A Phase 1/2a Open-Label Safety Pharmacokinetic and Preliminary Efficacy Trial of Oral ATRN-119 in Patients with Advanced Solid Tumors (AR-276-01)
Recruiting
99 years or below
All
Phase
1
10 participants needed
1 Location
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. ATR (Ataxia Telangiectasia and Rad3-related kinase) is an enzyme that is involved in report of DNA damage in cells, including cancer cells. ATR is most effective against cancers that have some DNA damage or cannot repair damaged DNA. The field of DNA Damage and Response (DDR) is a new focus for treating cancer over the past decade. ATR is one enzyme that regulates DDR. ATRN-119 inhibits the function of ATR and helps prevent cancer cells from repairing DNA damage leading to selective killing of the cancer cell. Therefore, ATRN-119 is being explored as a potential new method of treating cancer both by itself (monotherapy) as well as in combination with other medications. The primary objectives of this study are to evaluate the safety profile of escalating doses of daily oral ATRN-119 and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) as well as to characterize the PK profile of oral ATRN-119 and its active metabolite ATRN-157. Endpoints: Adverse events (AEs), dose limiting toxicities (DLTs), changes in physical examinations, vital signs, Eastern
Cooperative Oncology Group Performance Scale (ECOG PS), electrocardiograms (ECGs), and clinical laboratory values including PK analysis. The secondary objective is to evaluate antitumor activity of oral ATRN-119 in various solid tumors. Endpoints: Biomarkers and Response Evaluation, Criteria in Solid Tumors (RECIST) (version 1.1)
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 99 years or below
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Gender: All
Updated on
04 Aug 2024.
Study ID: 849959