LB4330 / L&L Biopharma - LARVOL DELTA

Efficacy and Safety of LB1410 Plus Lenvatinib With or Without LB4330 in Advanced Recurrent/Metastatic Cervical Cancer (clinicaltrials.gov) - P2/3 | N=120 | Not yet recruiting | Sponsor: L & L Bio Co., Ltd., Ningbo, China

New P2/3 trial • Cervical Cancer • Oncology • Solid Tumor

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LB4330 in Patients With Advanced Solid Tumors（MEETCD8-001） (clinicaltrials.gov) - P1 | N=40 | Terminated | Sponsor: L & L Bio Co., Ltd., Ningbo, China | N=66 ➔ 40 | Trial completion date: Sep 2026 ➔ Dec 2024 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2025 ➔ Dec 2024; Due to adjustments in the sponsor's development strategy, it has been decided to terminate the study.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cholangiocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Pancreatic Ductal Adenocarcinoma • Solid Tumor

TRIGGERCD8: A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=194 | Recruiting | Sponsor: L & L biopharma Co., Ltd., Shanghai China | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

TRIGGERCD8: A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=194 | Not yet recruiting | Sponsor: L & L biopharma Co., Ltd., Shanghai China

Combination therapy • Metastases • New P1/2 trial • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A phase 1 study of LB4330, a peptide fused to CLDN18.2 antibody targeting the tumor antigen associated (TAA) CD8+T cells in patients with advanced solid tumors. (ASCO 2024) - P1 | "LB4330 has manageable safety and shows preliminary efficacy at tolerable doses. Dose and efficacy expansion study is ongoing in more PDACs and other solid tumors. In the meantime, Phase I study of LB4330 in combination with PD1/TIM-3 bispecific antibody LB1410 has been initiated in different tumor types as well."

Clinical • Metastases • P1 data • Anemia • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Pruritus • Solid Tumor • Thrombocytopenia • CD8 • CLDN18 • HAVCR2 • IL10 • IL18

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LB4330 in Patients With Advanced Solid Tumors（MEETCD8-001） (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: L & L biopharma Co., Ltd., Shanghai China | Trial primary completion date: Sep 2026 ➔ Sep 2025

Metastases • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of LB4330, a peptide fused to CLDN18.2 antibody targeting the tumor antigen associated CD8+t CELLS in patients with advanced solid tumors. (ASCO 2023) - P1 | "Enrollment in cohort 1 began in Nov 2022. Clinical trial information: NCT05707676."

Clinical • IO biomarker • Metastases • P1 data • PK/PD data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Gastrointestinal Disorder • Infectious Disease • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD8 • CLDN18

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LB4330 in Patients With Advanced Solid Tumors（MEETCD8-001） (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: L & L biopharma Co., Ltd., Shanghai China

Metastases • New P1 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18