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Small Molecule Inhibitor

ABN401 for Solid Tumors

Phase 2
Recruiting
Research Sponsored by Abion Inc
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

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 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

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 blinded independent central review (BICR)
Pharmacokinetic (PK) parameter from plasma ABN401 concentration - AUC0-12: area under the concentration-time curve from time zero to 12 hr post-dose
+7 more
Secondary 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 more

Trial 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

Find a Location

Who is running the clinical trial?

Abion IncLead Sponsor
2 Previous Clinical Trials
103 Total Patients Enrolled

Media Library

ABN401 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05541822 — Phase 2
Solid Tumors Research Study Groups: Cohort 1: ABN401
Solid Tumors Clinical Trial 2023: ABN401 Highlights & Side Effects. Trial Name: NCT05541822 — Phase 2
ABN401 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05541822 — Phase 2
~12 spots leftby Apr 2025