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 - 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 Haematological 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 - 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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Protocol Number - AB928CSP0002

A Phase 1/1b Study To Evaluate The Safety And Tolerability Of Immunotherapy Combinations In Participants With Breast Or Gynecologic Malignancies

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Protocol Number - AB928CSP0005

A Phase 1 Study To Evaluate The Safety And Tolerability Of Immunotherapy Combinations In Participants With Advanced Malignancies

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Protocol Number - BO40933

A Phase 1b, Open-Label, Multicenter Study Evaluating The Safety And Efficacy Of Ipatasertib In Combination With Rucaparib In Patients With Advanced Breast, Ovarian, Or Prostate Cancer

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Protocol Number - GO39932

A Phase Ia/Ib, Multicenter, Open-Label, Dose Escalation, Dose Expansion Study Evaluating The Safety, Pharmacokinetics, And Activity Of GDC-9545 Alone Or In Combination With Palbociclib And/Or LHRH Agonist In Patients With Locally Advanced Or Metastatic Estrogen Receptor Positive Breast Cancer

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Protocol Number - XNW7201-1-02

A Phase I, Open-Label, Multi-Center, Non-Randomized, Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetic Profile Of XNW7201 In Subjects With Advanced Solid Tumors

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Protocol Number - C-700-01

A Phase 1 / 2, Open-Label, Multiple Ascending Dose Trial To Investigate The Safety, Tolerability, Pharmacokinetics, Biological, And Clinical Activity Of AGEN2034 In Subjects With Metastatic Or Locally Advanced Solid Tumors, With Expansion To Second Line Cervical Cancer

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Melanoma

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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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 Haematological 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 Naive 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 - 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 - BO40933

A Phase 1b, Open-Label, Multicenter Study Evaluating The Safety And Efficacy Of Ipatasertib In Combination With Rucaparib In Patients With Advanced Breast, Ovarian, Or Prostate Cancer

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Protocol Number - 64091742PCR3001

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study Of Niraparib In Combination With Abiraterone Acetate And Prednisone Versus Abiraterone Acetate And Prednisone For Treatment Of Subjects With Metastatic Prostate Cancer

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Protocol Number - C-700-01

A Phase 1 / 2, Open-Label, Multiple Ascending Dose Trial To Investigate The Safety, Tolerability, Pharmacokinetics, Biological, And Clinical Activity Of AGEN2034 In Subjects With Metastatic Or Locally Advanced Solid Tumors, With Expansion To Second Line Cervical Cancer

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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 - 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 - AB928CSP0002

A Phase 1/1b Study To Evaluate The Safety And Tolerability Of Immunotherapy Combinations In Participants With Breast Or Gynecologic Malignancies

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Protocol Number - BO40933

A Phase 1b, Open-Label, Multicenter Study Evaluating The Safety And Efficacy Of Ipatasertib In Combination With Rucaparib In Patients With Advanced Breast, Ovarian, Or Prostate Cancer

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Protocol Number - GO39932

A Phase Ia/Ib, Multicenter, Open-Label, Dose Escalation, Dose Expansion Study Evaluating The Safety, Pharmacokinetics, And Activity Of GDC-9545 Alone Or In Combination With Palbociclib And/Or LHRH Agonist In Patients With Locally Advanced Or Metastatic Estrogen Receptor Positive Breast Cancer

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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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Protocol Number - AB928CSP0002

A Phase 1/1b Study To Evaluate The Safety And Tolerability Of Immunotherapy Combinations In Participants With Breast Or Gynecologic Malignancies

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Protocol Number - BO40933

A Phase 1b, Open-Label, Multicenter Study Evaluating The Safety And Efficacy Of Ipatasertib In Combination With Rucaparib In Patients With Advanced Breast, Ovarian, Or Prostate Cancer

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Protocol Number - C-700-01

A Phase 1 / 2, Open-Label, Multiple Ascending Dose Trial To Investigate The Safety, Tolerability, Pharmacokinetics, Biological, And Clinical Activity Of AGEN2034 In Subjects With Metastatic Or Locally Advanced Solid Tumors, With Expansion To Second Line Cervical Cancer

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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 - 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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