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ATRN-119 for Advanced Cancer
Phase 1 & 2
Recruiting
Led By Geoffrey Shapiro, MD, PhD
Research Sponsored by Atrin Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
DNA damage response (DDR) mutations documented in the past medical record or confirmed during the screening period
Subject must be capable of oral administration of study medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 56
Awards & highlights
Study Summary
This trial will study ATRN-119, a new drug for treating advanced solid tumors. The safety and effectiveness of ATRN-119 will be assessed in this open-label study.
Who is the study for?
This trial is for adults with advanced solid tumors who have specific DNA damage response mutations. They must be able to take pills, have a life expectancy of at least 3 months, and measurable disease by certain medical imaging criteria. People can't join if they've had recent surgery, are on strong CYP3A4 or CYP2D6 inhibitors/inducers, had leukemia in the last 5 years, unstable heart conditions, known HIV infection, uncontrolled high blood pressure, recent non-cancer related GI bleeding or therapy within 4 weeks.Check my eligibility
What is being tested?
The study tests ATRN-119's safety and effectiveness when taken orally by patients with advanced solid tumors. It's an open-label Phase 1/2a trial which means everyone knows what treatment they're getting and it combines initial testing (Phase 1) with early efficacy evaluation (Phase 2a).See study design
What are the potential side effects?
While the side effects of ATRN-119 aren't listed here specifically since this is an early-phase trial assessing safety and effectiveness; common side effects may include nausea, fatigue, allergic reactions or other drug-specific adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My records show I have DNA damage response mutations.
Select...
I can take pills by mouth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics
Trial Design
6Treatment groups
Experimental Treatment
Group I: 800mg ATRN-119Experimental Treatment1 Intervention
Once daily oral administration.
Group II: 550mg ATRN-119Experimental Treatment1 Intervention
Once daily oral administration.
Group III: 50mg ATRN-119Experimental Treatment1 Intervention
Once daily oral administration.
Group IV: 350mg ATRN-119Experimental Treatment1 Intervention
Once daily oral administration.
Group V: 200mg ATRN-119Experimental Treatment1 Intervention
Once daily oral administration.
Group VI: 100mg ATRN-119Experimental Treatment1 Intervention
Once daily oral administration.
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Who is running the clinical trial?
Atrin PharmaceuticalsLead Sponsor
Aprea TherapeuticsLead Sponsor
13 Previous Clinical Trials
789 Total Patients Enrolled
Geoffrey Shapiro, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
7 Previous Clinical Trials
212 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had chemotherapy, immunotherapy, radiotherapy, or targeted therapies in the last 4 weeks.I haven't had a heart attack or unstable chest pain in the last 6 months.My records show I have DNA damage response mutations.I haven't had GI bleeding or ulcers in the last 3 months.I have HIV.I was diagnosed with leukemia in the last 5 years.My brain scans show unstable cancer spread to the brain in the last month.I am not taking strong drugs that affect liver enzymes CYP3A4 and CYP2D6.I am not currently fighting an infection or taking antibiotics/antivirals.I've had radiotherapy on the cancer spot unless it's gotten worse.My blood pressure is not controlled with medication.I had surgery within the last week before starting ATRN-119.I can take pills by mouth.
Research Study Groups:
This trial has the following groups:- Group 1: 50mg ATRN-119
- Group 2: 100mg ATRN-119
- Group 3: 200mg ATRN-119
- Group 4: 350mg ATRN-119
- Group 5: 550mg ATRN-119
- Group 6: 800mg ATRN-119
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been accepted into the cohort of this clinical trial?
"Affirmative. According to the information published on clinicaltrials.gov, this research endeavor is actively seeking participants. It was initially posted in September 1st 2022 and has been recently updated on September 22nd of the same year. 45 individuals are required at two distinct locations for enrollment in the trial."
Answered by AI
Is the participant recruitment period for this research project still ongoing?
"Affirmative, the clinicaltrials.gov website confirms that this trial is actively seeking enrollees. It was first introduced on September 1st 2022 and last updated a few weeks later; 45 patients are required from two different medical centres."
Answered by AI
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