HLX301 / Fosun Pharma - LARVOL DELTA

Safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of HLX301, a bispecific antibody targeting PD-L1 and TIGIT, in patients with advanced solid tumors. (ASCO 2025) - P1/2 | "HLX301 showed an acceptable safety profile with preliminary anti-tumor activity. These findings could support further clinical investigation."

Clinical • Metastases • PK/PD data • Musculoskeletal Pain • Oncology • Solid Tumor • CD8 • TIGIT

HLX301 (TIGIT×PDL1 Bispecific) in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Shanghai Henlius Biotech | Trial primary completion date: Mar 2023 ➔ Sep 2023

IO biomarker • Metastases • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study Evaluating the Safety, Tolerability, Pharmacokinetic and Efficacy of HLX301(TIGIT×PDL1 Bispecific) in Locally Advanced/Metastatic Solid Tumors or Lymphoma (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Shanghai Henlius Biotech | Trial primary completion date: Jun 2023 ➔ Sep 2023

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

A Study Evaluating the Safety, Tolerability, Pharmacokinetic and Efficacy of HLX301(TIGIT×PDL1 Bispecific) in Locally Advanced/Metastatic Solid Tumors or Lymphoma (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

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

First Subject Dosed in China on Phase 1/2 Trial of Henlius' Anti-PD-L1×TIGIT Bispecific Antibody (Henlius Press Release) - "Shanghai Henlius Biotech, Inc...announced that the first subject has been dosed in a phase 1/2 clinical trial of HLX301, a recombinant anti-PD-L1 and anti-TIGIT bispecific antibody (BsAb), for the treatment of locally advanced or metastatic solid tumours or lymphomas in China....HLX301 is expected to be a first-in-class anti-PD-L1×TIGIT BsAb."

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

A Study Evaluating the Safety, Tolerability, Pharmacokinetic and Efficacy of HLX301(TIGIT×PDL1 Bispecific) in Locally Advanced/Metastatic Solid Tumors or Lymphoma (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1/2 trial • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Lymphoma • Oncology • Solid Tumor

HLX301 (TIGIT×PDL1 Bispecific) in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Shanghai Henlius Biotech | Initiation date: Jan 2022 ➔ May 2022

Trial initiation date • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

HLX301 (TIGIT×PDL1 Bispecific) in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=150; Recruiting; Sponsor: Shanghai Henlius Biotech; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • IO biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Henlius Novel Anti PD-L1/TIGIT Bispecific Antibody Received Clinical Trial Approval in Australia (PRNewswire-Asia) - "Shanghai Henlius Biotech...announced that the filing of a clinical trial for HLX301, a Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in Patients with locally advanced or metastatic solid tumours has been approved by the Bellberry Human Research Ethics Committee ('HREC'), and Clinical Trial Notification ('CTN') has been acknowledged by the Therapeutic Goods Administration ('TGA'), Australia. The Phase 1 clinical study in Australia is intended to be initiated soon."

New P1 trial • Oncology • Solid Tumor

HLX301 (TIGIT×PDL1 Bispecific) in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=150; Not yet recruiting; Sponsor: Shanghai Henlius Biotech

Clinical • IO biomarker • New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck