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Ref Type abstract
PMID
Authors W. Li, Z. Kang, S. Li, F. Chen, B. Zhang, M. Huang, Z. Yang, C. Chen, Z. Yang
Title 453MO A phase I study for safety, tolerability, pharmacokinetics, and anti-tumor activity of ABM-1310 in patients (pts) with BRAF V600 mutated recurrent primary brain tumours: Interim result
Journal Vol Issue Date Pages Journal Short Title
Annals of Oncology 35 Supplement 2 September 2024
URL https://www.annalsofoncology.org/article/S0923-7534(24)02042-8/fulltext
Abstract Text Background ABM-1310 is a high blood brain barrier penetrant BRAF inhibitor. Here we report the interim result from a phase I study of ABM-1310 in pts with recurrent primary brain tumors (Clinical trial information: NCT05892653). Methods This is an open-label, dose-escalation with cohort expansion study. In the dose-escalation part, pts received ABM-1310 at either 150 or 200mg bid. Dose-limiting toxicities (DLT) were assessed by a “3+3 design”. Primary objectives were maximum tolerated dose (MTD), safety and tolerability of ABM-1310. Secondary objectives included pharmacokinetics (PK) and anti-tumor activity. Results As of April 8, 2024, 15 pts (7 male; median age 39 years) have been treated. Eight received 150mg bid, 7 were on 200mg bid of ABM-1310. For safety, all pts experienced treatment-related adverse events (TRAEs). Two most common TRAEs were asymptomatic QT prolongation (n=11) and rash (n=8). Grade 1-2 TRAEs accounts for 88.7% of cases. Seven pts had Grade 3 ECG QT prolongation. There was only one pt who was in the 150mg bid dose group discontinued earlier due to asymptomatic Grade 3 QT prolongation. In the 200mg bid dose group, 3 pts each needed either treatment withholding or a dose reduction, respectively. There were no DLT events, no Grade 4 AE, no SAE and no treatment-related deaths. For anti-tumor activity, among 13 efficacy evaluable pts, 3 pts had partial response (PR, includes glioblastoma [GBM], WHO Grade 2 and 3 each of pleomorphic xanthoastrocytoma) and 8 pts had stable disease as their best response. Two pts maintained a PR response for > 8 months and continue study treatment to date. The MTD for ABM-1310 was 200mg bid. The regimen of ABM-1310 150mg bid was chosen for the expansion cohorts. Preliminary PK assessment of ABM-1310 blood exposure vs. dosage showed a linear dose-proportional relationship. The trial is ongoing. Conclusions ABM-1310 was generally tolerated without unknown safety signals. Preliminary anti-tumor activity was observed in pts with BRAF V600-mutated recurrent primary brain tumors.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF V600X brain cancer predicted - sensitive ABM-1310 Phase I Actionable In a Phase I trial, ABM-1310 treatment was well tolerated and resulted in preliminary antitumor activity with 3 partial responses and 8 stable disease among 13 patients with brain tumors harboring BRAF V600 mutations, including a partial response in a patient with glioblastoma and 2 partial responses in patients with pleomorphic xanthoastrocytoma (Ann Oncol (2024) 35 (suppl_2): S411; NCT05892653). detail...