Not Yet RecruitingPhase 1

Human ADME Study of [14C]-AZD1390

United Kingdom8 participantsStarted 2026-06-30

Plain-language summary

This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of \[14C\]-AZD1390.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment, * ECOG performance status of 0 or 1 with no deterioration over the 2 weeks, * Predicted life expectancy ≥ 12 weeks, * Adequate organ and marrow function, * Creatinine clearance ≥ 50 mL/min, * Regular bowel movements, * No cancer-associated cachexia (weight loss). Exclusion Criteria: * History or presence of myopathy or raised CK \> 5 × ULN at screening, * History of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, * History or presence of clinically significant hepatic disease, * History of epileptic disorder or any seizure history unrelated to tumour, * History of MDS/AML or with features suggestive of MDS/AML, * Predisposition to bleeding * History of persisting (\> 2 weeks) severe cytopenia * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection * History of another primary malignancy * Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy, * Spinal cord compression or brain metastases for at least 4 weeks

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial involves giving me a single dose of a radioactive (carbon-14 labeled) form of AZD1390 mainly to track how my body breaks it down and eliminates it — rather than to treat my cancer — is it worth discussing whether this study could fit alongside or delay any active treatment I might need?
2This is a Phase 1 study that hasn't started recruiting yet, so safety and benefit data in patients are still very early — can you help me understand what is currently known about AZD1390's safety profile, and what the risks of receiving a radioactively labeled version of this drug could mean for me specifically?
3Because the main goal here is to collect detailed samples — like blood, urine, and possibly stool — to measure how the radioactive drug and its breakdown products move through my body, how intensive and time-consuming would the sample collection process likely be, and would I need to be confined to a clinical facility for a period of time?
4Since I have advanced solid malignancies, would participating in this kind of metabolic tracking study leave the door open for me to enroll in other trials or receive standard treatments at the same time, or could it affect my eligibility for those options?
5Given that this trial is not yet recruiting, what is your best estimate of when it might open, and in the meantime, what standard treatment or other clinical trial options should we be actively considering for my specific cancer?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Trial details

NCT IDNCT07643870

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-12

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Advanced Solid Malignancies trials

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Timeframe: 6 Weeks

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose