Tiny study tracks cancer Drug's journey through the body

NCT ID NCT06713369

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

cancer neoplasm Neoplasm Metastasis

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Research Site

    RECRUITING

    Liverpool, L7 8YA, United Kingdom

  • Research Site

    RECRUITING

    Manchester, M20 4BX, United Kingdom

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