NCT07446855 Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours
| NCT ID | NCT07446855 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | AstraZeneca |
| Condition | Solid Tumours |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2026-03-17 |
| Primary Completion | 2030-03-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 180 participants in total. It began in 2026-03-17 with a primary completion date of 2030-03-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this modular, first trial in human study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of ascending dose levels (DLs) of AZD4956 monotherapy and in combination with other anti-cancer agents in participants with advanced/metastatic solid tumours with homologous recombination repair (HRR) deficiencies.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07446855 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 130 Years, studying Solid Tumours. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07446855 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07446855 currently recruiting?
Yes, NCT07446855 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07446855 trial being conducted?
This trial is being conducted at New York, United States, Providence, United States, Houston, United States, Fairfax, United States and 11 additional locations.
Who is sponsoring the NCT07446855 clinical trial?
NCT07446855 is sponsored by AstraZeneca. The trial plans to enroll 180 participants.