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New drug combo targets Hard-to-Treat cancers in early trial

NCT ID NCT07446855

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 6 times

Summary

This study tests a new drug called AZD4956, alone or with other cancer drugs, in people with advanced or spreading solid tumors that have a specific DNA repair defect (HRR deficiency). The main goals are to check safety, find the best dose, and see if the drug can shrink tumors. About 180 adults with few other options will take part in this early-phase trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Core Inclusion Criteria: * 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. Module 1 Inclusion Criteria: * 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). Module 2 Inclusion Criteria: Part A (AZD4956 in Combination with Saruparib Dose Escalation) and Part A-PD (PD Backfill Cohorts): * Participants must have one of the following conditions- 1. Histologically or cytologically confirmed carcinoma of the breast with recurrent locally advanced or metastatic disease and evidence of a predicted loss of function germline or somatic mutation. 2. Histologically or cytologically confirmed advanced ovarian, fallopian tube, or primary peritoneal cancer. 3. Histologically or cytologically confirmed adenocarcinoma of the prostate and advanced/metastatic castrate resistant prostate cancer (CRPC). 4. Histologically or cytologically confirmed advanced/metastatic pancreatic cancer. * 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). Part A (PD Backfill Cohorts) - Participants Undergoing Paired Biopsies: \- Participants must have a tumour suitable for biopsy. Part A-Non-PD (Non-PD Backfill Cohorts) and Part B (Dose Expansion Cohorts): * 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). Core Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

breast cancer castration-resistant prostate carcinoma DNA repair disease fallopian tube cancer malignant pancreatic neoplasm ovarian cancer primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumours

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    New York, New York, 10065, United States

  • Research Site

    NOT_YET_RECRUITING

    Providence, Rhode Island, 02903, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Research Site

    RECRUITING

    Melbourne, 3000, Australia

  • Research Site

    NOT_YET_RECRUITING

    Westmead, 2145, Australia

  • Research Site

    NOT_YET_RECRUITING

    Chūōku, 104-0045, Japan

  • Research Site

    RECRUITING

    Kashiwa, 277-8577, Japan

  • Research Site

    NOT_YET_RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Seoul, 120-752, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Barcelona, 08023, Spain

  • Research Site

    NOT_YET_RECRUITING

    Barcelona, 08036, Spain

  • Research Site

    NOT_YET_RECRUITING

    Barcelona, 8035, Spain

  • Research Site

    NOT_YET_RECRUITING

    Logroño, 26006, Spain

  • Research Site

    NOT_YET_RECRUITING

    Pozuelo de Alarcón, 28223, Spain

  • Research Site

    NOT_YET_RECRUITING

    Seville, 41013, Spain

  • Research Site

    NOT_YET_RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    London, SE1 9RT, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Sutton, SM25PT, United Kingdom

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