Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

HLX301 : A Phase 1/2 Study of HLX301, A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in Patients With Locally Advanced or Metastatic Solid Tumors

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer

Systemic therapy | Blood / Myeloma / Lymphoma,Bowel (colorectum),Brain and spinal cord,Breast,CUP,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAcute Lymphoblastic Lymphoma,Adrenocortical carcinoma,Anus,Astrocytoma,Basal cell carcinoma,B-Cell Non Hodgkin Lymphoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cancer of Unknown Primary,Central Nervous System,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Diffuse Large Cell Lymphoma,Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Follicular Lymphoma,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastrointestinal stromal tumors (GISTs),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Germ cell tumour,Glioblastoma (GBM) ,Glioma,Head and neck,Hodgkin's Disease (Hodgkin's Lymphoma),Kidney,Langerhans Cell Histiocytosis,Leiomyosarcoma,Liposarcoma,Liver,Lung,Lymphoma,Mantle Cell Lymphoma,Medullablastoma,Melanoma (Ocular),Melanoma (Skin),Meningioma,Merkel cell,Mesothelioma,Mouth (including tonsil, tongue, soft palate, cheeks, lips, gum),Neuroblastoma,Neuroendocrine tumours,Non-Small Cell Lung Cancer,Nose (nasopharynx),Oesophagus,Oral cavity,Oropharynx,Osteosarcoma,Ovary,Pancreas,Paroxysmal Nocturnal Hemoglobinuria (PNH),Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Skin Lymphoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Squamous cell carcinoma ,Stomach,Synovial Sarcoma,T-Cell Lymphoma,Testis,Throat (hypopharynx),Thyroid,Urinary tract,Urothelial,Uterus,Vagina,Voice box (larynx),Vulva,Wilm's tumour

Trial Overview Read MoreRead more

This phase I/II study is seeking to determine the appropriate dose level, safety and effectiveness of a new cancer treatment (HLX301) in people with locally advanced or metastatic solid cancers.

This trial is treating patients with advanced or metastatic solid cancers, non-small cell lung cancer, gastric/oesophageal junction cancer, head and neck squamous cell carcinoma and urothelial carcinoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1/2 Study of HLX301, A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in Patients With Locally Advanced or Metastatic Solid Tumors

Commercial Sponsor

Shanghai Henlius Biotech


This study has three parts: phase 1a dose escalation, phase 1b dose expansion, and phase 2 clinical expansion. Phase 1 a is seeking to investigate the safety and determine the maximum tolerated dose (MTD) of HLX301. Six dose levels of 0.25mg/kg, 1mg/kg, 2.5mg/kg, 5mg/kg, 10mg/kg, and 15mg/kg are planned for dose finding. HLX301 will be administered as a single intravenous (IV) infusion on Day 1 in each 14-day cycle. Phase 1b will enrol participants with non-small cell lung cancer in two expansion cohorts at doses equal to or lower than the MTD to better understand the safety, tolerability and effectiveness of HLX301. HLX301 will be administered via IV infusion on Day 1 in each 14-day cycle. Phase 2 will further evaluate the effect of HLX301 in four cohorts of participants: non-small cell lung cancer with PD-L1 expression, gastric/oesophageal junction cancer with PD-L1 expression, head and neck squamous cell carcinoma with PD-L1 expression, and urothelial carcinoma with PD-L1 expression.

Recruiting Hospitals Read MoreRead more

Cabrini Education and Research Precinct
Micheleine Uhe
(03) 9508 3481

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.