Actively Recruiting
Study of AZD4956 Alone and With Anti-Cancer Agents in Advanced or Metastatic Homologous Recombination Deficient Solid Tumors
Led by AstraZeneca · Updated on 2026-05-26
180
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD4956, both alone and combined with other anti-cancer drugs, in people with advanced or metastatic solid tumors that have homologous recombination repair (HRR) defects. This first human trial aims to study the safety, tolerability, how the drug is processed in the body, its biological effects, and preliminary signs of effectiveness. The study is divided into two main modules: Module 1 tests AZD4956 by itself, and Module 2 tests AZD4956 combined with saruparib. Each module has two parts: Part A focuses on finding safe dose levels and assessing drug effects, while Part B expands the study to further evaluate safety and preliminary effectiveness. Participants receive AZD4956 orally, either alone or with saruparib, with some receiving saruparib alone. Different groups include those with specific cancers, such as metastatic castrate resistant prostate cancer. Participants will be monitored from screening through follow-up periods lasting up to 3.5 years. Researchers will track adverse events, dose-limiting toxicities, progression-free survival, tumor response, and changes in cancer markers. Throughout the trial, participants undergo regular assessments including laboratory tests, imaging, and biomarker analysis. Safety and treatment effects will be closely observed to understand how AZD4956 works alone and with other treatments.
CONDITIONS
Brief Title
Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented locally advanced or metastatic solid tumor malignancy.
- ECOG performance status of 0 or 1 with no recent deterioration.
- Life expectancy of at least 12 weeks.
- Adequate organ and marrow function.
- Female participants must not breastfeed and must avoid donating or retrieving ova from screening to 6 months after last dose.
- Evidence of disease progression (Module 1).
- Advanced or metastatic solid tumors (Module 1).
- Up to one prior line of therapy with a PARP inhibitor regimen allowed (Module 1).
- Histologically or cytologically confirmed breast, ovarian, fallopian tube, primary peritoneal, prostate, or pancreatic cancer with specific genetic mutations (Module 2 Part A).
- Evaluable disease (Module 2 Part A).
- No prior PARP inhibitor therapy for PD backfill cohorts (Module 2 Part A).
- Tumor suitable for biopsy for participants undergoing paired biopsies (Module 2 Part A PD backfill).
- Histologically or cytologically confirmed adenocarcinoma of prostate with metastatic disease (Module 2 Part A Non-PD and Part B).
- Prior approved systemic therapies for metastatic prostate cancer received (Module 2 Part A Non-PD and Part B).
- No prior PARP inhibitor therapy (Module 2 Part A Non-PD and Part B).
You will not qualify if you...
- Any significant laboratory abnormality or severe uncontrolled medical condition.
- Known bleeding predisposition.
- Spinal cord compression or symptomatic, unstable brain metastases or leptomeningeal disease.
- History of allogenic organ transplantation.
- Active infection including hepatitis B, hepatitis C, or HIV.
- Active gastrointestinal disease interfering with oral drug absorption or metabolism.
- History or features of myelodysplastic syndrome or acute myeloid leukemia.
- Known hypersensitivity to study drugs or their ingredients.
- Previous treatment with AZD4956.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3.5 years or until disease progression or discontinuation
Participants receive AZD4956 as monotherapy or in combination with saruparib, with dose escalation and dose expansion parts depending on the module. Treatment includes evaluation of safety, tolerability, and preliminary efficacy.
Repeated visits according to dosing cycles for up to 3.5 years
Duration - Up to 3.5 years
Participants are monitored for adverse events and treatment outcomes after completing treatment.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 18 locations
1
Research Site
New York, New York, United States, 10065
Not Yet Recruiting
2
Research Site
Providence, Rhode Island, United States, 02903
Not Yet Recruiting
3
Research Site
Houston, Texas, United States, 77030
Not Yet Recruiting
4
Research Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
5
Research Site
Melbourne, Australia, 3000
Not Yet Recruiting
6
Research Site
Westmead, Australia, 2145
Not Yet Recruiting
7
Research Site
Chūōku, Japan, 104-0045
Not Yet Recruiting
8
Research Site
Kashiwa, Japan, 277-8577
Not Yet Recruiting
9
Research Site
Seoul, South Korea, 03080
Not Yet Recruiting
10
Research Site
Seoul, South Korea, 120-752
Not Yet Recruiting
11
Research Site
Barcelona, Spain, 08023
Not Yet Recruiting
12
Research Site
Barcelona, Spain, 08036
Not Yet Recruiting
13
Research Site
Barcelona, Spain, 8035
Not Yet Recruiting
14
Research Site
Logroño, Spain, 26006
Not Yet Recruiting
15
Research Site
Pozuelo de Alarcón, Spain, 28223
Not Yet Recruiting
16
Research Site
Seville, Spain, 41013
Not Yet Recruiting
17
Research Site
London, United Kingdom, SE1 9RT
Not Yet Recruiting
18
Research Site
Sutton, United Kingdom, SM25PT
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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