Solid TumorPhase 1NCT05678010
A Study of AZD1390 and Stereotactic Body Radiotherapy (SBRT) for People With Metastatic Solid Tumor Cancer
A Phase 1 study testing AZD1390 and Stereotactic Body Radiotherapy in people with Solid Tumor and Metastatic Solid Tumor, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
The purpose of this study is to find out whether AZD1390 combined with stereotactic body radiation therapy/SBRT is a safe treatment for people with metastatic solid tumor cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Metastatic Solid Tumor, Solid Carcinoma
- What is being tested?
- AZD1390 and Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 May 2023to 17 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- Aged at least 18 years.
- Karnofsky Performance Score (KPS) of ≥60.
- Histologically confirmed diagnosis of cancer with clear evidence of metastasis on imaging. Confirmation of metastasis by biopsy is preferred but not required.
- Candidates for SBRT delivered as 6Gy x 5 daily fractions to 2 sites of disease. The radiation plan should meet departmental guidelines. Patients can have more than 2 sites of disease. If patient requires RT to other sites of disease this can be done after completion of DLT period.
- Adequate organ system functions, as outlined below:
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- Absolute neutrophil count (ANC) ≥1.0 x 109/L
- Platelets ≥75 x 109/L
- Hemoglobin ≥8 g/dL
- Total bilirubin ≤1.5 times the ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the ULN if no liver involvement or ≤5 times the ULN with liver involvement with metastatic disease.
- Creatinine <1.5 times ULN concurrent with creatinine clearance >50 mL/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.
- Lipase within normal limits (WNL)
- Creatine kinase (CK) ≤5 times ULN
- Females of childbearing potential must have a negative pregnancy test during screening and must not be breastfeeding or intending to become pregnant during the study. Male patients with female partners of child-bearing potential must be willing to use two forms of acceptable contraception, including one barrier method, during their participation in this study and for 16 weeks following the last dose of the study drug.
- Ability to swallow and retain oral medication.
Who cannot join
- Prior radiotherapy to the same region within the last 3 months.
- Ongoing treatment for brain metastases. Patients with brain metastases may participate in this trial however, treatment for brain metastases will have to be completed prior to study enrollment. Treatments can begin or resume two weeks after completing protocol therapy.
- History of epilectic disorder.
- For Arm B patients with cancers involving the spinal cord, the length of the spinal cord lesion requiring palliative treatment is greater than 10 cm.
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- Evidence of established ILD on screening CT scan.
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- Evidence of severe pulmonary infections, as judged by the investigator, based on clinical findings and investigations.
- Concurrent severe and/or uncontrolled medical condition (e.g., severe COPD).
- Cardiac dysfunction defined as: Myocardial infarction within six months of study entry, NYHA Class II/III/IV heart failure, unstable angina or unstable cardiac arrhythmias.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs) (QTc interval will be calculated using Fridericia's formula).
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age. Patients stable on concomitant medications known to prolong the QT interval may be allowed to participate in the study provided that their mean resting corrected QT interval \(QTcF) is < 470 msec at baseline.
- History or presence of myopathy or raised CK >5 x ULN on 2 occasions at screening.
- Anticancer therapy within 7 days of first SBRT. These treatments should also be held for 7 days after last dose of SBRT. Patients who have received an immune checkpoint inhibitor within 28 days of first administration of study therapy will be excluded.
- History of hypersensitivity to AZD1390 and excipients or drugs with a similar chemical structure or class to AZD1390.
- Patients receiving treatment with strong inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of AZD1390.
- Patients who require sensitive substrates of BCRP, OATP1B1, MATE1, MATE2K and P-gp such as prazosin, cimetidine, simvastatin, dofetilide, metformin, dabigatran, digoxin and fexofenadine should be avoided while on study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
University of Washington (Data Collection AND Data Analysis)
Seattle, Washington, 98109
About this study
Official title: A Phase I Study Assessing the Safety and Tolerability of Ascending Doses of AZD1390 in Combination With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Solid Tumor Malignancies
The purpose of this study is to find out whether AZD1390 combined with stereotactic body radiation therapy/SBRT is a safe treatment for people with metastatic solid tumor cancer
- Conditions
- Solid Tumor, Metastatic Solid Tumor, Solid Carcinoma, Solid Tumor, Adult, Metastatic Tumor, Metastatic Cancer
- Being tested
- AZD1390, Stereotactic Body Radiotherapy
- Keywords
- Solid Tumor, Metastatic Solid Tumor, Solid Carcinoma, Metastatic Tumor, Metastatic Cancer, 22-042, Memorial Sloan Kettering Cancer Center, AZD1390
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1390Drug
Dose level 1: 20 Dose level 2: 40 Dose level 3: 60 Dose level 4: 80
Stereotactic Body RadiotherapyRadiation
Also called SBRT
Participants will receive Stereotactic Body Radiotherapy/SBRT to 2 sites of metastatic tumors consecutively. The two treatment sites will be randomized to SBRT to one site and SBRT + AZD1390 to the other site. Both sites will receive 30Gy in 5 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Arm A, Dose Level 1 | Experimental | Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level). Receives: Drug: AZD1390; Radiation: Stereotactic Body Radiotherapy |
| Arm A, Dose Level 2 | Experimental | Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level). Receives: Drug: AZD1390; Radiation: Stereotactic Body Radiotherapy |
| Arm A, Dose Level 3 | Experimental | Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level). Receives: Drug: AZD1390; Radiation: Stereotactic Body Radiotherapy |
| Arm A, Dose Level 4 | Experimental | Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level). Receives: Drug: AZD1390; Radiation: Stereotactic Body Radiotherapy |
| Arm B, Dose Level 1 | Experimental | Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target Receives: Drug: AZD1390; Radiation: Stereotactic Body Radiotherapy |
| Arm B, Dose Level 2 | Experimental | Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target Receives: Drug: AZD1390; Radiation: Stereotactic Body Radiotherapy |
| Arm B, Dose Level 3 | Experimental | Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target Receives: Drug: AZD1390; Radiation: Stereotactic Body Radiotherapy |
| Arm B, Dose Level 4 | Experimental | Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target Receives: Drug: AZD1390; Radiation: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess participants for toxicities related to study treatment
The primary objective is to assess the safety and tolerability of concurrent AZD1390 with SBRT for patients with solid tumor metastases with solid tumor metastases. Participant toxicities will be assessed using the CTCAE v5.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start17 May 2023
- Primary completion17 May 2028 (estimated)
- Study completion17 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Daniel Higginson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678010
- Sponsor's protocol ID
- 22-042
- Status last verified
- May 2026
- First submitted
- 28 Dec 2022
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Assessing the Safety and Tolerability of Ascending Doses of AZD1390 in Combination With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT05678010
- Acronym / sponsor ID
- 22-042
- Conditions
- Solid Tumor, Metastatic Solid Tumor, Solid Carcinoma, Solid Tumor, Adult, Metastatic Tumor, Metastatic Cancer
- Keywords
- Solid Tumor, Metastatic Solid Tumor, Solid Carcinoma, Metastatic Tumor, Metastatic Cancer, 22-042, Memorial Sloan Kettering Cancer Center, AZD1390
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 17 May 2023 (actual)
- Primary completion
- 17 May 2028 (estimated)
- Study completion
- 17 May 2028 (estimated)
- First posted
- 10 Jan 2023 (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.
The purpose of this study is to find out whether AZD1390 combined with stereotactic body radiation therapy/SBRT is a safe treatment for people with metastatic solid tumor cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Arm A, Dose Level 1 | Experimental | Drug: AZD1390, Radiation: Stereotactic Body RadiotherapyParticipants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level). |
| Arm A, Dose Level 2 | Experimental | Drug: AZD1390, Radiation: Stereotactic Body RadiotherapyParticipants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level). |
| Arm A, Dose Level 3 | Experimental | Drug: AZD1390, Radiation: Stereotactic Body RadiotherapyParticipants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level). |
| Arm A, Dose Level 4 | Experimental | Drug: AZD1390, Radiation: Stereotactic Body RadiotherapyParticipants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target [PTV]) may be triggered at the initial dose level). |
| Arm B, Dose Level 1 | Experimental | Drug: AZD1390, Radiation: Stereotactic Body RadiotherapyParticipants have peripheral metastasis with bowel and lung in SBRT treatment planning target |
| Arm B, Dose Level 2 | Experimental | Drug: AZD1390, Radiation: Stereotactic Body RadiotherapyParticipants have peripheral metastasis with bowel and lung in SBRT treatment planning target |
| Arm B, Dose Level 3 | Experimental | Drug: AZD1390, Radiation: Stereotactic Body RadiotherapyParticipants have peripheral metastasis with bowel and lung in SBRT treatment planning target |
| Arm B, Dose Level 4 | Experimental | Drug: AZD1390, Radiation: Stereotactic Body RadiotherapyParticipants have peripheral metastasis with bowel and lung in SBRT treatment planning target |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Willing and able to provide written informed consent
- Aged at least 18 years.
- Karnofsky Performance Score (KPS) of ≥60.
- Histologically confirmed diagnosis of cancer with clear evidence of metastasis on imaging. Confirmation of metastasis by biopsy is preferred but not required.
- Candidates for SBRT delivered as 6Gy x 5 daily fractions to 2 sites of disease. The radiation plan should meet departmental guidelines. Patients can have more than 2 sites of disease. If patient requires RT to other sites of disease this can be done after completion of DLT period.
Key exclusion criteria (18 listed)
- Prior radiotherapy to the same region within the last 3 months.
- Ongoing treatment for brain metastases. Patients with brain metastases may participate in this trial however, treatment for brain metastases will have to be completed prior to study enrollment. Treatments can begin or resume two weeks after completing protocol therapy.
- History of epilectic disorder.
- For Arm B patients with cancers involving the spinal cord, the length of the spinal cord lesion requiring palliative treatment is greater than 10 cm.
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
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 |
|---|---|---|
| AZD1390Dose level 1: 20 Dose level 2: 40 Dose level 3: 60 Dose level 4: 80 | Drug | Arm A, Dose Level 1, Arm A, Dose Level 2, Arm A, Dose Level 3, Arm A, Dose Level 4, Arm B, Dose Level 1, Arm B, Dose Level 2, Arm B, Dose Level 3, Arm B, Dose Level 4 |
| Stereotactic Body RadiotherapyAlso: SBRTParticipants will receive Stereotactic Body Radiotherapy/SBRT to 2 sites of metastatic tumors consecutively. The two treatment sites will be randomized to SBRT to one site and SBRT + AZD1390 to the other site. Both sites will receive 30Gy in 5 fractions. | Radiation | Arm A, Dose Level 1, Arm A, Dose Level 2, Arm A, Dose Level 3, Arm A, Dose Level 4, Arm B, Dose Level 1, Arm B, Dose Level 2, Arm B, Dose Level 3, Arm B, Dose Level 4 |
Primary outcome
Assess participants for toxicities related to study treatment
Time frame: 1 year
The primary objective is to assess the safety and tolerability of concurrent AZD1390 with SBRT for patients with solid tumor metastases with solid tumor metastases. Participant toxicities will be assessed using the CTCAE v5.0
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 18 May 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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. This study is not recruiting at the moment.
Daniel Higginson, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 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 and Stereotactic Body Radiotherapy in people with Solid Tumor and Metastatic Solid Tumor, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
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 16 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess participants for toxicities related to study treatment (time frame: 1 year). 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 18 May 2026.