Solid TumoursPhase 1/2PARTHENONNCT07446855
Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours
A Phase 1/2 study testing AZD4956 and Saruparib in people with Solid Tumours, run by AstraZeneca at 19 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Solid Tumours
- What is being tested?
- AZD4956 and Saruparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 17 Mar 2026to 29 Mar 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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-
- 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.
- Histologically or cytologically confirmed advanced ovarian, fallopian tube, or primary peritoneal cancer.
- Histologically or cytologically confirmed adenocarcinoma of the prostate and advanced/metastatic castrate resistant prostate cancer (CRPC).
- 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.
Trial locations and contacts
19 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
19 sites in 6 countries
Spain6 sites, 6 recruiting
- Recruiting
Research Site
Barcelona, 08023
- Recruiting
Research Site
Barcelona, 08036
- Not yet recruiting
Research Site
Barcelona, 8035
- Not yet recruiting
Research Site
Logroño, 26006
- Not yet recruiting
Research Site
Pozuelo de Alarcón, 28223
- Not yet recruiting
Research Site
Seville, 41013
United States4 sites, 4 recruiting
- Recruiting
Research Site
Fairfax, Virginia, 22031
- Recruiting
Research Site
Houston, Texas, 77030
- Recruiting
Research Site
New York, New York, 10065
- Recruiting
Research Site
Providence, Rhode Island, 02903
United Kingdom3 sites, 3 recruiting
- Recruiting
Research Site
Cambridge, CB2 0QQ
- Not yet recruiting
Research Site
London, SE1 9RT
- Recruiting
Research Site
Sutton, SM25PT
Australia2 sites, 2 recruiting
- Recruiting
Research Site
Melbourne, 3000
- Recruiting
Research Site
Westmead, 2145
Japan2 sites, 2 recruiting
- Recruiting
Research Site
Chūōku, 104-0045
- Recruiting
Research Site
Kashiwa, 277-8577
South Korea2 sites, 2 recruiting
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 120-752
About this study
Official title: A Modular Open-label, Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Ascending Doses of AZD4956 as Monotherapy, and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Repair Defective Solid Tumours
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.
Read the detailed description
The study consists of individual modules each evaluating the safety and tolerability of AZD4956 dosed as monotherapy, or with a specific combination partner. There are following 2 modules -
- Module 1: AZD4956 monotherapy
- Module 2: AZD4956 in combination with saruparib
Each module may further contain 2 parts-
- Part A (dose escalation/dose finding): To determine the safety, tolerability, PK, PD, and preliminary efficacy of AZD4956 as monotherapy or in combination.
- Part B (dose expansion): To further evaluate the safety and preliminary efficacy of AZD4956 in combination with other anti-cancer agents.
- Conditions
- Solid Tumours
- Being tested
- AZD4956, Saruparib
- Keywords
- Advanced/metastatic homologous recombination repair defective solid tumours, Poly (adenosine diphosphate-ribose) polymerase inhibitor (PARPi), Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4956Drug
AZD4956 will be administered orally.
SaruparibDrug
Saruparib will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Module 1 Part A: AZD4956 monotherapy (Dose escalation) | Experimental | Participants will receive AZD4956 as monotherapy at ascending dose levels. Receives: Drug: AZD4956 |
| Module 2 Part A: AZD4956 + saruparib (Dose escalation) | Experimental | Participants will receive AZD4956 at ascending dose levels in combination with saruparib. Receives: Drug: AZD4956; Drug: Saruparib |
| Module 2 Part A Optional PD backfill cohort: AZD4956 + saruparib | Experimental | Participants will receive AZD4956 in combination with saruparib. Receives: Drug: AZD4956; Drug: Saruparib |
| Module 2 Part A Optional PD backfill cohort: Saruparib monotherapy | Experimental | Participants will receive saruparib monotherapy. Receives: Drug: Saruparib |
| Module 2 Part A Optional non-PD backfill cohort: AZD4956 + saruparib | Experimental | Participants with metastatic castrate resistant prostate cancer (mCRPC) will receive AZD4956 in combination with saruparib. Receives: Drug: AZD4956; Drug: Saruparib |
| Module 2 Part B: AZD4956 + saruparib (Dose expansion) | Experimental | Participants will receive AZD4956 in combination with saruparib. Receives: Drug: AZD4956; Drug: Saruparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A and B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s).
Measured: From Screening (Day -28) to follow-up (up to 3.5 years)
Part B: Progression free survival (PFS)
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.
Measured: Up to 3.5 years
Part A - Number of participants with dose-limiting toxicities (DLTs)
To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s).
Measured: Up to 28 days
Secondary outcomes (23)
Objective response (OR)
OR is defined as if a participant achieves a best overall response (BOR) of confirmed complete response (CR) or partial response (PR), as assessed by the investigator, according to response evaluation criteria in solid tumours (RECIST) v1.1 criterion.
Measured: Up to 3.5 years
Duration of response (DoR)
DoR is defined as the time from the date of first documented OR assessed by RECIST v1.1, in the absence of progression on bone scan assessed by prostate cancer working group 3 (PCWG3), until the date of documented disease progression or death in the absence of disease progression.
Measured: Up to 3.5 years
Best Overall Response (BOR)
To assess the preliminary anti-tumour activity of AZD4956 monotherapy and in combination with anti-cancer agent(s).
Measured: Up to 3.5 years
Time to response (TTR)
TTR is defined as the time from the date of first dose of study intervention until the date of first documented OR assessed by RECIST v1.1, in the absence of progression on bone scan assessed by PCWG3, which is subsequently confirmed.
Measured: Up to 3.5 years
Disease control (DC)
DC is defined as if a participant has achieved a best OR of confirmed CR or PR or SD as BOR assessed by RECIST v1.1, in the absence of progression on bone scan assessed by PCWG3.
Measured: Up to 3.5 years
Clinical benefit rate (CBR)
CBR is defined as the percentage of advanced cancer participants who achieve CR, PR, or at least 16 weeks/24 weeks of stable disease, assessed by RECIST v1.1, in the absence of progression on bone scan assessed by PCWG3, as a result of therapy.
Measured: Up to 3.5 years
Part A: Progression free survival (PFS)
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.
Measured: Up to 3.5 years
Percentage change from baseline in tumour size
The best percentage change from baseline in target lesion (TL) tumour size is the largest decrease (or smallest increase) from baseline for a participant, using RECIST v1.1 assessments.
Measured: Up to 3.5 years
Number of participants with cancer antigen 125 (CA125) response (for ovarian cancer participants)
CA125 response is defined as if at least a 50% reduction in CA125 levels from a pre-treatment sample.
Measured: From baseline up to 3.5 years
Radiological progression free survival (rPFS) (for prostate cancer participants)
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.
Measured: Up to 3.5 years
Change from baseline in prostate specific antigen 50 (PSA50) response rate (for prostate cancer participants)
PSA50 response is defined as if a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later has been achieved.
Measured: From baseline up to 3.5 years
Change from baseline in PSA90 response rate (for prostate cancer participants)
PSA90 response is defined as if a ≥ 90% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later has been achieved.
Measured: From baseline up to 3.5 years
Change from baseline in PSA undetectable rate
Undetectable PSA is defined as a measurement of < 0.2 ng/mL.
Measured: At 3, 6 and 9 months
Time to PSA50/90 response (for prostate cancer participants)
Time to PSA50/90 response is defined as the time from the date of first dose of study intervention until the date of first documented PSA response (≥ 50%/90% decrease in PSA from baseline) that is confirmed by a second consecutive PSA assessment at least 3 weeks later.
Measured: Up to 3.5 years
Time to PSA progression (for prostate cancer participants)
Time to PSA progression is defined as the time from date of first dose of study intervention until the date of first documented PSA progression or the last PSA result in the absence of progression.
Measured: Up to 3.5 years
PSA PFS at 6 months (PSA-6)
PSA progression is defined as an increase in PSA of ≥ 25% from the nadir and an absolute increase of at least 2 ng/mL above nadir beyond 12 weeks. To assess the preliminary anti-tumour activity of AZD4956 monotherapy and in combination with anti-cancer. agent(s)
Measured: At 6 months
Area under the concentration-time curve (AUC)
To characterise the pharmacokinetics (PK) of AZD4956 when given orally as monotherapy and in combination with anti-cancer agent(s).
Measured: From date of first dose of study intervention up to 59 days after first dose
Maximum concentration (Cmax)
To characterise the pharmacokinetics (PK) of AZD4956 when given orally as monotherapy and in combination with anti-cancer agent(s).
Measured: From date of first dose of study intervention up to 59 days after first dose
Time to maximum concentration (Tmax)
To characterise the pharmacokinetics (PK) of AZD4956 when given orally as monotherapy and in combination with anti-cancer agent(s).
Measured: From date of first dose of study intervention up to 59 days after first dose
Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe(t1-t2))
To characterise the pharmacokinetics (PK) of AZD4956 when given orally as monotherapy and in combination with anti-cancer agent(s).
Measured: From date of first dose of study intervention up to 16 days after first dose
Renal clearance (CLR)
To characterise the pharmacokinetics (PK) of AZD4956 when given orally as monotherapy and in combination with anti-cancer agent(s).
Measured: From date of first dose of study intervention up to 16 days after first dose
Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae(t1-t2))
To characterise the pharmacokinetics (PK) of AZD4956 when given orally as monotherapy and in combination with anti-cancer agent(s).
Measured: From date of first dose of study intervention up to 16 days after first dose
Change in amount of KRAB-associated protein-1 phosphorylated on serine 824 [pKAP1 (Ser824)] biomarker in tumour cells at baseline and during treatment
To evaluate PD of AZD4956 in tumour cells when given orally as monotherapy and in combination with anti-cancer agent(s).
Measured: From Baseline up to 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start17 Mar 2026
- Primary completion29 Mar 2030 (estimated)
- Study completion29 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446855
- Sponsor's protocol ID
- D8570C00001
- Other IDs
- 2025-524171-22-00, 2025
- Acronym
- PARTHENON
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modular Open-label, Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Ascending Doses of AZD4956 as Monotherapy, and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Repair Defective Solid Tumours
- ClinicalTrials.gov ID
- NCT07446855
- Acronym / sponsor ID
- PARTHENON / D8570C00001
- Conditions
- Solid Tumours
- Keywords
- Advanced/metastatic homologous recombination repair defective solid tumours, Poly (adenosine diphosphate-ribose) polymerase inhibitor (PARPi), Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 29 Mar 2030 (estimated)
- Study completion
- 29 Mar 2030 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study consists of individual modules each evaluating the safety and tolerability of AZD4956 dosed as monotherapy, or with a specific combination partner. There are following 2 modules -
- Module 1: AZD4956 monotherapy
- Module 2: AZD4956 in combination with saruparib
Each module may further contain 2 parts-
- Part A (dose escalation/dose finding): To determine the safety, tolerability, PK, PD, and preliminary efficacy of AZD4956 as monotherapy or in combination.
- Part B (dose expansion): To further evaluate the safety and preliminary efficacy of AZD4956 in combination with other anti-cancer agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Module 1 Part A: AZD4956 monotherapy (Dose escalation) | Experimental | Drug: AZD4956Participants will receive AZD4956 as monotherapy at ascending dose levels. |
| Module 2 Part A: AZD4956 + saruparib (Dose escalation) | Experimental | Drug: AZD4956, Drug: SaruparibParticipants will receive AZD4956 at ascending dose levels in combination with saruparib. |
| Module 2 Part A Optional PD backfill cohort: AZD4956 + saruparib | Experimental | Drug: AZD4956, Drug: SaruparibParticipants will receive AZD4956 in combination with saruparib. |
| Module 2 Part A Optional PD backfill cohort: Saruparib monotherapy | Experimental | Drug: SaruparibParticipants will receive saruparib monotherapy. |
| Module 2 Part A Optional non-PD backfill cohort: AZD4956 + saruparib | Experimental | Drug: AZD4956, Drug: SaruparibParticipants with metastatic castrate resistant prostate cancer (mCRPC) will receive AZD4956 in combination with saruparib. |
| Module 2 Part B: AZD4956 + saruparib (Dose expansion) | Experimental | Drug: AZD4956, Drug: SaruparibParticipants will receive AZD4956 in combination with saruparib. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD4956AZD4956 will be administered orally. | Drug | Module 1 Part A: AZD4956 monotherapy (Dose escalation), Module 2 Part A Optional PD backfill cohort: AZD4956 + saruparib, Module 2 Part A Optional non-PD backfill cohort: AZD4956 + saruparib, Module 2 Part A: AZD4956 + saruparib (Dose escalation), Module 2 Part B: AZD4956 + saruparib (Dose expansion) |
| SaruparibSaruparib will be administered orally. | Drug | Module 2 Part A Optional PD backfill cohort: AZD4956 + saruparib, Module 2 Part A Optional PD backfill cohort: Saruparib monotherapy, Module 2 Part A Optional non-PD backfill cohort: AZD4956 + saruparib, Module 2 Part A: AZD4956 + saruparib (Dose escalation), Module 2 Part B: AZD4956 + saruparib (Dose expansion) |
Primary outcome
Parts A and B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: 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)
Time frame: 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)
Time frame: Up to 28 days
To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s).
23 secondary outcomes
Objective response (OR)
Time frame: Up to 3.5 years
Duration of response (DoR)
Time frame: Up to 3.5 years
Best Overall Response (BOR)
Time frame: Up to 3.5 years
Time to response (TTR)
Time frame: Up to 3.5 years
Disease control (DC)
Time frame: Up to 3.5 years
Clinical benefit rate (CBR)
Time frame: Up to 3.5 years
Part A: Progression free survival (PFS)
Time frame: Up to 3.5 years
Percentage change from baseline in tumour size
Time frame: Up to 3.5 years
Number of participants with cancer antigen 125 (CA125) response (for ovarian cancer participants)
Time frame: From baseline up to 3.5 years
Radiological progression free survival (rPFS) (for prostate cancer participants)
Time frame: Up to 3.5 years
Change from baseline in prostate specific antigen 50 (PSA50) response rate (for prostate cancer participants)
Time frame: From baseline up to 3.5 years
Change from baseline in PSA90 response rate (for prostate cancer participants)
Time frame: From baseline up to 3.5 years
Change from baseline in PSA undetectable rate
Time frame: At 3, 6 and 9 months
Time to PSA50/90 response (for prostate cancer participants)
Time frame: Up to 3.5 years
Time to PSA progression (for prostate cancer participants)
Time frame: Up to 3.5 years
PSA PFS at 6 months (PSA-6)
Time frame: At 6 months
Area under the concentration-time curve (AUC)
Time frame: From date of first dose of study intervention up to 59 days after first dose
Maximum concentration (Cmax)
Time frame: From date of first dose of study intervention up to 59 days after first dose
Time to maximum concentration (Tmax)
Time frame: From date of first dose of study intervention up to 59 days after first dose
Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe(t1-t2))
Time frame: From date of first dose of study intervention up to 16 days after first dose
Renal clearance (CLR)
Time frame: From date of first dose of study intervention up to 16 days after first dose
Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae(t1-t2))
Time frame: From date of first dose of study intervention up to 16 days after first dose
Change in amount of KRAB-associated protein-1 phosphorylated on serine 824 [pKAP1 (Ser824)] biomarker in tumour cells at baseline and during treatment
Time frame: From Baseline up to 3.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD4956 and Saruparib in people with Solid Tumours, run by AstraZeneca at 19 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain, United States, United Kingdom, Australia, Japan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts A and B: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: From Screening (Day -28) to follow-up (up to 3.5 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.