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.
12345Eligibility 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
+10 more
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
+16 more
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Cohort 1: ABN401Experimental Treatment1 Intervention
Subjects will receive ABN401 800 mg, monotherapy, administered orally once daily in 21-day cycles
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mid Florida CenterOrange City, FL
The University of Texas MD Anderson Cancer CenterHouston, TX
Cancer Care of North Florida, PA (Lake City Cancer Care, LLC) - Medical OncologyLake City, FL
The Henry Ford Cancer InstituteDetroit, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Abion IncLead Sponsor
References
Clinical features and outcomes of ALK rearranged non-small cell lung cancer with primary resistance to crizotinib. [2020]Crizotinib is associated with a favorable survival benefit in patients with ALK-positive non-small cell lung cancer (NSCLC); however, a subset of patients harboring ALK rearrangement shows a poor response.
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]Despite the poor prognosis associated with melanoma brain metastases (BM), data concerning these patients and their inclusion in clinical trials remains scarce. We report here the efficacy results of a subgroup analysis in patients with BRAFV600-mutant melanoma and BM treated with BRAF and MEK inhibitors dabrafenib (D) and trametinib (T).
Multikinase Inhibitor Crizotinib Is Active in MET Exon 14-Altered Lung Cancer. [2020]Crizotinib showed efficacy in non-small cell lung cancer (NSCLC) with alterations in MET exon 14.
Comparative efficacy of brigatinib versus ceritinib and alectinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small cell lung cancer. [2020]Brigatinib, ceritinib, and alectinib are approved to treat crizotinib-refractory anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC), but no trial has compared them head-to-head. A matching-adjusted indirect comparison (MAIC) was conducted to estimate the relative efficacy of these agents in the crizotinib-refractory setting.
Profound MEK inhibitor response in a cutaneous melanoma harboring a GOLGA4-RAF1 fusion. [2023]BRAF and CRAF are critical components of the MAPK signaling pathway which is activated in many cancer types. In approximately 1% of melanomas, BRAF or CRAF are activated through structural arrangements. We describe here a metastatic melanoma with a GOLGA4-RAF1 fusion and pathogenic variants in CTNNB1 and CDKN2A. Anti-CTLA4/anti-PD1 combination immunotherapy failed to control tumor progression. In the absence of other actionable variants the patient was administered MEK inhibitor therapy on the basis of its potential action against RAF1 fusions. This resulted in a profound and clinically significant response. We demonstrated that GOLGA4-RAF1 expression was associated with ERK activation, elevated expression of the RAS/RAF downstream co-effector ETV5, and a high Ki67 index. These findings provide a rationale for the dramatic response to targeted therapy. This study shows that thorough molecular characterization of treatment-resistant cancers can identify therapeutic targets and personalize management, leading to improved patient outcomes.