 Specifics:

Show evidence of disease progression.
Have advanced or metastatic solid tumors.
May have had one previous treatment with a specific type of cancer drug (PARPi).

Module 2 Specifics:

Have specific types of cancer, such as advanced breast, ovarian, prostate, or pancreatic cancer.
Have measurable disease.
For certain groups, must not have had previous treatment with PARPi drugs.
Must have a tumor that can be biopsied for certain groups.
Must have advanced prostate cancer with evidence of spread to bones or soft tissue.
Must have had previous approved treatments for metastatic prostate cancer.

Exclusion Criteria

Have any severe or uncontrolled medical conditions.
Have a tendency to bleed easily.
Have spinal cord compression or unstable brain metastases.
Have had an organ transplant.
Have active infections like hepatitis B, hepatitis C, or HIV.
Have digestive issues that affect the absorption of oral medications.
Have a history of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
Have allergies to the study drug or its ingredients.
Have previously taken AZD4956.

Locations

FACILITY	ZIP	CITY	STATE
Research Site	10065	New York	New York
Research Site	02903	Providence	Rhode Island
Research Site	77030	Houston	Texas
Research Site	22031	Fairfax	Virginia

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