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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial tests a new drug to treat advanced solid tumors with c-MET changes. It looks at safety, effectiveness, and how the body handles it.
Who is the study for?
Adults with advanced solid tumors showing c-MET dysregulation, who have an ECOG performance status of 0 or 1 and a life expectancy of at least 3 months. They must have adequate organ function, agree to use effective birth control, and can't be on certain medications that affect ABN401 absorption or processing. Patients should not have had more than two prior cancer treatments and must not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing the drug ABN401's effectiveness, safety, tolerability, and how it's processed in the body when given alone to patients with specific types of advanced solid tumors that have changes in a gene called c-MET.See study design
What are the potential side effects?
While specific side effects for ABN401 are not listed here, common side effects from drugs targeting similar pathways include fatigue, nausea, vomiting, diarrhea and potential liver toxicity. Side effects may vary based on individual patient health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of ABN401 adverse events (AEs)
Objective response rate (ORR) according to response evaluation criteria in solid tumors (RECIST)1.1 by imaging central review (ICR)
Pharmacokinetic (PK) parameter from plasma ABN401 concentration - AUC0-12: area under the concentration-time curve from time zero to 12 hr post-dose
+7 moreSecondary outcome measures
Disease advanced control rate (DCR) as measured per RECIST 1.1
Duration of response (DoR) as measured by RECIST 1.1
Objective response rate (ORR) measured by RECIST 1.1 by investigator
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Cohort 1: ABN401Experimental Treatment1 Intervention
Subjects will receive ABN401 800 mg, monotherapy, administered orally once daily in 21-day cycles
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Who is running the clinical trial?
Abion IncLead Sponsor
2 Previous Clinical Trials
103 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for an infection.I have or had lung scarring or inflammation.I have had an organ or stem cell transplant.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is suspected to have a specific genetic change known as MET exon 14 skipping.I have at least one tumor that can be measured by scans, excluding bone-only cancer.I am willing to provide a new biopsy or have existing tumor tissue samples.My lung cancer is advanced, recurrent, or has spread to other parts.I haven't had or been treated for any cancer other than the one I'm seeking treatment for in the last 3 years.My organ functions are within normal ranges according to recent tests.I do not have an active infection with HIV, HTLV-1, HBV, or HCV.I am 18 years old or older, or at the age of majority in my country.I have a stomach or intestine problem that affects how my body absorbs medicine.My cancer has specific genetic changes that could be treated with targeted therapy.I have not been treated with c-MET inhibitors or HGF-targeting therapy.I don't have any health conditions that could affect the study or increase my risk.I have fluid in my abdomen or chest but have been stable for 2 weeks after treatment.I have a brain tumor or cancer spread to my brain or its coverings.My side effects from previous treatments are mild and haven't needed treatment for 2 weeks.I have a long-term liver inflammation.I haven't taken high doses of steroids or immunosuppressants in the last 30 days.I cannot stop my current medications for a week to start a new treatment.I have not had more than 2 treatments for my cancer and have either refused, not tolerated, or progressed after standard care.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: ABN401
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.
Has the ABN401 medication received formal endorsement from the FDA?
"As Cohort 1: ABN401 is currently in its second phase of clinical trials, it has achieved a safety rating of 2 due to the available evidence that supports its security but not yet any efficacy."
Answered by AI
How many people have been selected to participate in this medical experiment?
"Affirmative. Evidence posted on clinicaltrials.gov implies that this experiment is still enrolling participants, with applications being accepted at two locations for a total of 40 people. This trial was first established on January 17th 2023 and last edited 12 days later."
Answered by AI
Is the patient enrollment period of this experiment currently active?
"Affirmative. Clinicaltrials.gov records demonstrate that this medical study, initiated on January 17th 2023, is actively recruiting patients. 40 individuals are needed from 2 different clinical sites."
Answered by AI
What aims is this experiment seeking to accomplish?
"The primary outcome being monitored throughout the duration of this trial, as provided by Abion Inc., is Objective Response Rate (ORR) assessed via imaging central review per RECIST 1.1 criteria across Cycle 1: Day 1, Day 2, Day 15 and 16 pre-dose. In addition to ORR the research team will also be evaluating Disease Advanced Control Rate (DCR), Investigator-assessed ORR, and Progression-free Survival (PFS)."
Answered by AI
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