BGB-R046 / BeOne Medicines - LARVOL DELTA

BGB-R046-101: A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=42 | Terminated | Sponsor: BeOne Medicines | N=75 ➔ 42 | Trial completion date: Dec 2027 ➔ Apr 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2027 ➔ Apr 2026; This decision is due to a company business decision with a strategy change on the BGB-R046 development in Advanced or Metastatic Solid Tumors.

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

BGB-R046, an IL-15 pro-drug demonstrates robust pharmacodynamic effects and immune activation within tumor microenvironment in a mouse syngeneic model (AACR 2025) - P1 | "BGB-R046 is an IL-15 prodrug with minimum free drug release in the peripheral and induced robust pharmacodynamic effects and immune activation within tumor microenvironment in the MC38 mouse syngeneic model. A clinical study evaluating BGB-R046 as monotherapy and in combination with tislelizumab (anti-PD-1 antibody) in patients with advanced or metastatic tumors is ongoing(NCT06487858)."

IO biomarker • PK/PD data • Preclinical • Tumor microenvironment • Oncology • CD8 • IL15 • STAT5

BGB-R046-101: A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=75 | Active, not recruiting | Sponsor: BeOne Medicines | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Monotherapy • Oncology • Solid Tumor

Discovery of BGB-R046, an IL-15 pro-drug that is conditionally activated by proteases in the tumor microenvironment for the treatment of cancer (SITC 2024) - "Conclusions BGB-R046, an IL-15 pro-drug, demonstrated remarkable in vitro masking capability, significant anti-tumor efficacy in mouse model, favorable PK and safety profile in cyno monkeys. First-in-human study was initiated in 2024Q3 to investigate the BGB-R046 as monotherapy and in combination with tislelizumab (anti-PD-1 therapy) in patients with advanced tumors."

Biomarker • Tumor microenvironment • Oncology • CD8 • IL15

BGB-R046-101: A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=74 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

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

BGB-R046-101: A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=74 | Not yet recruiting | Sponsor: BeiGene

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