Cohort 1: ABN401 for Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Advanced Solid TumorsABN401 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

ABN401-003 is a Phase 2 clinical study to assess efficacy, safety, tolerability and pharmacokinetic profile of ABN401 in specific populations of advance solid tumors with c-MET alterations as monotherapy.

Eligible Conditions
  • Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

10 Primary · 5 Secondary · Reporting Duration: Up to 12 months

Day 21
Pharmacokinetic (PK) parameter from plasma ABN401 concentration - AUC0-12: area under the concentration-time curve from time zero to 12 hr post-dose
Pharmacokinetic (PK) parameter from plasma ABN401 concentration - AUC0-24: area under the concentration-time curve from time zero to 24 hr post-dose
Pharmacokinetic (PK) parameter from plasma ABN401 concentration - AUC0-t: area under the concentration-time curve from time zero to the last measurable concentration
Pharmacokinetic (PK) parameter from plasma ABN401 concentration - AUC0-∞: area under the concentration-time curve from time zero extrapolated to infinity
Pharmacokinetic (PK) parameter from plasma ABN401 concentration - Cmax: Maximum concentration
Pharmacokinetic (PK) parameter from plasma ABN401 concentration - Ke: apparent first-order terminal elimination rate constant
Pharmacokinetic (PK) parameter from plasma ABN401 concentration - T1/2: apparent first-order terminal elimination half-life
Pharmacokinetic (PK) parameter from plasma ABN401 concentration - Tmax: Time to reach maximum concentration
Up to 12 months
Duration of response (DoR) as measured by RECIST 1.1
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)
Objective response rate (ORR) measured by RECIST 1.1 by investigator
Overall survival (OS)
Progression-free survival (PFS) according to RECIST 1.1
Week 12
Disease advanced control rate (DCR) as measured per RECIST 1.1

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
M1774
1
Dose Expansion Phase: JZP341
1
hSTC810

Trial Design

1 Treatment Group

Cohort 1: ABN401
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Cohort 1: ABN401 · No Placebo Group · Phase 2

Cohort 1: ABN401
Drug
Experimental Group · 1 Intervention: ABN401 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

Abion IncLead Sponsor
2 Previous Clinical Trials
102 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically or cytologically confirmed non-small cell lung cancer, advanced, recurrent, or metastatic.
You have sexual intercourse with a vasectomized male/sterilized female partner.
You are at least 18 years of age or designated age of majority.
You have at least one measurable lesion per RECIST 1.1, with the exception of bone-only disease (i.e., non-measurable disease per RECIST 1.
Barrier type devices used only in combination with a spermicide.
References

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