HLX60 / Fosun Pharma - LARVOL DELTA

A Study to Investigate the Safety, Tolerability and Efficacy of HLX60 Combination With HLX10 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2025 ➔ Aug 2025 | Trial primary completion date: Feb 2024 ➔ Dec 2024

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • PD-L1

A Phase I Study to Investigate the Safety, Tolerability and PK of HLX60 (Anti-GARP Monoclonal Antibody) in Subjects With Solid Tumors or Lymphoma (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2024 ➔ Aug 2024

Enrollment closed • Metastases • Trial primary completion date • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Lymphoma • Oncology • Solid Tumor

A Phase I Study to Investigate the Safety, Tolerability and PK of HLX60 (Anti-GARP Monoclonal Antibody) in Subjects With Solid Tumors or Lymphoma (clinicaltrials.gov) - P1 | N=11 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Lymphoma • Oncology • Solid Tumor

A Study to Investigate the Safety, Tolerability and Efficacy of HLX60 Combination With HLX10 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting | N=11 ➔ 20 | Trial completion date: May 2024 ➔ Feb 2025 | Trial primary completion date: Sep 2023 ➔ Feb 2024

Enrollment change • Enrollment open • IO biomarker • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • FOXP3 • PD-L1

First Patient Dosed in the Phase 1 Clinical Trial of Henlius’ Novel Anti-TIGIT Fc Fusion Protein HLX53 (Henlius Press Release) - "Shanghai Henlius Biotech, Inc. (2696.HK) announced the first subject was dosed in Australia in a phase 1 clinical trial (HLX60HLX10-FIH101) of its independently developed HLX60 (recombinant anti-GARP humanised monoclonal antibody injection) in combination with HANSIZHUANG, an innovative anti-PD-1 mAb independently developed by the company for the treatment of advanced or metastatic solid tumours...This phase 1 study aims to evaluate the safety, tolerability, and preliminary efficacy of HLX60 plus serplulimab in patients with advanced or metastatic solid tumours."

Trial status • Oncology • Solid Tumor

A Phase I Study to Investigate the Safety, Tolerability and PK of HLX60 (Anti-GARP Monoclonal Antibody) in Subjects With Solid Tumors or Lymphoma (clinicaltrials.gov) - P1 | N=11 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Lymphoma • Oncology • Solid Tumor

The IND Application of Henlius’ Novel Anti-GARP mAb HLX60 Approved by NMPA (Henlius Press Release) - "Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for clinical trial of HLX60 (recombinant anti-GARP humanised monoclonal antibody injection), independently developed by the company, was approved by the National Medical Products Administration (NMPA) for the treatment of solid tumours and lymphomas. HLX60 is the first IND approved anti-GARP monoclonal antibody (mAb) in China and is expected to be the first-in-class anti-GARP mAb."

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

A Study to Investigate the Safety, Tolerability and Efficacy of HLX60 Combination With HLX10 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=11 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

IO biomarker • New P1 trial • Oncology • Solid Tumor • FOXP3 • PD-L1