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}

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

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] 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.

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] 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).

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

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.

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] 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.

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

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.