Solid Tumor, Unspecified, AdultATMNCT04976803
Tissue Collection for Correlation Between ATM Alterations by Next-Generation Sequencing and ATM Loss-of-Protein
An observational study of Solid Tumor, Unspecified, Adult, run by Artios Pharma Ltd at 3 sites in 2 countries.
Trial summary
This study examines the correlation between ATM alterations identified using NGS profiles with ATM protein expression levels from tumor tissue assessed by IHC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Unspecified, Adult
- What is being tested?
- Determination of ATM alteration status.
- How many people
- 229 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 May 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with identified ATM alterations will be potentially enrolled into this study in 1 of 3 patient populations * Group A: Deceased patients with archival tumor tissue * Group B: Living patients with archival tumor tissue * Group C: Living patients without archival tumor tissue
Who may be able to join
- Patients must meet the following criteria in order to be included in the research study:
- All patients (Groups A, B, and C) must meet the following criteria:
- Previous genetic testing of ATM genomic aberrations.
- ≥18 years of age.
- All living patients (Groups B and C) must also meet the additional criteria:
- Signed written informed consent to access archival tissue, if available.
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- All Group C patients must also meet the additional criteria:
- Provided signed written informed consent to collect a fresh core biopsy.
- Have a non-irradiated, biopsiable tumor site to allow sampling for analysis via IHC for loss of ATM protein.
- Potentially eligible for REFMAL 721/ART0380C001:
- Have not received a previous treatment targeting the ATR/CHK1 pathway.
- If patients have a germline BRCA mutation or a cancer with a somatic BRCA mutation or which is HRD positive and for which there is an approved PARP inhibitor, patients should have received such treatment.
- Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator
- Advanced or metastatic cancer which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study.
- Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
Who cannot join
- There are no exclusion criteria for patients in Group A and Group B.
- Group C patients who meet any of the following criteria will be excluded from study entry:
- Have a significant bleeding disorder or vasculitis or had a Grade 3 bleeding episode within 12 weeks prior to enrollment.
- Presumed ineligible for enrollment to REFMAL 721/ART0380C001:
- Psychological, familial, sociological, or geographical conditions that that would compromise the patient's ability to adhere to future procedures likely in a Phase I protocol (such as REFMAL 721/ ART0380C001).
- Women who are pregnant, breast feeding, or who plan to become pregnant within the next 6 months.
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- Men who plan to father a child within the next 6 months.
- Have a serious concomitant systemic disorder that would compromise the patient's ability to adhere to a future protocol (REFMAL 721/ ART0380C001) including:
- One or more opportunistic HIV/AIDs-related infections within the past 12 months.
- Documented active or chronic infection with hepatitis B virus (positive hepatitis B surface antigen [+HBsAg]), or hepatitis C virus.
- Known history of clinical diagnosis of tuberculosis.
- Have had a malignancy prior to the current malignancy. Patients with carcinoma in situ of any origin and patients with prior malignancies who are in remission and whose likelihood of recurrence is very low (such as basal cell carcinoma), as judged by the medical monitor, are eligible for this study.
- Have evidence of interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).
- Have moderate or severe cardiovascular disease, such as the following:
- Have the presence of cardiac disease.
- Have valvulopathy that is severe, moderate, or deemed clinically significant.
- Have documented major electrocardiogram (ECG) abnormalities which are clinically significant.
- Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (patients receiving anticonvulsants are eligible).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Tennessee Oncology
Nashville, Tennessee, 37203
Oklahoma University
Oklahoma City, Oklahoma, 37104
About this study
Official title: A Tissue Collection Study to Explore the Correlation Between ATM Genetic Alterations by Next-Generation Sequencing and ATM Loss-of-Protein Via IHC (ATR-ID Study)
This study examines the correlation between ATM alterations identified using NGS profiles with ATM protein expression levels from tumor tissue assessed by IHC.
Read the detailed description
The purpose of this study is to address whether ATM genomic aberrations could be used to enrich for patients with ATM LoP. Screening of unselected patient populations for ATM protein loss is likely to a lead to high failure rate by IHC testing, as the prevalence of this is expected to be low. This study could allow for identification of the types of ATM aberrations that lead to ATM LoP, and thus significantly decrease IHC failure rate by pre-selecting patients harboring such aberrations. In this study the investigator will be collecting archival tumor tissue or fresh tissue which will be assessed for ATM LoP and compared to NGS data. Additionally, patients whose tumors exhibit ATM LoP within this study could potentially enroll onto the treatment study REFMAL 721/ART0380C001.
- Conditions
- Solid Tumor, Unspecified, Adult
- Being tested
- Determination of ATM alteration status.
- Keywords
- ATM, DDR, ATR, protein expression, LoF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of ATM alteration status.Other
ATM alterations identified using NGS profiles with ATM protein expression levels from tumor tissue assessed by IHC.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Deceased patients with archival tissue Receives: Other: Determination of ATM alteration status. | |
| Group B | Living patients with archival tissue Receives: Other: Determination of ATM alteration status. | |
| Group C | Living patients without archival tissue Receives: Other: Determination of ATM alteration status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with loss of ATM protein
ATM protein expression levels from tumor tissue assessed by immunohistochemistry (IHC)
Measured: 12 months
Secondary outcomes (3)
Number of potential patients with loss of ATM protein eligible for study REFMAL 721/ART0380C001
Patients in Group C are considered for enrolment into study REFMAL 721/ART0380C001 and must meet eligibility based on review of their medical records. REFMAL 721/ART0380C001 is a phase I/IIa open-label trial to assess the safety, tolerability, and preliminary efficacy of the ATR kinase inhibitor, ART0380 administered as a monotherapy as well as in drug combinations with gemcitabine in patients with advanced or metastatic solid tumors.
Measured: 12 months
Number of ATM genomic aberrations that lead to ATM LoP
Identify types of ATM protein expression from tumor tissue assessed by immunohistochemistry (IHC)
Measured: 12 months
Rate of loss of function (LoF) of the ATM gene in patients with genomic aberrations in the ATM gene
ATM alterations identified using Next-Generation Sequencing(NGS) profiles
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start28 May 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, Unspecified, AdultStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artios Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Johnson, MD, Study chair, Sarah Cannon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976803
- Sponsor's protocol ID
- ART0380C002
- Acronym
- ATM
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2021
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tissue Collection Study to Explore the Correlation Between ATM Genetic Alterations by Next-Generation Sequencing and ATM Loss-of-Protein Via IHC (ATR-ID Study)
- ClinicalTrials.gov ID
- NCT04976803
- Acronym / sponsor ID
- ATM / ART0380C002
- Conditions
- Solid Tumor, Unspecified, Adult
- Keywords
- ATM, DDR, ATR, protein expression, LoF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Artios Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 28 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 26 Jul 2021 (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 study examines the correlation between ATM alterations identified using NGS profiles with ATM protein expression levels from tumor tissue assessed by IHC.
Detailed description
The purpose of this study is to address whether ATM genomic aberrations could be used to enrich for patients with ATM LoP. Screening of unselected patient populations for ATM protein loss is likely to a lead to high failure rate by IHC testing, as the prevalence of this is expected to be low. This study could allow for identification of the types of ATM aberrations that lead to ATM LoP, and thus significantly decrease IHC failure rate by pre-selecting patients harboring such aberrations. In this study the investigator will be collecting archival tumor tissue or fresh tissue which will be assessed for ATM LoP and compared to NGS data. Additionally, patients whose tumors exhibit ATM LoP within this study could potentially enroll onto the treatment study REFMAL 721/ART0380C001.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Determination of ATM alteration status.Deceased patients with archival tissue |
| Group B | – | Other: Determination of ATM alteration status.Living patients with archival tissue |
| Group C | – | Other: Determination of ATM alteration status.Living patients without archival tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with identified ATM alterations will be potentially enrolled into this study in 1 of 3 patient populations * Group A: Deceased patients with archival tumor tissue * Group B: Living patients with archival tumor tissue * Group C: Living patients without archival tumor tissue
Key inclusion criteria (15 listed)
- Patients must meet the following criteria in order to be included in the research study:
- Previous genetic testing of ATM genomic aberrations.
- ≥18 years of age.
- Signed written informed consent to access archival tissue, if available.
- Provided signed written informed consent to collect a fresh core biopsy.
Key exclusion criteria (18 listed)
- There are no exclusion criteria for patients in Group A and Group B.
- Group C patients who meet any of the following criteria will be excluded from study entry:
- Have a significant bleeding disorder or vasculitis or had a Grade 3 bleeding episode within 12 weeks prior to enrollment.
- Presumed ineligible for enrollment to REFMAL 721/ART0380C001:
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 |
|---|---|---|
| Determination of ATM alteration status.ATM alterations identified using NGS profiles with ATM protein expression levels from tumor tissue assessed by IHC. | Other | Group A, Group B, Group C |
Primary outcome
Number of patients with loss of ATM protein
Time frame: 12 months
ATM protein expression levels from tumor tissue assessed by immunohistochemistry (IHC)
3 secondary outcomes
Number of potential patients with loss of ATM protein eligible for study REFMAL 721/ART0380C001
Time frame: 12 months
Number of ATM genomic aberrations that lead to ATM LoP
Time frame: 12 months
Rate of loss of function (LoF) of the ATM gene in patients with genomic aberrations in the ATM gene
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Melissa Johnson, MD study chair
Sarah Cannon
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, Unspecified, Adult, run by Artios Pharma Ltd at 3 sites in 2 countries.
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 15 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: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with loss of ATM protein (time frame: 12 months). 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 1 Aug 2022; AzTrials last refreshed its copy on 29 Oct 2026.