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NeoplasmsPhase 2NCT05882292

c-MET Inhibitor in Advanced Solid Tumors With c-MET Gene Aberration

A Phase 2 study testing ABN401 in people with Neoplasms, run by Yonsei University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

c-MET is a member of the receptor tyrosine kinase (RTK) family. Essential components of signal transduction pathways regulating processes including cell proliferation, differentiation, migration, metabolism, and cell cycle control, RTKs are established targets as treatment strategies for various cancers. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Neoplasms
What is being tested?
ABN401
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSouth Korea
Study dates
10 Nov 2023to 31 Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent for KOSMOS-II master observation study
  • Male or female ≥19 years of age
  • Histologically confirmed advanced solid cancers who harboring c-MET alterations (patients who performed NGS tests and c-MET alterations confirmed in molecular tumor board [MTB]) - exon 14 skipping mutation except for non-small cell lung cancer (NSCLC)
  • c-MET amplification GCN (gene copy no.) ≥6 by NGS
  • Fluorescence/Silver In situ hybridization (FISH/SISH) result of the MET/CEP7 ratio ≥2
  • Other MET alterations that are regarded to be actionable by the KOSMOS MTB
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  • Disease progression during or after standard therapy and without further treatment options, or no standard therapy, or ineligible for standard therapy
  • At least one measurable or evaluable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group Performance Status 0-2
  • Capable to eat food
  • Adequate organ functions
  • Absolute neutrophil count (ANC) ≥1500/mm3 (ie, 1.5×109/L by International - Unit [IU]); excluding measurements obtained within 7 days after administration of granulocyte colony stimulating factor (G-CSF)
  • Platelet count ≥75000/mm3 (IU: ≥75×109/L); excluding measurements obtained within 7 days after transfusion of platelets.
  • Hemoglobin value of ≥8.0 g/dL
  • AST/ALT ≤3×upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST / ALT ≤5×ULN
  • Total serum bilirubin of ≤1.5×ULN
  • Creatinine clearance (CrCl) of ≥50 mL/min (MDRD)
  • Have a life expectancy of at least 90 days
  • If not menopausal or surgically sterile, willing to practice at least one of the following highly effective methods of birth control for at least a (partner's) menstrual cycle before and for 3 months after study drug administration:
  • Barrier type devices (examples are condom, diaphragm, and contraceptive sponge) used only in combination with a spermicide
  • Sexual intercourse with vasectomized male/sterilized female partner
  • Hormonal female contraceptive (oral, parenteral, intravaginal, implantable, or transdermal) for at least 3 consecutive months prior to investigational product administration (when not clinically contraindicated as in breast, ovarian and endometrial cancers)
  • Use of an intrauterine contraceptive device
  • Note: Abstinence, the rhythm method, and/or contraception by the partner are not acceptable methods of birth control
  • Willing to provide available tissue specimens and consent to blood collection for evaluation of biomarkers
  • Archival tissue specimens: formalin-fixed, paraffin-embedded tissues
  • Optional fresh tissue collection prior to ABN401 administration

Who cannot join

  • Previous treatment with c-MET inhibitor
  • NSCLC with c-MET exon 14 skipping mutation
  • Previous hypersensitivity reaction to any component of study drugs
  • Presence or history of arrhythmia
  • Past history of
  • ① Major surgery within 4 weeks before study (must have complete recovery from surgical complications)
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  • ② Radiotherapy within 4 weeks before study or limited radiotherapy within 2 weeks
  • ③ Chemotherapy or biologic agents within 3 weeks before study (targeted therapy within 2 weeks and mitomycin within 5 weeks)
  • History of the following medical conditions
  • Active central nervous system (CNS) metastasis (clinically unstable after stopping steroid for more than 2 months)
  • Leptomeningeal metastasis
  • Acute systemic infection
  • Acute myocardial infarction, stable/unstable angina, symptomatic heart failure ((New York Heart Association [NYHA] class III or IV within the previous 6 months; if >6 months cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms)
  • Clinically critical chronic vomiting or diarrhea
  • Uncontrolled hypertension (systolic blood pressure >150mmHg diastolic blood pressure>100mmHg)
  • Proteinuria (urine dipstick or 24-hour urine collection > 1.0g): must have 24-hour urine collection if baseline urine dipstick ≥2+
  • Active HBV/ HCV except for
  • HBsAg (+) with undetectable HBV DNA
  • If HBsAg (+) and HBV DNA (+), chronic state of infection and clinically stable after anti-viral therapy for more than 3 months
  • If IgG anti-HBc (+) and past history of HBV infection, undetectable HBV DNA
  • HCV Ab (+) with undetectable HCV RNA
  • Severe psychiatric disorders
  • Concurrent anticoagulants at therapeutic dose
  • Past history of gastrointestinal perforation or fistula within 3 months before study, grade 3 or 4 of gastrointestinal bleeding/varix
  • Toxicity with prior therapy (> grade 1) (except for alopecia, pigmentation, poor oral intake), and neuropathy (> grade 1)
  • Pregnant or breastfeeding
  • Patients with a corrected QT interval (using Fridericia's correction formula) (QTcF) of > 470 msec

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

minkyu Jung contact

0222278406

minkjung@yuhs.ac

South Korea1 site, 1 recruiting

  • minkyu Jung

    Seoul, Seoul, 03722

    minkyu Jung, 0222278406, minkjung@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase II Study of ABN401 in Advanced Solid Tumors With c-MET Gene Aberration

c-MET is a member of the receptor tyrosine kinase (RTK) family. Essential components of signal transduction pathways regulating processes including cell proliferation, differentiation, migration, metabolism, and cell cycle control, RTKs are established targets as treatment strategies for various cancers. c-MET is expressed mainly in epithelial tissues and is subject to dysregulation manifesting as mutations, amplifications, and overexpression. c-MET is implicated in both primary oncogenesis, metastasis and also as a mechanism of drug resistance. c-MET has a high affinity for its naturally occurring ligand, Hepatocyte Growth Factor (HGF, also known as Scatter Factor). Binding of HGF to c-MET induces several complex signaling pathways, resulting in cell proliferation, survival, motility, induction of cells polarity, scattering, angiogenesis, and invasion. c-MET alterations are identified in various cancers.

Several drugs targeting c-MET inhibition have been developed, and capmatinib was approved by FDA in patients with non-small cell lung cancer harboring MET exon 14 skipping mutation. ABN401 competitively attaches to the ATP binding sites in the kinase domain of c-MET with high specificity to inhibit phosphorylation of downstream signaling pathways. Following several animal studies of advanced solid cancers, the first-in-human trial of ABN401 showed anti-tumor activity without DLT, and the phase 2 trial is ongoing.

Read more

Recently, the basket trials have been emphasized for tissue agnostic approach targeting certain genetic alterations, and the NCI-MATCH (National Cancer Institute-MATCH) trials in 3,000 patients with advanced solid cancers are ongoing.

Similarly, the KOSMOS-II study is ongoing in Korea. This study is the basket trial that Next-generation sequencing (NGS)-based genetic alterations, which is confirmed in Molecular Tumor Board (MTB), provide the individual treatment approach.

Read the detailed description

Α. Dose and cycle

  • ABN401 800 mg will be administered orally once daily immediately after a meal [should be within 1 hour post-meal (fed state)] at approximately the same time each day in a 21-day cycle.

Β. Treatment duration

  • ABN401 will be administered until disease progression, unacceptable toxicity, death, and consent withdrawal.
  • Step I: enrolled 8 patients will receive ABN401
  • Step II: if more than 3 out of 8 patients showed disease control (complete response, partial response, and stable disease), step II will be forwarded and additional 10 patients will be enrolled.
  • If more than 7 out of 18 patients showed disease control, ABN401 will be considered an effective drug in this study.
Conditions
Neoplasms
Being tested
ABN401
Keywords
ABN401, c-MET gene aberration, solid tumors
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABN401Drug

    Also called c-MET inhibitor

    ABN401 800 mg will be administered orally once daily immediately after a meal [should be within 1 hour post-meal (fed state)] at approximately the same time each day in a 21-day cycle.

Study groups in NCT05882292
Study groupRoleWhat they receive
ABN401ExperimentalABN401 800 mg will be administered orally once daily immediately after a meal [should be within 1 hour post-meal (fed state)] at approximately the same time each day in a 21-day cycle.
Receives: Drug: ABN401

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate (DCR) at 16 weeks

    Disease control rate (DCR) at 16 weeks

    Measured: Disease control rate (DCR) at 16 weeks

Secondary outcomes (4)

  1. Overall survival (OS)

    Overall survival (OS)

    Measured: 1 year

  2. Progression-free survival (PFS)

    Progression-free survival (PFS)

    Measured: at 16 weeks

  3. Objective response rate (ORR)

    Objective response rate (ORR)

    Measured: at 16 weeks

  4. Duration of response (DoR)

    Duration of response (DoR)

    Measured: at 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2023
  2. Study start10 Nov 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
ABN401
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05882292
Sponsor's protocol ID
4-2023-0093
Status last verified
Dec 2024
First submitted
11 May 2023
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABN401 in people with Neoplasms, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact minkyu Jung (0222278406, minkjung@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (DCR) at 16 weeks (time frame: Disease control rate (DCR) at 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05882292.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.

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