Locally Advanced or Metastatic Solid TumorPhase 1AZD5305NCT06713369
AZD5305 hADME in Patients With Advanced Solid Malignancies
A Phase 1 study testing Saruparib (AZD5305), [14C]-AZD5305 microtracer and [14C]-AZD5305 (therapeutic dose) in people with Locally Advanced or Metastatic Solid Tumor, run by AstraZeneca at 2 sites in United Kingdom.
Trial summary
This Phase I, open-label study aims to study to absolute bioavailability of Saruparib (AZD5305) and the absorption, distribution, metabolism and excretion (ADME) of [14C]-Saruparib in patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumor
- What is being tested?
- Saruparib (AZD5305), [14C]-AZD5305 microtracer and [14C]-AZD5305 (therapeutic dose)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 2 Apr 2025to 2 Oct 2026
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the ICF.
- Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable.
- ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to dosing.
- Predicted life expectancy ≥ 12 weeks.
- Adequate organ and marrow function as defined in the protocol
- Willingness and ability to comply with study and follow-up procedures.
Show all 11Show fewer
- Able and willing to stay in hospital for specified residential periods following administration of Saruparib/[14C]-Saruparib
- Regular bowel movements
- Body weight within normal range specified in protocol
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Reproduction
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
Who cannot join
- Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). Specific screening for MDS/AML is not required.
- Participants with any known predisposition to bleeding
- Any history of persisting severe cytopenia due to any cause
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of Saruparib.
- History of another primary malignancy, with some exceptions
- Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy.
Show all 29Show fewer
- Spinal cord compression or brain metastases for at least 4 weeks prior to start of study intervention unless asymptomatic and stable
- Abnormal cardiac function exclusions or cardiovascular disease
- History of arrhythmia
- Active HBV (positive HBsAg result) or HCV.
- Evidence of active and uncontrolled HIV infection.
- Active tuberculosis infection
- Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
- As judged by the investigator, any other evidence of diseases (such as severe or uncontrolled systemic diseases or active uncontrolled infections which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or would jeopardise compliance with the protocol.
- Any prior treatment with a PARP inhibitor or platinum chemotherapy.
- Other anticancer therapy (chemotherapy, immunotherapy, hormonal anticancer therapy, radiotherapy [except for palliative local radiotherapy]), biological therapy or other novel agent is not permitted until the last PK sampling is completed.
- Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study intervention
- Concomitant use of medications or herbal supplements known to be CYP3A4 strong and moderate inhibitors or inducers
- Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes
- Participants who have participated in another absorption, distribution, metabolism, and excretion study within 1 year prior to screening.
- Participation in another clinical study with a study intervention administered in the last 3 months or 5 half-lives prior to dosing, whichever is longer.
- Participants with a known hypersensitivity to Saruparib or any of the excipients of the product.
- Participants who have been administered any amount of a [14C]-labelled compound within the last 12 months.
- Use of tobacco- or nicotine-containing products or alcohol may be exclusionary
- Poor peripheral venous access (venous access via a port will be permitted).
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- Previous enrolment in the present study.
- For female participants only: currently pregnant (confirmed with positive pregnancy test) or planning to become pregnant, breast-feeding, or intending to donate/retrieve ova before 6 months after the last dose of Saruparib.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Research Site
Liverpool, L7 8YA
- Recruiting
Research Site
Manchester, M20 4BX
About this study
Official title: A Phase I, Open-label Study to Assess the Absolute Bioavailability of Saruparib (AZD5305) and Absorption, Distribution, Metabolism, and Excretion (ADME) of [14C]-Saruparib ([14C]-AZD5305) in Patients With Advanced Solid Malignancies
This Phase I, open-label study aims to study to absolute bioavailability of Saruparib (AZD5305) and the absorption, distribution, metabolism and excretion (ADME) of [14C]-Saruparib in patients with advanced solid malignancies.
This will be done on an inpatient basis in 2 parts (single-dose oral administration with radiolabeled microtracer in Part A, single-dose IV radiolabeled administration in Part B) during which samples will be obtained of plasma, urine, feces and vomitus (where applicable).
Read the detailed description
This is an open-label, 2-part study in participants with advanced solid malignancies and will be conducted at multiple study sites.
Participants will be assessed for study eligibility prior to admission to the study site during a 28-day screening period. Participants will take part in both Parts A and B of the study.
Part A will assess the absolute bioavailability and evaluate the PK parameters of oral Saruparib and a radiolabelled IV microdose of [14C]-Saruparib
Participants will be admitted to the study site pre-dose of Part A and will remain resident at the study site for PK sampling and safety assessments.
A washout period will be observed between doses of Saruparib in Parts A and B.
Part B will assess the ADME of oral [14C]-Saruparib. Participants will be readmitted to the study site for Part B and will remain resident at the study site for excreta (urine, faeces, and any vomitus) collections, PK sampling, and safety assessments. Participants may be discharged from the study site prior to the last indicated day if both the following discharge criteria are met:
- ≥ 90% mass balance recovery, and
- < 1% of the total radioactive dose is recovered in combined excreta (urine and faeces) in 2 consecutive 24-hour periods.
Participants will return to the study site for a Follow-up Visit after the last dose of Saruparib which will include routine safety assessments. After the completion of Parts A and B, and following the Follow-up Visit, participants may be allowed further access to Saruparib.
Additional safety data collection will be conducted.
- Being tested
- Saruparib (AZD5305), [14C]-AZD5305 microtracer, [14C]-AZD5305 (therapeutic dose)
- Keywords
- hADME, saruparib, AZD5305, advanced solid tumour / tumor, neoplasm
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saruparib (AZD5305)Drug
Also called Saruparib
PARP-inhibitor
[14C]-AZD5305 microtracerDrug
Also called IV [14C]-Saruparib microtracer
IV radiolabeled microtracer
[14C]-AZD5305 (therapeutic dose)Drug
Also called IV [14C]-Saruparib (therapeutic dose)
IV radiolabeled PARP inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Primary Treatment Arm - AZD5305 | Experimental | Part A will assess absolute bioavailability via oral administration of Saruparib (AZD5305) and IV [14C]-saruparib microtracer.
Part B will assess ADME via IV [14C]-saruparib administration Receives: Drug: Saruparib (AZD5305); Drug: [14C]-AZD5305 microtracer; Drug: [14C]-AZD5305 (therapeutic dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability (F) of Saruparib
Absolute bioavailability (F) of Saruparib
Measured: Day 4
Total radioactivity recovery in urine and faeces
Total radioactivity recovery in urine and faeces
Measured: Day 8
Pharmacokinetics of Saruparib(Part B)
AUCinf
Measured: Day 8
PK parameters characterized by AUCinf
AUCinf
Measured: Day 4
Ratio of AUCinf of plasma Saruparib relative to AUCinf of metabolite
Ratio of AUCinf of plasma Saruparib relative to AUCinf of metabolite
Measured: Day 4
Mass balance parameters as characterized by amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined)
Cumulative amount excreted in urine, faeces and total (urine and faeces combined)
Measured: Day 8
Amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined) expressed as a percentage of the administered dose
Amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined) expressed as a percentage of the administered dose.
Measured: Day 8
Pharmacokinetics of Saruparib(Part B)
AUClast
Measured: Day 8
Pharmacokinetics of Saruparib(Part B)
Cmax
Measured: Day 8
Pharmacokinetics of Saruparib(Part B)
tmax
Measured: Day 8
Pharmacokinetics of Saruparib(Part B)
t1/2(lambda)z
Measured: Day 8
Pharmacokinetics of Saruparib(Part B)
Ratio of AUCinf of plasma Saruparib relative to AUCinf of plasma total radioactivity
Measured: Day 8
Pharmacokinetics of Saruparib(Part B)
Ratio of AUCinf of whole blood total radioactivity relative to AUCinf of plasma total radioactivity
Measured: Day 8
PK parameters characterized by AUClast
AUClast
Measured: Day 4
PK parameters characterized by Cmax
Cmax
Measured: Day 4
PK parameters characterized by tmax
tmax
Measured: Day 4
PK parameters characterized by t1/2(lambda)z
t1/2(lambda)z
Measured: Day 4
Secondary outcomes (2)
Metabolic profiling of a single oral dose of [14C]-Saruparib (Part B)
Determining mass balance parameters following oral administration of a therapeutic dose containing 20uCi of 14C-AZD5305 followed by metabolite profiling and identification in plasma, urine, and feces to quantify the 14C-AZD5305 related material in each matrix to satisfy MIST considerations.
Measured: Day 8
Characterize the safety of Saruparib in participants with advanced solid malignancies by incidence and severity of AEs, laboratory abnormalities, 12-lead ECG abnormalities, vital signs abnormalities, physical examination findings
incidence and severity of AEs, -incidence of laboratory abnormalities (based on hematology, clinical chemistry, and urinalysis test results), -12-lead ECG abnormalities, vital signs abnormalities, physical examination findings
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start2 Apr 2025
- Primary completion2 Oct 2026 (estimated)
- Study completion2 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorStudies 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Approximately 8 patients will be enrolled, all will be assigned to the same treatment arm with no randomization or masking. All eligible patients will begin dosing in Part A, followed by a washout period, followed by Part B.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713369
- Sponsor's protocol ID
- D9723C00004
- Acronym
- AZD5305
- Status last verified
- Jun 2026
- First submitted
- 30 Jul 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study to Assess the Absolute Bioavailability of Saruparib (AZD5305) and Absorption, Distribution, Metabolism, and Excretion (ADME) of [14C]-Saruparib ([14C]-AZD5305) in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT06713369
- Acronym / sponsor ID
- AZD5305 / D9723C00004
- Keywords
- hADME, saruparib, AZD5305, advanced solid tumour / tumor, neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 2 Oct 2026 (estimated)
- Study completion
- 2 Oct 2026 (estimated)
- First posted
- 3 Dec 2024 (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.
This Phase I, open-label study aims to study to absolute bioavailability of Saruparib (AZD5305) and the absorption, distribution, metabolism and excretion (ADME) of [14C]-Saruparib in patients with advanced solid malignancies.
This will be done on an inpatient basis in 2 parts (single-dose oral administration with radiolabeled microtracer in Part A, single-dose IV radiolabeled administration in Part B) during which samples will be obtained of plasma, urine, feces and vomitus (where applicable).
Detailed description
This is an open-label, 2-part study in participants with advanced solid malignancies and will be conducted at multiple study sites.
Participants will be assessed for study eligibility prior to admission to the study site during a 28-day screening period. Participants will take part in both Parts A and B of the study.
Part A will assess the absolute bioavailability and evaluate the PK parameters of oral Saruparib and a radiolabelled IV microdose of [14C]-Saruparib
Participants will be admitted to the study site pre-dose of Part A and will remain resident at the study site for PK sampling and safety assessments.
A washout period will be observed between doses of Saruparib in Parts A and B.
Part B will assess the ADME of oral [14C]-Saruparib. Participants will be readmitted to the study site for Part B and will remain resident at the study site for excreta (urine, faeces, and any vomitus) collections, PK sampling, and safety assessments. Participants may be discharged from the study site prior to the last indicated day if both the following discharge criteria are met:
- ≥ 90% mass balance recovery, and
- < 1% of the total radioactive dose is recovered in combined excreta (urine and faeces) in 2 consecutive 24-hour periods.
Participants will return to the study site for a Follow-up Visit after the last dose of Saruparib which will include routine safety assessments. After the completion of Parts A and B, and following the Follow-up Visit, participants may be allowed further access to Saruparib.
Additional safety data collection will be conducted.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Approximately 8 patients will be enrolled, all will be assigned to the same treatment arm with no randomization or masking. All eligible patients will begin dosing in Part A, followed by a washout period, followed by Part B.
| Arm | Type | Receives |
|---|---|---|
| Primary Treatment Arm - AZD5305 | Experimental | Drug: Saruparib (AZD5305), Drug: [14C]-AZD5305 microtracer, Drug: [14C]-AZD5305 (therapeutic dose)Part A will assess absolute bioavailability via oral administration of Saruparib (AZD5305) and IV [14C]-saruparib microtracer. Part B will assess ADME via IV [14C]-saruparib administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the ICF.
- Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable.
- ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to dosing.
- Predicted life expectancy ≥ 12 weeks.
- Adequate organ and marrow function as defined in the protocol
Key exclusion criteria (29 listed)
- Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). Specific screening for MDS/AML is not required.
- Participants with any known predisposition to bleeding
- Any history of persisting severe cytopenia due to any cause
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of Saruparib.
- History of another primary malignancy, with some exceptions
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 |
|---|---|---|
| Saruparib (AZD5305)Also: SaruparibPARP-inhibitor | Drug | Primary Treatment Arm - AZD5305 |
| [14C]-AZD5305 microtracerAlso: IV [14C]-Saruparib microtracerIV radiolabeled microtracer | Drug | Primary Treatment Arm - AZD5305 |
| [14C]-AZD5305 (therapeutic dose)Also: IV [14C]-Saruparib (therapeutic dose)IV radiolabeled PARP inhibitor | Drug | Primary Treatment Arm - AZD5305 |
Primary outcome
Absolute bioavailability (F) of Saruparib
Time frame: Day 4
Absolute bioavailability (F) of Saruparib
Total radioactivity recovery in urine and faeces
Time frame: Day 8
Total radioactivity recovery in urine and faeces
Pharmacokinetics of Saruparib(Part B)
Time frame: Day 8
AUCinf
PK parameters characterized by AUCinf
Time frame: Day 4
AUCinf
Ratio of AUCinf of plasma Saruparib relative to AUCinf of metabolite
Time frame: Day 4
Ratio of AUCinf of plasma Saruparib relative to AUCinf of metabolite
Mass balance parameters as characterized by amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined)
Time frame: Day 8
Cumulative amount excreted in urine, faeces and total (urine and faeces combined)
Amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined) expressed as a percentage of the administered dose
Time frame: Day 8
Amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined) expressed as a percentage of the administered dose.
Pharmacokinetics of Saruparib(Part B)
Time frame: Day 8
AUClast
Pharmacokinetics of Saruparib(Part B)
Time frame: Day 8
Cmax
Pharmacokinetics of Saruparib(Part B)
Time frame: Day 8
tmax
Pharmacokinetics of Saruparib(Part B)
Time frame: Day 8
t1/2(lambda)z
Pharmacokinetics of Saruparib(Part B)
Time frame: Day 8
Ratio of AUCinf of plasma Saruparib relative to AUCinf of plasma total radioactivity
Pharmacokinetics of Saruparib(Part B)
Time frame: Day 8
Ratio of AUCinf of whole blood total radioactivity relative to AUCinf of plasma total radioactivity
PK parameters characterized by AUClast
Time frame: Day 4
AUClast
PK parameters characterized by Cmax
Time frame: Day 4
Cmax
PK parameters characterized by tmax
Time frame: Day 4
tmax
PK parameters characterized by t1/2(lambda)z
Time frame: Day 4
t1/2(lambda)z
2 secondary outcomes
Metabolic profiling of a single oral dose of [14C]-Saruparib (Part B)
Time frame: Day 8
Characterize the safety of Saruparib in participants with advanced solid malignancies by incidence and severity of AEs, laboratory abnormalities, 12-lead ECG abnormalities, vital signs abnormalities, physical examination findings
Time frame: Day 14
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 24 Jun 2026.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Saruparib (AZD5305), [14C]-AZD5305 microtracer and [14C]-AZD5305 (therapeutic dose) in people with Locally Advanced or Metastatic Solid Tumor, run by AstraZeneca at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 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.
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?
Absolute bioavailability (F) of Saruparib (time frame: Day 4). The study lists 17 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 24 Jun 2026.