LB1410 / L&L Biopharma - LARVOL DELTA

Phase I study of LB1410, a bivalent TIM-3/PD-1 bispecific antibody, in patients with advanced solid tumors. (ASCO 2026) - P1 | "LB1410 showed an excellent safety profile and promising antitumor efficacy in pts with immune-oncology (IO)-R/R CC. Further studies of LB1410 as monotherapy and in combination with lenvatinib in pts with IO-R/R CC are ongoing."

Bispecific • Clinical • Metastases • P1 data • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Hepatocellular Cancer • Hypertension • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • HAVCR2 • MSI

Phase I/II study of LB1410, a bivalent TIM-3/PD-1 bispecific antibody, in combination with LB4330, a long-acting IL-10, in patients with advanced solid tumors. (ASCO 2026) - P1, P1/2 | "The combination of LB1410 and LB4330 exhibited a manageable safety profile consistent with that observed with each monotherapy. Clinical data in pts with favorable-risk ccRCC support the characteristics and efficacy of LB4330 as an immune-enhancing agent. Efficacy expansion studies are ongoing."

Bispecific • Clinical • Combination therapy • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • Cough • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pruritus • Respiratory Diseases • Solid Tumor • CD8 • CLDN18 • HAVCR2 • IL10

Phase 1 study of LB1410, a bivalent TIM-3/PD-1 bispecific antibody, in patients with advanced solid tumors or lymphoma. (ASCO 2025) - P1 | "LB1410 has a manageable safety profile and demonstrates potential efficacy at tolerable doses in heavily pretreated patients, particularly those with immune-oncology (IO)-refractory or resistant ccRCC and CC."

Clinical • Metastases • P1 data • Anemia • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Heart Failure • Hematological Malignancies • Hypertension • Lymphoma • Oncology • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Solid Tumor • HAVCR2

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

Phase 1 study of LB1410, a bivalent TIM-3/PD-1 bispecific antibody, in patients with advanced solid tumors. (ASCO 2024) - P1 | "LB1410 has manageable safety and shows preliminary efficacy. Additional dose and efficacy expansion study is ongoing in immunotherapy-naive pts with MSS CRC and pts who are resistant to immunotherapy."

Clinical • Metastases • P1 data • Anemia • Hematological Disorders • Oncology • Solid Tumor • HAVCR2

A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001） (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: L & L biopharma Co., Ltd., Shanghai China | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • HAVCR2

A bivalent Tim-3/PD-1 bispecific antibody for the treatment of PD-1 antibody resistant or refractory NSCLC. (ASCO 2022) - "A Phase I, multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of Bis5 in patients with advanced and/or metastatic solid tumors has started. Seven cohorts (0.1, 0.3, 1, 3, 6, 10, 15 mg/kg) are planned to be enrolled sequentially in the dose escalation part. In the expansion part, a cohort group of 10 patients is planned for post PD-1 treated NSCLC as the second or third line treatment."

Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HAVCR2

A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001） (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: L & L biopharma Co., Ltd., Shanghai China

New P1 trial • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • HAVCR2