NCT05541822

A Phase 2 Multicenter, Open-Label, Parallel Cohort Expansion Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-Mesenchymal-epithelial Transition Factor (c-MET) Dysregulation

Recruiting now Phase 2 Last updated 16 May 2025

What this trial tests

Phase 2 trial testing Vabametkib in Advanced Solid Tumors in 178 participants. Currently enrolling.

Timeline

17 January 2023

Primary endpoint
1 February 2029

1 February 2029

Quick facts

Lead sponsor	Abion Inc
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	178
Start date	17 January 2023
Primary completion	1 February 2029
Estimated completion	1 February 2029
Sites	24 locations across United States, South Korea, Taiwan

Drugs / interventions tested

• Vabametkib — full drug profile →
• Lazertinib — full drug profile →

Conditions studied

• Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

Abion Inc — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Cohort 1: Objective response rate (ORR) according to response evaluation criteria in solid tumors (RECIST)1.1 by Blinded Independent Central Review (BICR)
  Time frame: Up to 12 months
  ORR is defined as the proportion of patients who experience a complete response (CR) or partial response (PR) as measured by RECIST 1.1
• Cohort 2 Part 1: Incidence of DLT (Dose Limiting Toxicity)
  Time frame: Up to 12 months
• Cohort 2 Part 2: Optimal dose of vabametkib and lazertinib combination for Part 3 based on the risk-benefit assessment considering both ORR (Objective Response Rate) and AE (Adverse Events)
  Time frame: Up to 12 months
• Cohort 2 Part 3: ORR (Objective Response Rate)
  Time frame: Up to 12 months

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The expanding role of the receptor tyrosine kinase MET as a therapeutic target in non-small cell lung cancer.
   Sattler M, Salgia R. · · 2025 · cited 11× · PMID 40020676 · DOI 10.1016/j.xcrm.2025.101983
2. Epithelial-Mesenchymal Transition in Cancer: Insights Into Therapeutic Targets and Clinical Implications.
   Srinivasan D, Balakrishnan R, Chauhan A, Kumar J, et al · · 2025 · cited 5× · PMID 40895189 · DOI 10.1002/mco2.70333
3. Recent advances in the treatment of non-small cell lung cancer with MET inhibitors.
   Zhang D, Zhang W, Liu H, Liu P, et al · · 2024 · cited 1× · PMID 39720556 · DOI 10.3389/fchem.2024.1501844
4. Synergistic Antitumor Activity of Combination Therapy with a MET TKI Vabametkib and a Third-Generation EGFR TKI Lazertinib in MET-Amplified EGFR-Mutant NSCLC.
   Kim DK, Park JW, Cho HB, Choi SJ, et al · · 2026 · PMID 41927036 · DOI 10.4143/crt.2025.1399
5. Partial-EMT in oral squamous cell carcinoma: molecular circuitry and clinical translation.
   Wang C, Sarubo M, Chen S, Kudo Y. · · 2026 · PMID 41611665 · DOI 10.1038/s41368-025-00417-0