BAY 3547926 / Bayer - LARVOL DELTA

Glypican-3 as a Theranostic Target in Hepatocellular Carcinoma. (PubMed, J Nucl Med) - "A clinical phase 1 trial with an 225Ac-labeled macrocyclic peptide ([225Ac]Ac-RAYZ-8009, RYZ801) using PET with [68Ga]Ga-RAYZ-8009 (RYZ811) for patient selection is currently ongoing. Furthermore, an 225Ac-labeled GPC3 antibody, BAY 3547926, is undergoing phase 1/2 clinical testing."

First-in-human • IO biomarker • Journal • Fibrosis • Hepatoblastoma • Hepatocellular Cancer • Immunology • Oncology • Solid Tumor • GPC3

BANTAM-01: A Multicenter, Open-Label, First-in-Human Phase 1 Dose Escalation and Expansion Study of 225Ac-GPC3 (BAY 3547926) in Patients with Advanced Hepatocellular Carcinoma. (PubMed, J Nucl Med) - " Study recruitment commenced in March 2025, and approximately 148 participants will be enrolled. The study will provide important preliminary insights on the efficacy and safety of 225Ac-GPC3 ACC therapy."

First-in-human • Journal • P1 data • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer (clinicaltrials.gov) - P1 | N=148 | Recruiting | Sponsor: Bayer | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

BANTAM-01: A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer (clinicaltrials.gov) - P1 | N=148 | Recruiting | Sponsor: Bayer | Trial completion date: Dec 2033 ➔ Aug 2031 | Trial primary completion date: Jul 2030 ➔ Jul 2029

First-in-human • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • GPC3

A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer (clinicaltrials.gov) - P1 | N=148 | Not yet recruiting | Sponsor: Bayer | Trial completion date: Feb 2029 ➔ Dec 2033 | Trial primary completion date: Nov 2027 ➔ Jul 2030

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

BAY 3547926: Novel targeted radionuclide therapy for hepatocellular carcinoma (AACR 2025) - P1 | "BANTAM-01 (NCT06764316) is a multicenter, open label, non-randomized study to evaluate the safety and tolerability, PK, and anti-tumor activity of 225Ac-GPC3 alone and in combination. The study is now active and enrolling GPC3 positive HCC patients."

First-in-human • IO biomarker • Hepatocellular Cancer • Oncology • Solid Tumor • AFP • GPC3

Bayer Initiates Phase I Study Targeting GPC3 With Actinium-225 Radiopharmaceutical in Patients With Advanced Hepatocellular Carcinoma (Businesswire) - "Bayer announced today initiation of a Phase I clinical trial with 225Ac-GPC3 (BAY 3547926), an investigational targeted alpha radiopharmaceutical being developed to treat tumors expressing Glypican-3 (GPC3) in patients with advanced hepatocellular carcinoma (HCC)....The first-in-human, dose escalation study (NCT06764316) will evaluate the safety, tolerability and preliminary efficacy of BAY 3547926 alone, and as a combination therapy in patients with advanced HCC."

Trial status • Hepatocellular Cancer