Actively Recruiting
Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours
Led by AstraZeneca · Updated on 2026-04-20
180
Participants Needed
18
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 not donate or retrieve 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 PARP inhibitor therapy allowed (Module 1)
- For Module 2 Part A and PD backfill cohorts, diagnosed with specific cancers including breast, ovarian, prostate, or pancreatic cancer with required mutations
- Must have evaluable disease (Module 2 Part A)
- PD backfill cohorts must not have received prior PARP inhibitor therapy
- Tumor suitable for biopsy if undergoing paired biopsies (Part A PD backfill cohorts)
- For Part A Non-PD and Part B, diagnosis of adenocarcinoma of prostate with advanced/metastatic castrate resistant prostate cancer
- Documented metastatic disease with at least one bone or soft tissue lesion (Part A Non-PD and Part B)
- Must have received prior approved systemic therapies for metastatic prostate cancer (Part A Non-PD and Part B)
- Must not have received prior PARP inhibitor therapy (Part A Non-PD and Part B)
You will not qualify if you...
- Any significant lab 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
- Known active infection including hepatitis B, hepatitis C, or HIV
- Active gastrointestinal disease or condition interfering with oral therapy
- History or features of myelodysplastic syndrome or acute myeloid leukemia
- Known allergy 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
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
CONTACT
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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