LBL-033 / Leads Biolabs - LARVOL DELTA

The U.S. FDA Approved the Phase I/II Clinical Trial Application to Evaluate LBL-033, An Anti-MUC16/CD3 Bispecific Antibody Developed by Leads Biolabs, in Advanced Solid Tumors Including Ovarian Cancer (PRNewswire) - "Nanjing Leads Biolabs Co., Ltd...announces that the phase I/II clinical trial application for LBL-033, an anti-MUC16/CD3 bispecific antibody, for the treatment of ovarian cancer and other malignant tumors, has been approved by the FDA (U.S. Food and Drug Administration). At present, no antibody product targeting MUC16 has been approved for marketing both inside and outside China. The study is a multicenter, open-label, dose-escalation and expansion phase Ⅰ/Ⅱ clinical study. The phase Ⅰ part aims to evaluate the safety, tolerability, and pharmacokinetics of LBL-033 for the treatment of subjects with advanced malignancies, and to provide recommended doses for subsequent clinical studies. The primary objective of the Phase Ⅱ part is to evaluate the efficacy of LBL-033."

IND • Trial status • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=468 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

LBL-033, a novel bispecific antibody targeting MUC16 and CD3, for the treatment of tumors over-expressing MUC16 (AACR 2023) - "LBL-033, a novel bispecific antibody targeting CD3 and MUC16 with a unique epitope, which is located at the MUC16 membrane-proximal domain, with affinity differentiation between anti-MUC16 and anti-CD3. It is shown a great anti-tumor efficacy in animal models, with a good safety profile in monkeys. These data support LBL-033 as a novel therapeutic bispecific antibody for ovarian cancer and other MUC16 positive tumors."

IO biomarker • Oncology • Ovarian Cancer • Solid Tumor • MUC16

A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=468 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

Metastases • New P1/2 trial • Oncology • Solid Tumor