Tiny study tracks cancer Drug's journey through the body
NCT ID NCT06713369
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study looks at how the experimental drug saruparib is absorbed, distributed, and eliminated in 8 people with advanced solid tumors. Participants will receive the drug by mouth and by vein, with samples taken to track the drug and its breakdown products. The goal is to understand the drug's behavior in the body, not to treat the cancer directly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Saruparib (AZD5305)
- What this could lead to
- If successful, this study will help determine the right dose of saruparib for future trials, potentially leading to better treatment options for advanced solid tumors.
- What could go wrong
- This is a very early, small study (only 8 people) focused on drug behavior, not on treating the cancer. It may not lead to any direct benefit for participants or future patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. 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. 3. ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to dosing. 4. Predicted life expectancy ≥ 12 weeks. 5. Adequate organ and marrow function as defined in the protocol 6. Willingness and ability to comply with study and follow-up procedures. 7. Able and willing to stay in hospital for specified residential periods following administration of Saruparib/\[14C\]-Saruparib 8. Regular bowel movements 9. Body weight within normal range specified in protocol 10. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Reproduction 11. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol Exclusion Criteria: 1. 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. 2. Participants with any known predisposition to bleeding 3. Any history of persisting severe cytopenia due to any cause 4. 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. 5. History of another primary malignancy, with some exceptions 6. Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy. 7. Spinal cord compression or brain metastases for at least 4 weeks prior to start of study intervention unless asymptomatic and stable 8. Abnormal cardiac function exclusions or cardiovascular disease 9. History of arrhythmia 10. Active HBV (positive HBsAg result) or HCV. 11. Evidence of active and uncontrolled HIV infection. 12. Active tuberculosis infection 13. 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. 14. 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. 15. Any prior treatment with a PARP inhibitor or platinum chemotherapy. 16. 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. 17. 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 18. Concomitant use of medications or herbal supplements known to be CYP3A4 strong and moderate inhibitors or inducers 19. Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes 20. Participants who have participated in another absorption, distribution, metabolism, and excretion study within 1 year prior to screening. 21. 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. 22. Participants with a known hypersensitivity to Saruparib or any of the excipients of the product. 23. Participants who have been administered any amount of a \[14C\]-labelled compound within the last 12 months. 24. Use of tobacco- or nicotine-containing products or alcohol may be exclusionary 25. Poor peripheral venous access (venous access via a port will be permitted). 26. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 27. 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. 28. Previous enrolment in the present study. 29. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
RECRUITINGLiverpool, L7 8YA, United Kingdom
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Research Site
RECRUITINGManchester, M20 4BX, United Kingdom
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