Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT04976803
Eligibility Criteria:
Inclusion Criteria:
* 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:
1. Previous genetic testing of ATM genomic aberrations.
2. ≥18 years of age.
All living patients (Groups B and C) must also meet the additional criteria:
3. Signed written informed consent to access archival tissue, if available.
All Group C patients must also meet the additional criteria:
4. Provided signed written informed consent to collect a fresh core biopsy.
5. Have a non-irradiated, biopsiable tumor site to allow sampling for analysis via IHC for loss of ATM protein.
6. 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
Exclusion Criteria:
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:
1. Have a significant bleeding disorder or vasculitis or had a Grade 3 bleeding episode within 12 weeks prior to enrollment.
2. 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.
* 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:
1. One or more opportunistic HIV/AIDs-related infections within the past 12 months.
2. Documented active or chronic infection with hepatitis B virus (positive hepatitis B surface antigen \[+HBsAg\]), or hepatitis C virus.
3. Known history of clinical diagnosis of tuberculosis.
4. 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:
1. Have the presence of cardiac disease.
2. Have valvulopathy that is severe, moderate, or deemed clinically significant.
3. 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04976803
Study Brief:
Protocol Section:
NCT04976803