To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer Harboring c-MET Dysregulation

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

November 30, 2023

Study Completion Date

January 3, 2024

Conditions
Advanced Solid Tumors
Interventions
DRUG

ABN401- Escalation Phase

Dose administration: Escalation Phase The regular dose levels of ABN401 will range from 50 mg to 1800 mg QD daily for 21 days.

DRUG

ABN401- Expansion Phase

"Dose administration: Expansion Phase The expansion phase of the study will use the dose and schedule determined to be most appropriate in the dose escalation portion of the study. This may be the MTD and/or the RP2D and will consist of cohorts of NSCLC patients with c-MET dysregulation.~Patients will receive ABN401 800 mg, administered orally once daily for 21 days until disease progression, unacceptable toxicity, or patient withdrawal."

Trial Locations (7)

2031

Scientia Clinical Research, Randwick

2170

Sydney Southwest Private Hospital, Liverpool

2217

ST George Private Hospital, Kogarah

6009

Linear Clinical Research, Perth

10408

National Cancer Centre, Goyang-si

03722

Yonsei University Health System, Severance, Seoul

05505

Asan Medical Centre, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Novotech (Australia) Pty Limited

INDUSTRY

lead

Abion Inc

INDUSTRY