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Study of AZD4956 for Advanced Solid Tumors

This study is testing a new medication called AZD4956, both by itself and in combination with another anti-cancer drug called Saruparib. We are looking for people with advanced or metastatic (spread to other parts of the body) solid tumors that have specific genetic changes called homologous recombination repair (HRR) deficiencies. The main goals are to understand how safe AZD4956 is, what side effects it might cause, and if it helps to slow down or stop cancer growth. We will be looking at how long people live without their cancer getting worse. You may be able to join if you are at least 18 years old, have a solid tumor that has spread, and are generally well enough to participate.

Study design
This study is designed in modules, with some parts testing AZD4956 alone and others testing it with Saruparib. It will involve up to 180 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and serious adverse events for up to 3.5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07446855

Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~180 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:AZD4956Saruparib

At a glance

Recruiting sites
5 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts A and B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured over From Screening (Day -28) to follow-up (up to 3.5 years)
+2 more outcomes measured

Conditions

Solid Tumours

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Where it's being run

19 sites across 9 states
Spain6
United Kingdom3
Australia2
Japan2
South Korea2
New York1
Rhode Island1
Texas1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Eligibility criteria

Inclusion

Documented locally advanced or metastatic solid tumour malignancy.
Eastern cooperative oncology group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to screening and first day of dosing.
Minimum life expectancy ≥ 12 weeks.
Adequate organ and marrow function.
Female participants must not breastfeed and must not donate or retrieve ova for their own use from screening to approximately 6 months after the last dose of study intervention.
Demonstrated evidence of disease progression.
Participants must have advanced or metastatic solid tumours.
Participants may have received up to one prior line of therapy with a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARPi)-based regimen (either as a treatment or as maintenance).
Participants must have one of the following conditions-
Participants must have evaluable disease.
Participants in PD backfill cohorts must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).
Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate and advanced/metastatic CRPC.
Participants must have documented metastatic disease by clear evidence of ≥ 1 bone lesion (defined as one lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable or non-measurable).
Participants must have received the prior approved systemic therapies for metastatic prostate cancer.
Participants must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).

Exclusion

Any significant laboratory finding or any severe and uncontrolled medical condition.
Participants with any known predisposition to bleeding.
Spinal cord compression or symptomatic and unstable brain metastases or leptomeningeal disease.
Allogenic organ transplantation.
Known to have active infection, including hepatitis B virus (HBV) or hepatitis C virus (HCV).
Known history of infection with human immunodeficiency virus (HIV).
Active gastrointestinal disease or other condition that will interfere significantly with the swallowing, absorption, distribution, metabolism or excretion of oral therapy.
Participants with history of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML.
Participants with a known hypersensitivity to the investigational product(s) or any of the excipients of the product(s).
Previous dosing with AZD4956.

What this trial measures

  • Parts A and B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)From Screening (Day -28) to follow-up (up to 3.5 years)

    To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s).

  • Part B: Progression free survival (PFS)Up to 3.5 years

    PFS is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participants withdraw from study treatment or receive another anti-cancer therapy prior to progression.

  • Part A - Number of participants with dose-limiting toxicities (DLTs)Up to 28 days

    To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s).