Amgen Initiates First-in-Class Phase I Clinical Trial of CDH3/MSLN Bispecific Antibody AMG 305 in Advanced Solid Tumors

On April 6, Amgen registered a Phase I clinical trial on the ClinicalTrials.gov website aimed at ① evaluating the safety, tolerability, and pharmacokinetics of AMG 305 in adult subjects with advanced solid tumors; ② determining the Optimal Biological Dose (OBD) and Maximum Tolerated Dose (MTD); ③ determining the recommended Phase II dose (RP2D).

AMG 305 is a bispecific antibody developed by Amgen based on its proprietary Bispecific T-cell Engager (BiTE) molecular technology platform, targeting cadherin-3 (CDH3) and mesothelin (MSLN).It is also the world's first CDH3/MSLN bispecific antibody.Blinatumomab, tarlatamab, acapatamab and other bispecific antibody drugs are also developed by Amgen based on the BiTE molecular technology platform. Amgen will disclose partial information about AMG 305 at AACR 2023.

This study is an open-label, non-randomized clinical trial, planning to enroll 260 subjects, with an expected start date of June 15, 2023, and completion by October 11, 2026. The study will be divided into Part A and Part B, with Part A being a dose-escalation study and Part B a dose-expansion study. Subjects in Part B will receive treatment at the RP2D determined in Part A.

Since AMG 305 is a CDH3 and MSLN-targeted drug, Amgen has restricted the enrollment criteria to solid tumor participants whose CDH3 and MSLN expression at the histological or cytological level must be confirmed by mRNA through the Cancer Genome Atlas (TCGA) database.

The primary endpoints of the study were the proportion of subjects experiencing dose-limiting toxicity (DLT), the proportion of subjects experiencing treatment-emergent adverse events (TEAEs), and the proportion of subjects experiencing treatment-related adverse events (TRAEs). Secondary endpoints included efficacy measures such as objective response rate (ORR) and duration of response (DOR), as well as some pharmacokinetic parameters.

CDH3 is a novel target with currently limited progress, and there are only five CDH3-targeted drugs in clinical research globally. MSLN has seen relatively more advancement, with 49 products entering clinical stages, although the majority are CAR-T cell therapies (59%, 35/49).

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