HLX-53 / Fosun Pharma - LARVOL DELTA

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. (clinicaltrials.gov) - P2 | N=117 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

The first patient was dosed in the Phase II clinical trial of HLX53 combined with H drug and Hanbetai as the first-line treatment for hepatocellular carcinoma in a dual immune combined anti-vascular targeted therapy [Google translation] (Sina Corp) - "On August 8, 2024...announced that the first patient was dosed in a Phase II clinical trial (NCT06349980) of the company's independently developed innovative anti-TIGIT Fc fusion protein HLX53 in combination with H-drugs HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) in patients with locally advanced or metastatic hepatocellular carcinoma."

Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

IND Application for the Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein HLX53 in Combination with HANSIZHUANG Plus HANBEITAI for the First-Line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients Approved by NMPA (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the investigational new drug application (IND) for the clinical trial of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first line treatment of locally advanced or metastatic hepatocellular carcinoma, has been approved by the National Medical Products Administration (NMPA). A phase 2 clinical trial will be initiated to evaluate the safety, tolerance and efficacy of the multiple immunotherapy-based treatment combinations in patients with advanced or metastatic hepatocellular carcinoma."

New P2 trial • Hepatocellular Cancer

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 With or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. (clinicaltrials.gov) - P2 | N=117 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Metastases • New P2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

A Phase I Clinical Study of HLX53 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | N=20 ➔ 12 | Trial primary completion date: Aug 2024 ➔ Dec 2024

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

A Phase I Clinical Study of HLX53 in Advanced/Metastatic Solid Tumors or Lymphoma (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • TIGIT

Henlius (02696): Phase 1 clinical study of HLX53 for the treatment of advanced/metastatic solid tumors or lymphoma completed the first patient administration in China [Google translation] (Zhitong Finance) - "Zhitong Finance APP news, Fuhong Henlius...announced that recently, the company's self-developed anti-TIGIT Fc fusion protein HLX53 (HLX53) for the treatment of advanced / metastatic solid tumors or lymphoma phase 1 clinical research in the first patient was administered in China (excluding Hong Kong, Macao and Taiwan, the same below)....This study is an open-label, dose-escalation, first-in-human Phase 1 clinical study designed to evaluate the safety and tolerability of HLX53 in patients with advanced or metastatic solid tumors or lymphomas who have no or failed standard therapy , pharmacokinetics and preliminary efficacy."

Trial status • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

A Phase I Clinical Study of HLX53 in Advanced/Metastatic Solid Tumors or Lymphoma (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • TIGIT

[VIRTUAL] A novel single domain antibody targeting TIGIT for cancer use in combination therapies (AACR 2021) - "In mixed lymphocyte reaction assay (MLR), HLX53 significantly increased IL2 secretion compared to Tiragolumab and Vibostolimab analogues. In addition to its unique epitope/MOA, HLX53 being a sdAb has a shorter half-life and thus potentially a better tumor penetration and a differentiated PK/PD profile. Understanding pharmacokinetic and pharmacodynamic relationships enables a dosing regimen providing adequate target coverage and superior tumor eradication."

Combination therapy • Oncology • CTLA4 • IL2 • NECTIN2 • TIGIT