BC3195 / Wuxi Biocity - LARVOL DELTA

BC3195, a novel ADC targeting cadherin-3 (CDH3): Preliminary results of a phase I study in patients with advanced solid malignancies (study BC3195-102). (ASCO 2026) - P1 | "The dose of BC3195 was subsequently de-escalated to 1.2 mg/kg and then re-escalated to 2.4 mg/kg along with preventative measures, which included ice chip mouth rinses, dexamethasone mouthwash, and B vitamins in the peri-treatment period, and topical steroids for any skin rash. BC3195 has a manageable safety profile, favorable PK characteristics and demonstrated preliminary antitumor activity in several types of heavily pretreated advanced solid malignancies. Based on shared safety data, enrolment in both BC3195-102 (US) and BC3195-101 (China), which is in dose expansion, is converging on the 2.1 mg/kg DL (NCT06548672)."

ADC • Clinical • Metastases • P1 data • Breast Cancer • Dental Disorders • Fibrosarcoma • Genito-urinary Cancer • Oncology • Prostate Cancer • Sarcoma • Solid Tumor • Stomatitis • CDH3

BC3195, a novel ADC targeting CDH3: Preliminary results of a first-in-human phase I study in patients with advanced solid malignancies. (ASCO 2024) - P1a/1b | "BC3195 exhibited favorable safety profile and PK characteristics up to 1. 2mg/kg. Given BC31095's safety and PK behavior, as well as preliminary activity at the 0."

Clinical • Metastases • P1 data • Anemia • Back Pain • Cough • Hematological Disorders • Musculoskeletal Pain • Oncology • Pain • Pancreatic Cancer • Respiratory Diseases • Solid Tumor • CDH3

BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=111 | Recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ALK • BRAF • EGFR • MET • NTRK

First case report of transformation of adenocarcinoma to adenosquamous carcinoma with giant-cell carcinoma harboring HER2 mutation after zongertinib (BI 1810631) resistance. (PubMed, Lung Cancer) - "This case is the first to elucidate the putative resistance mechanisms to zongertinib in HER2-mutant lung adenocarcinoma might be transformation of adenosquamous with giant-cell carcinoma and acquired HER2 amplification through integrated histological and molecular analyses. These findings highlight the necessity of post-progression biopsy and genomic profiling to characterize resistance evolution and guide subsequent therapy selection."

IO biomarker • Journal • Giant Cell Tumor of Bone • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • AKT2 • CDH3 • HER-2 • MAP3K1 • NF1 • PD-L1 • RB1 • TERT • TP53

BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=111 | Not yet recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd.

IO biomarker • New P1/2 trial • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ALK • BRAF • EGFR • MET • NTRK

BC3195, a novel ADC targeting cadherin-3 (CDH3): Updated results of a first-in-human phase I study in patients with advanced solid malignancies. (ASCO 2025) - P1a/1b | "BC3195 has a manageable safety profile and favorable PK characteristics and demonstrated impressive preliminary antitumor activity in heavily-pretreated pts with NSCLC, of which most had EGFR-mutations (ORR=50%). Dose optimization and expansion are ongoing. Clinical trial information: NCT05957471."

Clinical • Metastases • P1 data • Anemia • Dental Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis • CDH3 • EGFR

BioCity Biopharmaceutics Co., Ltd. Announces Clinical Collaboration to Evaluate BC3195 in Combination with KEYTRUDA (pembrolizumab) in Patients with Locally Advanced or Metastatic Solid Tumors (PRNewswire) - "BioCity Biopharmaceutics Co., Ltd...announced that it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to evaluate the combination of BioCity's BC3195 and MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a global phase 1/2 trial in patients with locally advanced or metastatic solid tumors...Under the terms of the agreement, BioCity will conduct a phase 1/2 clinical trial to evaluate the safety and efficacy of BC3195 in combination with KEYTRUDA. BioCity and MSD each retain all commercial rights to their respective compounds. The recruitment in the clinical study is expected in Q4 2025."

New P1/2 trial • Solid Tumor

Impressive preliminary objective response rates (ORR) of 36% in NSCLC and 80% in EGFRmut NSCLC: Interim Results of a Phase 1 Study of BC3195, a First-in-Class ADC Targeting CDH3, Presented by BioCity at ESMO 2024 (PRNewswire) - P1 | N=27 | NCT05957471 | Sponsor: Biocity Biopharmaceutics Co., Ltd. | "As of the data cut-off date (August 10, 2024), BC3195 demonstrated impressive antitumor activity in patients with advanced non-small cell lung cancer (NSCLC) with an ORR of 36.4% (4 of 11 patients). The ORR was 80% (4 of 5 patients) in NSCLC with epidermal growth factor receptor mutations (EGFRmut). BC3195 demonstrated manageable safety and tolerability, as well as favorable pharmacokinetic characteristics. Dose optimization and further patient accrual in NSCLC, breast cancer, and other types of CDH3-expressing cancers are ongoing....All patients in the dose escalation stage of the study were evaluable for dose-limiting toxicity (DLT). One patient had Grade 3 pharyngitis, considered a DLT, following treatment with BC3195 2.4 mg/kg IV Q3W.Rash, stomatitis and liver function abnormalities were the main adverse events (AEs). Most episodes of rash and stomatitis occurred in the first cycle and were manageable."

P1 data • Lung Cancer • Non Small Cell Lung Cancer

BC3195, a novel ADC targeting CDH3: Preliminary results of a first-in human phase I study in patients with advanced solid malignancies (ESMO 2024) - P1a/1b | "BC3195 exhibited favorable safety profile and PK characteristics up to 2.4mg/kg. Given BC3195's safety and PK behavior, as well as preliminary activity at the 2.4 mg/kg DL, patient enrollment at higher dose levels is ongoing. Clinical trial information: NCT05957471."

Clinical • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CDH3 • EGFR

A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of BC3195 in Patients With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1 | N=148 | Recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd.

Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=27 | Recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd.

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

BioCity announces the first patient dosed with its first-in-class CDH3-targeting ADC BC3195 in a Phase 1 Trial (PRNewswire) - "BioCity Biopharma...announced the dosing of the first patient in a Phase 1a/1b clinical trial of its first-in-class CDH3 antibody drug conjugate (ADC), BC3195 in China. The study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BC3195 in patients with locally advanced or metastatic solid tumors....BioCity Biopharma expects to obtain preliminary clinical data on BC3195 by the end of 2023 from clinical trials in China as well as in the US."

P1 data • Trial status • Oncology • Solid Tumor