Advanced Solid MalignanciesPhase 1NCT07643870
Human ADME Study of [14C]-AZD1390
A Phase 1 study testing AZD1390 in people with Advanced Solid Malignancies, run by AstraZeneca at 2 sites in United Kingdom.
Trial summary
This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of [14C]-AZD1390. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- AZD1390
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 Jun 2026to 12 Apr 2028
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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
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
Research Site
Guildford, GU2 7WG
Research Site
Liverpool, L7 8XP
About this study
Official title: A Phase I, Open-label Study to Assess the Absorption, Distribution, Metabolism, and Excretion (ADME) of AZD1390 After a Single Oral Dose of [14C]-AZD1390 in Participants With Advanced Solid Malignancies
This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of [14C]-AZD1390.
Read the detailed description
On Day 1, participants will receive one dose of [14C]-AZD1390 . Participants will be confined to the study site until Day 8.
Approximately 8 enrolled male and female participants will receive study intervention in order to achieve a minimum of 4 evaluable participants.
Participants in this study will contribute to essential knowledge that will support the development of AZD1390 as a potential treatment for GBM, a malignancy of high unmet need, while being exposed to a low level of immediate risk.
- Conditions
- Advanced Solid Malignancies
- Being tested
- AZD1390
- Keywords
- AZD1390, Malignancies, Solid tumor, Glioblastoma, Radioactivity / radiation, Metabolite / metabolism, ATM kinase inhibitor, Pharmacokinetics, Single-dose, ADME
- Medical subject headings
- Neoplasms, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1390Drug
single dose
| Study group | Role | What they receive |
|---|---|---|
| AZD1390 | Experimental | Single dose of [14C]-AZD1390 Receives: Drug: AZD1390 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Amount excreted (Ae) (urine)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Cumulative Amount excreted (CumAe) (urine)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Amount excreted (Ae) (feaces)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Cumulative Amount excreted (CumAe) (feaces)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Amount excreted (Ae) (total - urine and feaces combined)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Cumulative Amount excreted (CumAe) (total urine and feaces combined)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Amount (percentage) excreted (Fe) (urine)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Cumulative Amount (percentage) excreted (CumFe) (urine)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Amount (percentage) excreted (Fe) (feaces)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Cumulative Amount (percentage) excreted (CumAe) (feaces)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Amount (percentage) excreted (Fe) (total urine and faeces combined)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Cumulative Amount (percentage) excreted (CumFe) (total urine and faeces combined)
Measured: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
If emesis occurs, vomitus will be analysed for total radioactivity
Measured: 6 Weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of plasma: Maximum observed concentration (Cmax)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis whole blood: Maximum observed concentration (Cmax)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of whole blood: Area under the concentration-time curve from zero to infinity (AUCinf)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of whole blood: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of whole blood: Time to reach maximum observed plasma concentration (Tmax)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of whole blood: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of whole blood: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of plasma: Mean residence time of the unchanged drug in the systemic circulation (MRT)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of whole blood: Mean residence time of the unchanged drug in the systemic circulation (MRT)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of whole blood: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Analysis of whole blood: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Ratio of AUCinf of plasma AZD1390 relative to AUCinf of plasma total radioactivity
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Ratio of AUCinf of whole blood total radioactivity to AUCinf of plasma total radioactivity
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose
Analysis of urine: Cumulative amount excreted (CumAe)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose
Analysis of urine: Fraction (percentage) excreted (Fe)
Measured: 6 weeks
The distribution of total radioactivity into blood cells after a single oral dose
Analysis of urine: Fraction (percentage) excreted (Fe)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose
Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)
Measured: 6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose
Analysis of urine: Renal clearance (CLR)
Measured: 6 weeks
Secondary outcomes (16)
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Maximum observed concentration (Cmax)
Measured: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
Measured: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
Measured: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
Measured: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
Measured: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Measured: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
Measured: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Measured: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of metabolite in plasma: parent ratio
Measured: 6 weeks
Metabolic profiling following single oral dose of AZD1390
Quantification and identification of major metabolites of AZD1390 in plasma and excreta.
Measured: 6 weeks
The safety of a single dose of AZD1390
Number of participants with AEs and SAEs and severity of AEs and SAEs (based on CTCAE v5).
Measured: 6 weeks
The safety of a single dose of AZD1390
Number of participants with laboratory abnormalities based on assessment of Haematology/Haemostasis (whole blood), Urinalysis (dipstick), Serology, Clinical chemistry (serum or plasma), Creatinine clearance.
Measured: 6 weeks
The safety of a single dose of AZD1390
Number of participants with abnormal ECG and measurement of heart rate, PR QRS, QT and QTcF intervals (in milliseconds)
Measured: 6 weeks
The safety of a single dose of AZD1390
Number of participants with abnormal vital signs based on assessment of body temperature, pulse rate, and blood pressure completed with automated devices.
Measured: 6 weeks
The safety of a single dose of AZD1390
Assessment of weight (measurement units can be variable) throughout the study.
Measured: 6 weeks
The safety of a single dose of AZD1390
Number of participants with abnormal physical examination based on assessment of general appearance, respiratory, cardiovascular, abdomen, skin, head and neck, lymph nodes, thyroid, musculoskeletal, and neurological systems.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion12 Apr 2028 (estimated)
- Study completion12 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid MalignanciesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643870
- Sponsor's protocol ID
- D6940C00006
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 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 Absorption, Distribution, Metabolism, and Excretion (ADME) of AZD1390 After a Single Oral Dose of [14C]-AZD1390 in Participants With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT07643870
- Acronym / sponsor ID
- D6940C00006
- Conditions
- Advanced Solid Malignancies
- Keywords
- AZD1390, Malignancies, Solid tumor, Glioblastoma, Radioactivity / radiation, Metabolite / metabolism, ATM kinase inhibitor, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 12 Apr 2028 (estimated)
- Study completion
- 12 Apr 2028 (estimated)
- First posted
- 12 Jun 2026 (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 is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of [14C]-AZD1390.
Detailed description
On Day 1, participants will receive one dose of [14C]-AZD1390 . Participants will be confined to the study site until Day 8.
Approximately 8 enrolled male and female participants will receive study intervention in order to achieve a minimum of 4 evaluable participants.
Participants in this study will contribute to essential knowledge that will support the development of AZD1390 as a potential treatment for GBM, a malignancy of high unmet need, while being exposed to a low level of immediate risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| AZD1390 | Experimental | Drug: AZD1390Single dose of [14C]-AZD1390 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
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 |
|---|---|---|
| AZD1390single dose | Drug | AZD1390 |
Primary outcome
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Amount excreted (Ae) (urine)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Cumulative Amount excreted (CumAe) (urine)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Amount excreted (Ae) (feaces)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Cumulative Amount excreted (CumAe) (feaces)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Amount excreted (Ae) (total - urine and feaces combined)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Cumulative Amount excreted (CumAe) (total urine and feaces combined)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Amount (percentage) excreted (Fe) (urine)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Cumulative Amount (percentage) excreted (CumFe) (urine)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Amount (percentage) excreted (Fe) (feaces)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Cumulative Amount (percentage) excreted (CumAe) (feaces)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Amount (percentage) excreted (Fe) (total urine and faeces combined)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
Cumulative Amount (percentage) excreted (CumFe) (total urine and faeces combined)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Time frame: 6 Weeks
If emesis occurs, vomitus will be analysed for total radioactivity
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of plasma: Maximum observed concentration (Cmax)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis whole blood: Maximum observed concentration (Cmax)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of whole blood: Area under the concentration-time curve from zero to infinity (AUCinf)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of whole blood: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of whole blood: Time to reach maximum observed plasma concentration (Tmax)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of whole blood: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of whole blood: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of plasma: Mean residence time of the unchanged drug in the systemic circulation (MRT)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of whole blood: Mean residence time of the unchanged drug in the systemic circulation (MRT)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of whole blood: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of whole blood: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Ratio of AUCinf of plasma AZD1390 relative to AUCinf of plasma total radioactivity
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Ratio of AUCinf of whole blood total radioactivity to AUCinf of plasma total radioactivity
Pharmacokinetic(s) of AZD1390 after a single oral dose
Time frame: 6 weeks
Analysis of urine: Cumulative amount excreted (CumAe)
Pharmacokinetic(s) of AZD1390 after a single oral dose
Time frame: 6 weeks
Analysis of urine: Fraction (percentage) excreted (Fe)
The distribution of total radioactivity into blood cells after a single oral dose
Time frame: 6 weeks
Analysis of urine: Fraction (percentage) excreted (Fe)
Pharmacokinetic(s) of AZD1390 after a single oral dose
Time frame: 6 weeks
Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)
Pharmacokinetic(s) of AZD1390 after a single oral dose
Time frame: 6 weeks
Analysis of urine: Renal clearance (CLR)
16 secondary outcomes
The phamrmacokinetic(s) of AZD1390 metabolite
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Time frame: 6 weeks
Metabolic profiling following single oral dose of AZD1390
Time frame: 6 weeks
The safety of a single dose of AZD1390
Time frame: 6 weeks
The safety of a single dose of AZD1390
Time frame: 6 weeks
The safety of a single dose of AZD1390
Time frame: 6 weeks
The safety of a single dose of AZD1390
Time frame: 6 weeks
The safety of a single dose of AZD1390
Time frame: 6 weeks
The safety of a single dose of AZD1390
Time frame: 6 weeks
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 12 Jun 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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 AZD1390 in people with Advanced Solid Malignancies, 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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 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?
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose (time frame: 6 Weeks). The study lists 38 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 12 Jun 2026.