BGB-C354 / BeOne Medicines - LARVOL DELTA

BGB-C354-101: A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=63 | Completed | Sponsor: BeOne Medicines | Active, not recruiting ➔ Completed | N=120 ➔ 63 | Trial completion date: Jan 2027 ➔ May 2026 | Trial primary completion date: Dec 2026 ➔ May 2026

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

BGB-C354, a novel B7H3 ADC with high DAR stability and strong bystander effect, demonstrates robust antitumor activity in preclinical models (AACR 2025) - P1 | "Consistent with its mechanism of action, DNA damage and apoptosis biomarker changes were induced by BGB-C354 in a dose-dependent manner after single dosing in preclinical models. Recently, a phase I study of BGB-C354 has been initiated to investigate its potential safety and preliminary efficacy in patients with B7H3-expressing advanced solid tumors (NCT06422520)."

ADC • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Oncology • Solid Tumor • CD276

BGB-C354-101: A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting

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

BGB-C354-101: A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: BeiGene | N=62 ➔ 120

Enrollment change • Oncology • Solid Tumor

BeiGene’s ADC cancer drug combination therapy approved for clinical trials in China [Google translation] (Sina Corp) - "According to the ClinicalTrials website, BeiGene is conducting a Phase 1 clinical study in the United States, Australia, and China to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of BGB-C354 alone or in combination with the anti-PD-1 antibody tislelizumab in patients with advanced solid tumors."

New P1 trial • Oncology • Solid Tumor

BeiGene Announces Fourth Quarter and Full Year 2024 Financial Results and Business Update (Businesswire) - "Anticipate...internal proof-of-concept data for BG-60366 (EGFR CDAC), BGB-53038 (panKRAS inhibitor), BG-C137 (FGFR2b ADC), BGB-C354 (B7H3 ADC), and BG-C477 (CEA ADC) in the second half of 2025."

P1 data • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors (ChiCTR) - P1 | N=92 | Not yet recruiting | Sponsor: Jilin Cancer Hospital; Jilin Cancer Hospital

Combination therapy • Metastases • New P1 trial • Breast Cancer • Castration-Resistant Prostate Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Sarcoma • Small Cell Lung Cancer • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • BRAF • CD276 • EGFR • HER-2 • NTRK • ROS1

BeiGene’s new ADC cancer drug approved for clinical trials in China, targeting B7-H3! [Google translation} (bydrug.pharmcube.com) - "Today (September 20), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration just announced that BeiGene's Class 1 new drug BGB-C354 for injection has been approved for clinical trials and is intended to be developed to treat patients with advanced solid tumors. Public information shows that BGB-C354 is an antibody-drug conjugate (ADC) targeting B7-H3...This is the first time that the product has been approved for clinical trials in China. BGB-C354 is an ADC targeting B7-H3 and is intended to be developed to treat lung cancer and head and neck squamous cell carcinoma (HNSCC)."

New trial • Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

BGB-C354-101: A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=62 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

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

BGB-C354-101: Phase 1 First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=62 | Not yet recruiting | Sponsor: BeiGene

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