Tracing a cancer Drug's path through the body
NCT ID NCT06754761
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This early-phase study by AstraZeneca examines how the experimental drug ceralasertib is absorbed, distributed, and eliminated in people with advanced solid tumors. Participants receive the drug orally and a tiny radiolabeled intravenous dose to track its journey. Researchers measure drug levels in blood, urine, and feces to understand its behavior and safety. The goal is to gather detailed information that could guide future dosing and development of ceralasertib.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ceralasertib (AZD6738), an experimental ATR inhibitor drug, given orally and as a radiolabeled intravenous microdose
- What this could lead to
- If successful, this study could refine dosing and safety for ceralasertib, supporting its development as a potential treatment for advanced solid tumors.
- What could go wrong
- This is a very small early-phase study focused on drug behavior, not treatment effect. It may not show clinical benefit, and the radiolabeled tracer carries a small radiation risk.
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
-
2 people
The number who actually took part.
- Started
-
Sep 2025
- Finished
-
Oct 2025
- 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
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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 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: * Participants are eligible to be included in the study only if all of the following criteria apply: Age 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. Type of Participant and Disease Characteristics 2. Sufficient ECOG performance status, life expectancy, and ability to swallow and retain oral medication 3. Adequate organ and marrow function 4. Willingness and ability to comply with study and follow-up procedures. 5. Able and willing to stay in hospital for specified residential periods following administration of Ceralasertib/\[14C\]-Ceralasertib 6. Regular bowel movements 7. Locally advanced or metastatic solid tumour, for which standard therapy does not exist or has proven to be ineffective or intolerable. 8. Sex and Contraceptive/Barrier Requirements: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 9. Informed Consent: patient must be capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Exclusion Criteria: * Participants are excluded from the study if any of the following criteria apply: 1. History of Diagnosis of protocol-specified medical conditions 2. Spinal cord compression or brain metastasis prior to start of study intervention unless asymptomatic and stable 3. Persistent toxicities (CTCAE Grade ≥ 2), with the exception of alopecia and vitiligo, caused by previous anticancer therapy. 4. Any medical or surgical condition that would preclude adequate absorption of Ceralasertib 5. Inadequate cardiac function / status or other cardiovascular diseases 6. Participants with active infection requiring systemic antibiotics, antifungal or antiviral drugs 7. Any evidence of severe or uncontrolled systemic disease, as judged by the investigator that would make it undesirable for the participant to participate in the study or would jeopardise compliance with the protocol 8. Protocol-specified prior/concomitant therapy exclusions 9. Protocol-specified prior/concurrent clinical study experience 10. Other Exclusions including but not limited to tobacco/nicotine and/or alcohol use, or drug/alcohol abuse history 11. Not currently pregnant, breast-feeding, or planning to become pregnant
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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.
Contacts and locations
Locations
-
Research Site
Liverpool, L7 8YA, United Kingdom
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