A phase 2 study of telisotuzumab adizutecan (ABBV-400; Temab-A) in patients with advanced solid tumors harboring <i>MET</i> amplification.

Abstract

TPS3157 Background: MET amplification is a rare alteration occurring at a rate of 0.06%–4.2%, in different solid tumor types across genomic databases. It is associated with poor prognosis and has limited treatment options. Currently, there are no therapies approved specifically to target MET -amplified tumors. Temab-A is an antibody-drug conjugate targeting c-Met and conjugated to a topoisomerase 1 inhibitor payload. In a first-in-human study (NCT05029882), Temab-A demonstrated encouraging activity (objective response rate 46%) and a manageable safety profile in MET -amplified solid tumors (Murciano-Goroff et al. ESMO 2025), supporting the continued investigation of Temab-A. The present phase 2 study evaluates Temab-A in adults and adolescents (12–17 years) with relapsed/refractory advanced solid tumors harboring MET amplification. Methods: This is an open-label, single-arm, global, multicenter phase 2 study (NCT07196644) enrolling approximately 125 patients (100 global; 25 China cohort) with locally advanced or metastatic solid tumors harboring MET amplification. Patients must have received ≥1 prior systemic therapy appropriate for their tumor type in the advanced/metastatic setting and have no satisfactory alternative treatment options. Patients must be ≥12 years old, have ECOG PS 0–1, measurable disease per RECIST v1.1 or RANO, and documented MET amplification by local next-generation sequencing or central FoundationOne CDx. Patients are treated with Temab-A 2.4 mg/kg IV every 3 weeks until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Trial objectives are listed in the table. Enrollment began in November 2025; as of December 2025, 1 patient has enrolled. Clinical trial information: EU CT: 2024-518871-74-00. Objectives. Primary Evaluate efficacy (ORR per ICR, RECIST v1.1/RANO) and safety of Temab-A (AEs, vital signs, ECG, clinical laboratory testing) Secondary Further assess efficacy (DOR, PFS, OS, disease control) and characterize PK and immunogenicity (PK parameters, ADAs, nADAs) Exploratory Biomarker analyses (eg, c-Met expression) and PROs evaluation ADAs, antidrug antibodies; AEs, adverse events; DOR, duration of response; ECG, electrocardiogram; ICR, independent central review; nADAs, neutralizing antidrug antibodies; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; PROs, patient-reported outcomes; RANO, Response Assessment in Neuro-Oncology; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1.