BGB-A3055 / BeOne Medicines - LARVOL DELTA

BGB-A3055 Alone and in Combination With Tislelizumab in Participants With Solid Tumors (clinicaltrials.gov) - P1 | N=99 | Terminated | Sponsor: BeiGene | Recruiting ➔ Terminated; This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the CCR8 program.

IO biomarker • Trial termination • Oncology • Solid Tumor • CCR8 • PD-L1

A phase 1 study of BGB-A3055 (anti-CCR8) with or without tislelizumab (anti–PD-1) in patients with solid tumors. (ASCO 2026) - P1 | "BGB-A3055 ± TIS demonstrated a safety profile consistent with selective CCR8 on-target effects in pts with advanced solid tumors and had preliminary antitumor activity."

Clinical • IO biomarker • P1 data • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Hepatology • Immunology • Nephrology • Oncology • Renal Disease • Solid Tumor • AVEN • CCR8

BeOne shelves 5 cancer programs… (FierceBiotech) - "Four of the five cancer assets have been discontinued entirely, BeOne announced in its May 6 earnings presentation (PDF). These are the EGFR-targeting BG-60366, which was in development for lung cancer; a pan-KRAS inhibitor called BGB-53038 for lung and gastrointestinal tumors; MAT2A inhibitor BG-89894 for lung and solid tumors; and CDK2 inhibitor BG-68501, for breast and solid tumors....A study of the CCR8 antibody BGB-A3055 in solid tumors has also been terminated, but this asset has not been fully discontinued, a BeOne spokesperson confirmed to Fierce Biotech."

Discontinued • Trial termination • Esophageal Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer

BGB-A3055, an afucosylated anti-CCR8 antibody, preferentially depletes intratumoral regulatory T cells and inhibits tumor growth in preclinical models (AACR 2025) - P1 | "BGB-3055 is a novel fully humanized afucosylated antibody that has high binding affinity to hCCR8, strong CCL1-CCR8 blocking capacity and potent ADCC effect. BGB-A3055 demonstrated strong anti-tumor activity as single agent or in combination with PD-1 antibody. A Ph1 study evaluating BGB-A3055 alone and in combination with Tislelizumab in participants with solid tumor is ongoing (NCT05935098)."

Preclinical • Oncology • Solid Tumor • CCR8

BGB-A3055 Alone and in Combination With Tislelizumab in Participants With Solid Tumors (clinicaltrials.gov) - P1 | N=99 | Terminated | Sponsor: BeiGene | N=263 ➔ 99 | Trial completion date: Mar 2027 ➔ Jan 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Mar 2027 ➔ Jan 2026; This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the CCR8 program.

Enrollment change • IO biomarker • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor • CCR8 • PD-L1

BGB-A3055 Alone and in Combination With Tislelizumab in Participants With Solid Tumors (clinicaltrials.gov) - P1 | N=263 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting

Enrollment closed • IO biomarker • Oncology • Solid Tumor • CCR8 • PD-L1

BGB-A3055 Alone and in Combination With Tislelizumab in Participants With Solid Tumors (clinicaltrials.gov) - P1 | N=263 | Recruiting | Sponsor: BeiGene | Trial completion date: Feb 2025 ➔ Mar 2027 | Trial primary completion date: Feb 2025 ➔ Mar 2027

Trial completion date • Trial primary completion date • Oncology • Solid Tumor • CCR8

Simcere Pharmaceuticals' Phase III study of innovative anti-influenza drug was successful; Junshi Biologics' first-quarter revenue was 380 million yuan [Google translation] (163.com) - "On April 29, according to the CDE official website, Hengrui Medicine’s injection SHR-9839 was approved for clinical use and is planned to be combined with SHR-A2009, or SHR-A1921, or ametinib, or combined with chemotherapy to treat advanced solid tumors...according to the CDE official website, Yangli Pharmaceutical VB15010 tablets were approved for clinical use and plans to conduct research on the treatment of advanced solid tumors....according to the CDE official website, BeiGene’s BGB-A3055 for injection was approved for clinical use and plans to conduct research on the treatment of advanced or metastatic solid tumors."

New trial • Oncology • Solid Tumor

A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=318 | Recruiting | Sponsor: BeiGene

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • CCR8

A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=318 | Recruiting | Sponsor: BeiGene | Phase classification: P1a/1b ➔ P1

Combination therapy • Metastases • Phase classification • Oncology • Solid Tumor • CCR8

A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1a/1b | N=318 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • IO biomarker • Metastases • Oncology • Solid Tumor • CCR8 • PD-L1

A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1a/1b | N=318 | Not yet recruiting | Sponsor: BeiGene

Combination therapy • IO biomarker • Metastases • New P1 trial • Oncology • Solid Tumor • CCR8 • PD-L1