A Study of ATRN-119 In Patients With Advanced Solid Tumors (ATRN)

Brief description of study

The study will evaluate the safety profile of escalating doses of continuous daily oral ATRN-119 and to determine the maximum tolerated dose (MTD) and recommended dose. ATRN-119 is a drug that has been developed to treat cancers by taking advantage of genetic mutations found only in the tumor and not in normal tissue.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Advanced Solid Tumors including ovarian, endometrial and cervical cancer
Age: 18 Years
Gender: All

Inclusion Criteria:

DNA damage response (DDR) mutations documented in the past medical record or confirmed during the screening period.
Measurable disease defined by RECIST 1.1.
Life expectancy ≥ 3 months.
Subject must be capable of oral administration of study medication.

Exclusion Criteria:

Subject has had a cytotoxic chemotherapy, immunotherapy, radiotherapy or other targeted therapies within 4 weeks.
Surgical procedure performed within 7 days prior to first scheduled dose of ATRN-119.
Concomitant treatment with strong inhibitors or inducers of CYP3A4 and CYP2D6.
Known human immunodeficiency virus infection (HIV).
Subjects with active viral or bacterial infections and/or receiving systemic antibiotics or anti-viral medications.
Current or past diagnosis of leukemia within the past 5 years.
Prior radiotherapy at the target lesion unless there is evidence of disease progression.
Known CNS metastases or clinical evidence of CNS involvement that is not stable for previous 1 month by radiology documentation (magnetic resonance imaging [MRI] brain).
History of non-malignant gastronintestinal (GI) bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months.
Patient has uncontrolled hypertension at time of enrollment.
Complete left bundle branch block (LBBB), bifascicular block (right bundle branch block [RBBB] with either left anterior hemiblock or left posterior hemiblock).
Any clinically significant ST segment and/or T-wave abnormalities.
Myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication.

Updated on 11 Apr 2024. Study ID: 849959

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