The Oncology Clinical Trials Program enables patients to access a wide spectrum of newly advanced treatments including immunotherapeutic drugs and targeted therapies for a range of solid and haematological malignancies.

 

Established in 2003 and led by Associate Professor Gary Richardson OAM, the Department aims to provide compassionate, state-of-the-art care for cancer patients and continued advancements in the prevention, diagnosis, treatment and cure of cancer via a combination of research, education and clinical practice.

Phase I

Protocol Number - CK-301-101

A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects with Advanced Cancers

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Protocol Number - ALE17001/FN-1501-UP1

A phase 1, multi-center, open-label, single-arm, dose-escalation, clinical study to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of FN-1501 monotherapy in patients with advanced solid tumors

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Protocol Number - HMPL-523 (2015-523-00AU1)

A Phase I, open-label, dose-escalation study of the safety and pharmacokinetics of HMPL-523 in patients with relapsed or refractory hematological malignancies (expansion phase)

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Protocol Number - KN046-AUS-001

An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of KN046 in Subjects with Advanced Solid Tumors.

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Protocol Number - HLX20-001

A Phase 1 Study of HLX20, a Human Monoclonal Antibody Targeting PD-L1Protein in Patients With Advanced Solid Tumors (HLX20)

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Protocol Number - B9991023

Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies

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Protocol Number - FPT155-001

PHASE 1A/1B STUDY OF FPT155 IN PATIENTS WITH ADVANCED SOLID TUMOURS

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Protocol Number - CV202-103

A Phase 1b/2 study of BMS 813160 in combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors.

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Protocol Number - AB928CSP0003

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Gastrointestinal Malignancies

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Melanoma

Protocol Number - CK-301-101

A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects with Advanced Cancers

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Protocol Number - KN046-AUS-001

An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of KN046 in Subjects with Advanced Solid Tumors.

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Protocol Number - HLX20-001

A Phase 1 Study of HLX20, a Human Monoclonal Antibody Targeting PD-L1Protein in Patients With Advanced Solid Tumors (HLX20)

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Lung

Protocol Number - KN046-AUS-001

An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of KN046 in Subjects with Advanced Solid Tumors.

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Protocol Number - HLX20-001

A Phase 1 Study of HLX20, a Human Monoclonal Antibody Targeting PD-L1Protein in Patients With Advanced Solid Tumors (HLX20)

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Protocol Number - B9991023

Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies

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Haematological / Blood cancers

Protocol Number - HMPL-523 (2015-523-00AU1)

A Phase I, open-label, dose-escalation study of the safety and pharmacokinetics of HMPL-523 in patients with relapsed or refractory hematological malignancies (expansion phase)

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Protocol Number - ACE-536-MDS-002

A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF LUSPATERCEPT (ACE-536) VERSUS EPOETIN ALFA FOR THE TREATMENT OF ANEMIA DUE TO IPSS-R VERY LOW, LOW OR INTERMEDIATE RISK MYELODYSPLASTIC SYNDROMES (MDS) IN ESA NAÏVE SUBJECTS WHO REQUIRE RED BLOOD CELL TRANSFUSIONS

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Colorectal

Protocol Number - WEHI-ctDNA-04

Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage II Colon Cancer (DYNAMIC)

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Protocol Number - KN046-AUS-001

An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of KN046 in Subjects with Advanced Solid Tumors.

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Protocol Number - WEHI-ctDNA11

Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Locally Advanced Rectal Cancer: A Multicentre Randomised Study

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Protocol Number - HLX20-001

A Phase 1 Study of HLX20, a Human Monoclonal Antibody Targeting PD-L1Protein in Patients With Advanced Solid Tumors (HLX20)

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Genitourinary

Protocol Number - CO-338-052

TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

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Protocol Number - CA209914

A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

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Protocol Number - CX-839-008

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination with Cabozantinib (CB-Cabo) vs.Placebo with Cabozantinib (Pbo-Cabo) in Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)

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Protocol Number - KN046-AUS-001

An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of KN046 in Subjects with Advanced Solid Tumors.

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Protocol Number - HLX20-001

A Phase 1 Study of HLX20, a Human Monoclonal Antibody Targeting PD-L1Protein in Patients With Advanced Solid Tumors (HLX20)

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Protocol Number - B9991023

Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies

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Breast Cancer

Protocol Number - C040016

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer.

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Protocol Number - D081CC00006

A randomized, double-blind, parallel group, placebo-controlled multicentre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

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Protocol Number - KN046-AUS-001

An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of KN046 in Subjects with Advanced Solid Tumors.

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Protocol Number - HLX20-001

A Phase 1 Study of HLX20, a Human Monoclonal Antibody Targeting PD-L1Protein in Patients With Advanced Solid Tumors (HLX20)

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Gynaecological

Protocol Number - WEHI-ctDNA-10

Circulating Tumour DNA as a Marker of Residual Disease and Response to Adjuvant Chemotherapy in Stage I-III Optimally Debulked Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (EOC)

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Protocol Number - KN046-AUS-001

An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of KN046 in Subjects with Advanced Solid Tumors.

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Protocol Number - HLX20-001

A Phase 1 Study of HLX20, a Human Monoclonal Antibody Targeting PD-L1Protein in Patients With Advanced Solid Tumors (HLX20)

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Gastrointestinal

Protocol Number - KN046-AUS-001

An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of KN046 in Subjects with Advanced Solid Tumors.

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Protocol Number - HLX20-001

A Phase 1 Study of HLX20, a Human Monoclonal Antibody Targeting PD-L1Protein in Patients With Advanced Solid Tumors (HLX20)

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Protocol Number - CA224-060

A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (anti-LAG-3) plus Nivolumab in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy as First-Line Treatment in Patients with Gastric or Gastroesophageal Junction Adenocarcinoma

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Protocol Number - AB928CSP0003

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Gastrointestinal Malignancies

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Pancreatic

Protocol Number - AM0010-301

A Randomized Phase 3 Study of AM0010 in Combination with FOLFOX Compared with FOLFOX Alone as Second-line Therapy in Patients with Metastatic Pancreatic Cancer that has Progressed During or Following a First-Line Gemcitabine Containing Regimen

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Protocol Number - KN046-AUS-001

An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of KN046 in Subjects with Advanced Solid Tumors.

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Protocol Number - HLX20-001

A Phase 1 Study of HLX20, a Human Monoclonal Antibody Targeting PD-L1Protein in Patients With Advanced Solid Tumors (HLX20)

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Protocol Number - ct-DNA-09

Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Early Stage Pancreatic Cancer: A Multicentre Randomised Study (DYNAMIC-Pancreas)

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