BGB-B167 / BeOne Medicines - LARVOL DELTA

Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=55 | Terminated | Sponsor: BeiGene | Active, not recruiting ➔ Terminated; Sponsor decision

Trial termination • Oncology • Solid Tumor

First-in-human, phase 1a, dose escalation study of BGB-B167, a CEA x 4-1BB bispecific antibody, as monotherapy or combined with tislelizumab (anti-PD-1), in patients with selected advanced or metastatic solid tumors. (ASCO-GI 2025) - P1 | "Overall, BGB-B167 ± TIS was well tolerated and has demonstrated limited antitumor activity in pts with advanced/metastatic CEA+ solid tumors. Safety.Patients with multiple adverse events (AEs) are counted once. All AEs are listed as n (%)."

Clinical • Metastases • Monotherapy • P1 data • Gastrointestinal Cancer • Oncology • Solid Tumor • CD4 • CD8 • MSI

BGB-B167, a first-in-class 4-1BB (CD137)/ CEACAM5 bispecific antibody, exhibits potent in vitro and in vivo anti-tumor activity and superior safety profile in preclinical models (AACR 2024) - "Here, we describe the characterization of BGB-B167 with regard to preclinical proof-of-concept and basic drug-like properties. The combined dataset provides an overview on the design, mode of action, preclinical pharmacology and safety profile of BGB-B167."

Preclinical • Endocrine Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Thyroid Gland Carcinoma • CEACAM5 • TNFRSF9

Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=55 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting | Phase classification: P1a/1b ➔ P1 | N=254 ➔ 55 | Trial completion date: Aug 2025 ➔ Jan 2025

Combination therapy • Enrollment change • Enrollment closed • Metastases • Phase classification • Trial completion date • Oncology • Solid Tumor

Safety, Pharmacokinetics and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab in Participants With Solid Tumors in Chinese Participants (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: BeiGene | Phase classification: P1a/1b ➔ P1 | N=254 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Phase classification • Trial withdrawal • Oncology • Solid Tumor

Safety, Pharmacokinetics and Antitumor Activity of BGB-B167alone and in Combination With Tislelizumab in Participants With Solid Tumors in Chinese Participants (clinicaltrials.gov) - P1a/1b | N=254 | Not yet recruiting | Sponsor: BeiGene | Initiation date: Sep 2023 ➔ Mar 2024

Combination therapy • Metastases • Trial initiation date • Oncology • Solid Tumor

Safety, Pharmacokinetics and Antitumor Activity of BGB-B167alone and in Combination With Tislelizumab in Participants With Solid Tumors in Chinese Participants (clinicaltrials.gov) - P1a/1b | N=254 | Not yet recruiting | Sponsor: BeiGene | Initiation date: May 2023 ➔ Sep 2023

Combination therapy • Metastases • Trial initiation date • Oncology • Solid Tumor

Safety, Pharmacokinetics and Antitumor Activity of BGB-B167alone and in Combination With Tislelizumab in Participants With Solid Tumors in Chinese Participants (clinicaltrials.gov) - P1a/1b | N=254 | Not yet recruiting | Sponsor: BeiGene

Combination therapy • New P1 trial • Oncology • Solid Tumor

Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=254 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Oncology • Solid Tumor

Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=254 | Not yet recruiting | Sponsor: BeiGene

Combination therapy • New P1 trial • Oncology • Solid Tumor