ABN401 for Solid Tumors

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Abion Inc

Must not be taking: Corticosteroids, PPI, CYP3A4 inhibitors

Disqualifiers: Liver disease, Lung disease, CNS tumor, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing ABN401, a new drug, in patients with advanced cancers that have a specific genetic change. The drug works by blocking a protein that helps cancer cells grow, aiming to stop or slow down the cancer.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as strong and moderate inhibitors/inducers of P-glycoprotein and CYP3A4, proton pump inhibitors, and systemic corticosteroids over 10 mg/day prednisone or equivalent, at least 1 week before starting the study. If you are on these medications and cannot stop them, you may not be eligible to participate.

What data supports the effectiveness of the drug ABN401 for solid tumors?

The research shows that drugs similar to ABN401, like crizotinib, have been effective in treating certain types of lung cancer with specific genetic changes. Additionally, MEK inhibitors, which are similar to one of the components in the treatment, have shown significant responses in certain types of melanoma, suggesting potential effectiveness in targeting specific cancer pathways. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Have a life expectancy of at least 3 months

If not menopausal or surgically sterile, willing to practice at least one of the following highly effective methods of birth control

ALL subjects must undergo blood sample for biomarker assessment

Exclusion Criteria

Patients with a corrected QT interval (QTcF) of > 470 msec (females) and > 450 msec (males)

I am currently being treated for an infection.

Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABN401 800 mg, monotherapy, administered orally once daily in 21-day cycles

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ABN401 (Small Molecule Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Cohort 1: ABN401 Experimental Treatment 1 Intervention

Subjects will receive ABN401 800 mg, monotherapy, administered orally once daily in 21-day cycles

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mid Florida Center Orange City, FL

The University of Texas MD Anderson Cancer Center Houston, TX

Cancer Care of North Florida, PA (Lake City Cancer Care, LLC) - Medical Oncology Lake City, FL

The Henry Ford Cancer Institute Detroit, MI

More Trial Locations

Who Is Running the Clinical Trial?

Abion Inc

Lead Sponsor

Trials

3

Patients Recruited

90+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical features and outcomes of ALK rearranged non-small cell lung cancer with primary resistance to crizotinib. Ma, D., Zhang, Y., Xing, P., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open label, non-randomised, phase IIIb study of trametinib in combination with dabrafenib in patients with unresectable (stage III) or distant metastatic (stage IV) BRAF V600-mutant melanoma: A subgroup analysis of patients with brain metastases. Dutriaux, C., Robert, C., Grob, JJ., et al.[2022]

Crizotinib has demonstrated effectiveness in treating non-small cell lung cancer (NSCLC) specifically in patients with alterations in the MET exon 14, indicating its targeted therapeutic potential.

This finding highlights the importance of genetic testing in NSCLC to identify patients who may benefit from crizotinib treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multikinase Inhibitor Crizotinib Is Active in MET Exon 14-Altered Lung Cancer. [2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of brigatinib versus ceritinib and alectinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small cell lung cancer. Reckamp, K., Lin, HM., Huang, J., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profound MEK inhibitor response in a cutaneous melanoma harboring a GOLGA4-RAF1 fusion. McEvoy, CR., Xu, H., Smith, K., et al.[2023]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Clinical features and outcomes of ALK rearranged non-small cell lung cancer with primary resistance to crizotinib. [2020]

2. England pubmed.ncbi.nlm.nih.gov

An open label, non-randomised, phase IIIb study of trametinib in combination with dabrafenib in patients with unresectable (stage III) or distant metastatic (stage IV) BRAF V600-mutant melanoma: A subgroup analysis of patients with brain metastases. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Multikinase Inhibitor Crizotinib Is Active in MET Exon 14-Altered Lung Cancer. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy of brigatinib versus ceritinib and alectinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small cell lung cancer. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Profound MEK inhibitor response in a cutaneous melanoma harboring a GOLGA4-RAF1 fusion. [2023]