BGB-B3227 / BeOne Medicines - LARVOL DELTA

Preclinical characterization of BGB-B3227, a MUC1 x CD16A bispecific engager, for the treatment of MUC1-expressing solid tumors (AACR 2025) - P1 | "BGB-B3227 is a bispecific MUC1xCD16A NK engager demonstrating potent ADCC and ADCP activity, along with notable in-vivo anti-tumor efficacy when used as a monotherapy or in combination with anti-PD-1 therapy. BGB-B3227 represents a promise therapeutic option for MUC1-expressing cancers, with the potential to overcome the limitations of MUC1-N antibodies by mitigating the sink effect from soluble MUC1. Currently, BGB-B3227 alone and in combination with Tislelizumab is under clinical investigation in participants with advanced or metastatic solid tumors (NCT06540066)."

Bispecific • Preclinical • Colon Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • FCGR3A • MUC1

BGB-B3227-101: A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=35 | Terminated | Sponsor: BeiGene | N=75 ➔ 35 | Trial completion date: Jan 2027 ➔ Dec 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jan 2027 ➔ Dec 2025; Sponsor Decision

Enrollment change • First-in-human • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

BeiGene’s new Class 1 anti-tumor drug has been approved for clinical trials in the country! [Google translation] (bydrug.pharmcube.com) - "On October 22, according to the official website of CDE, BeiGene's Class 1 new drug BGB-B3227 for injection was approved for clinical trials, with the indication of advanced or metastatic solid tumors. As an innovative anti-tumor drug of BeiGene, BGB-B3227 was registered on the clinicaltrials website as early as August this year. Its clinical trial (NCT06540066) aims to explore the efficacy of BGB-B3227 alone and in combination with the PD-1 inhibitor tislelizumab in the treatment of advanced or metastatic solid tumors. The approval of clinical trials in China this time marks a new breakthrough for BeiGene in its innovative early molecular pipeline for solid tumors."

Trial status • Oncology • Solid Tumor

A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Oncology • Solid Tumor

A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=75 | Not yet recruiting | Sponsor: BeiGene

Combination therapy • Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor