LBL-015 / Leads Biolabs - LARVOL DELTA

Phase I/II Clinical Trial of LBL-015 for Injection (clinicaltrials.gov) - P1/2 | N=25 | Completed | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Recruiting ➔ Completed | N=202 ➔ 25 | Trial completion date: Dec 2024 ➔ Dec 2023 | Trial primary completion date: Oct 2024 ➔ Dec 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Anti-PD-1/TGF-βRII bispecific antibody fusion protein LBL-015 in patients with advanced malignant tumors: A phase I, first-in-human, open-label, multicenter, dose-escalation study. (ASCO 2024) - P1/2 | "LBL-015 has demonstrated good safety profiles in patients with advanced solid tumors. The encouraging preliminary efficacy signals indicated additional studies with a focus on TGFβ signaling pathway deregulated or activated tumors such as RCC, pancreatic cancer, etc. should be further explored."

Clinical • Metastases • P1 data • Anemia • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Infectious Disease • Kidney Cancer • Nasopharyngeal Carcinoma • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Renal Disease • Respiratory Diseases • Solid Tumor • TGFB1

Leads Biolabs is Proud to Announce its Participation in the 2024 ASCO Annual Meeting with One Oral Presentation and Two Posters. (PRNewswire) - "These presentations will include one oral presentation, two posters, and one online publication, showcasing advancements in various cancer indications such as nasopharyngeal cancer (NPC), extrapulmonary neuroendocrine carcinoma (EP-NEC), hepatocellular carcinoma (HCC), and renal cell carcinoma (RCC)....According to the results in the oral presentation, LBL-024 demonstrated good safety profile and very promising antitumor effects in patients with advanced malignant tumors....This phase Ⅰb/Ⅱ study indicates that the combination of LBL-007 and tislelizumab is well-tolerated in patients with advanced malignant tumors....In a Phase 1 clinical study, LBL-015 has demonstrated a good safety profile and encouraging preliminary efficacy signals in patients with advanced solid tumors....The data from the Phase 1 study indicate that LBL-019 is well tolerable and has demonstrated preliminary efficacy in patients with advanced malignant tumors."

P1 data • P1/2 data • Hepatocellular Cancer • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Renal Cell Carcinoma • Solid Tumor

Phase I/II Clinical Trial of LBL-015 for Injection (clinicaltrials.gov) - P1/2 | N=202 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Trial primary completion date: Oct 2023 ➔ Oct 2024

Metastases • Trial primary completion date • Oncology • Solid Tumor

Phase I/II Clinical Trial of LBL-015 for Injection (clinicaltrials.gov) - P1/2; N=202; Recruiting; Sponsor: Nanjing Leads Biolabs Co.,Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor

Phase I/II Clinical Trial of LBL-015 for Injection (clinicaltrials.gov) - P1/2; N=202; Not yet recruiting; Sponsor: Nanjing Leads Biolabs Co.,Ltd

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

[VIRTUAL] LBL-015, a novel anti-PD-1 fused with TGF-βRII, shows a great anti-tumor activity in a mouse MC38 model (AACR 2021) - "In vitro LBL-015 could block PD-1-PD-L1 interaction, recovering NFAT reporter gene signal, with EC50 of 0.1565 nM, which was much more potent than M7824 (EC50 of 0.5412 nM). LBL-015, an anti-PD-1 and TGF-β bispecific fusion protein was shown a great synergetic anti-tumor efficacy in vitro to antagonize both tumor immune evasion and aberrant microenvironment induced by PD-1 and TGF-β1, also in a mouse tumor model, LBL-015 strongly inhibited tumor growth in a dose dependent manner, hence a promising bispecific fusion protein for further clinical development."

IO biomarker • Preclinical • Oncology • IFNG • TGFB1