Early Drug Development / Phase One Clinical Trials

The Early Drug Development (EDD) team offers clinical trials that test new treatments sometimes for the first time in humans. The purpose of these clinical trials are to find a safe dose of the treatment and to determine if it is working against cancer. These trials may be open to one or multiple different cancer types.

If you would like to be considered for a clinical trial you will require a referral from your current treating team. Visit the Joining a Clinical Trial page for referral information. 

For more information on clinical trials, get in contact with our cancer clinical trials enquiry coordinator.

Clinical Trials Enquiry Coordinator

Business hours, Mon to Friday between 9am - 2pm
Email Clinical Trials Enquiries
Phone (03) 8559 7456

Open and Recruiting Clinical Trials

Title

A Phase 1a/1b, first-in-human, open-label, non-randomized, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AXA-042 as monotherapy and in combination with checkpoint 

Trial ID

ACTRN12622000993796

Cancer type

All solid cancers (cancer in the ‘solid’ organs such as breast or lung) except for brain and blood cancers

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B167, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors

Trial ID

NCT05494762

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

First-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors

Trial ID

NCT04901806

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung), including brain cancer and desmoplastic small round cell tumor (DSRCT) 

Status

Open and recruiting

Phase

Phase one / two: A phase one / two clinical trial combines a phase one and two. The phase one tests new treatments sometimes for the first time in humans, usually in a small group of patients. The phase two part tests the new treatment in a larger group of patients with selected cancer types. The aim of a phase one / two is to find the best dose of the new treatment and see if it works against the cancer

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry

Title

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced or Metastatic Solid Tumors

Trial ID

NCT05381909

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

Trial ID

NCT05417594

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one / two: A phase one / two clinical trial combines a phase one and two. The phase one tests new treatments sometimes for the first time in humans, usually in a small group of patients. The phase two part tests the new treatment in a larger group of patients with selected cancer types. The aim of a phase one / two is to find the best dose of the new treatment and see if it works against the cancer

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A First-in-Human Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

Trial ID

NCT04986865

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung) and mature B-cell non-Hodgkin lymphoma 

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of AMX 818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Trial ID

NCT05356741

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

An Open Label, Signal Seeking, Translational, Phase II Trial of Pamiparib in Combination With Tislelizumab in Patients With Advanced Tumours With Homologous Recombination Repair Defects

Trial ID

NCT04985721

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants With Advanced or Metastatic Solid Malignancies

Trial ID

NCT05123482

Cancer type

Breast, ovarian, endometrial and cholangiocarcinoma cancers

Status

Open and recruiting

Phase

Phase one / two: A phase one / two clinical trial combines a phase one and two. The phase one tests new treatments sometimes for the first time in humans, usually in a small group of patients. The phase two part tests the new treatment in a larger group of patients with selected cancer types. The aim of a phase one / two is to find the best dose of the new treatment and see if it works against the cancer

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Trial ID

NCT04649385

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Trial ID

NCT04699188

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one / two: A phase one / two clinical trial combines a phase one and two. The phase one tests new treatments sometimes for the first time in humans, usually in a small group of patients. The phase two part tests the new treatment in a larger group of patients with selected cancer types. The aim of a phase one / two is to find the best dose of the new treatment and see if it works against the cancer

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

Phase 1, Multi-Center, Open-Label, Study to Evaluate the Safety, Tolerability, and PK of VT3989 in Patients With Refractory Locally Advanced or Metastatic Solid Tumors Enriched for Tumors Harboring Mutations of the NF2 Gene

Trial ID

NCT04665206

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Trial ID

NCT04589845

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung) with specific changes in the genes of the cancer

Status

Open and recruiting

Phase

Phase Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

Trial ID

NCT04644068

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one / two: A phase one / two clinical trial combines a phase one and two. The phase one tests new treatments sometimes for the first time in humans, usually in a small group of patients. The phase two part tests the new treatment in a larger group of patients with selected cancer types. The aim of a phase one / two is to find the best dose of the new treatment and see if it works against the cancer

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Trial ID

NCT04449874

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung), including lung and colorectal

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-017 Monotherapy in Patients With Advanced Solid Tumors and Hematological Malignancies

Trial ID

NCT04305249

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung) and some blood cancers

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of the Anti OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Trial ID

NCT04215978

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Phase Ia/Ib, Open-Label, Multicenter, Global, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XmAb24306 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Trial ID

NCT04250155

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

The Cancer Molecular Screening and Therapeutics (MoST) Program - A framework protocol for multiple, parallel, signal-seeking clinical studies of novel molecularly targeted therapies for patients with advanced cancer and unmet clinical need

Trial ID

ACTRN12616000908437

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A First-in-Human, Phase 1a/1b, Open Label, Dose-Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of the RAF Dimer Inhibitor BGB-3245 in Patients With Advanced or Refractory Tumors

Trial ID

NCT04249843

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of a RAF Dimer Inhibitor BGB-283 in Combination With MEK Inhibitor PD-0325901 in Patients With Advanced or Refractory Solid Tumors

Trial ID

NCT03905148

Cancer type

Solid cancers (cancer in the ‘solid’ organs such as breast or lung)

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A phase I, multicenter, open-label, first-in human, dose escalation and expansion study of AZD9592 as monotherapy and in combination with anti-cancer agents in patients with advanced solid tumors

Trial ID

NCT05647122

Cancer type

Solid cancers 

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Pilot Study of Lewis Y (LeY) targeting Chimeric Antigen Receptor(CAR) T cells in combination with Nivolumab in Patients With LeY Expressing Solid Tumours

Trial ID

ACTRN12622001542785

Cancer type

Solid cancers expressing Lewis-Y

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Phase 1a/1b, First-in-human, Open-label, Non-randomized, Multicenter, Dose-escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Efficacy, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of IOS-1002 Administered Alone and in Combination With a PD-1 Monoclonal Antibody in Advanced Solid Tumors

Trial ID

NCT05763004

Cancer type

 Solid tumours

Status

Open and recruiting

Phase

Phase one: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one clinical trial is to test the safety of the new treatment and find the best dose to give patients. 

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.

Title

A Phase 1/2a Open-Label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Mirdametinib in Combination With BGB-3245 in Patients with Advanced Solid Tumors

Trial ID

NCT05580770

Cancer type

Solid tumours

Status

Upcoming 

Phase

Phase one / two: A phase one / two clinical trial combines a phase one and two. The phase one tests new treatments sometimes for the first time in humans, usually in a small group of patients. The phase two part tests the new treatment in a larger group of patients with selected cancer types. The aim of a phase one / two is to find the best dose of the new treatment and see if it works against the cancer

Who can participate

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

For full inclusion / exclusion criteria refer to the Australian Cancer Clinical Trial Registry.