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- Early drug development - phase one clinical trials
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 phase one cancer clinical trials, get in contact with our EDD team
Open and Recruiting Clinical Trials
GS-US-570-6015
A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GS-1811, an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti–PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
Trial ID
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 Clinical Trials Registry.
BG-C9074-101
Phase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Trial ID
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 Clinical Trials Registry.
BGB-3245-EFGR-001
A Phase 1a\1b Open-Label Study of BBO-8520 Monotherapy and BBO-8520 in Combination with Pembrolizumab in Subjects with Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer
Trial ID
Cancer type
Non-small cell lung cancer
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 Clinical Trials Registry.
Trial ID Cancer type Non-small cell lung cancer 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 ClinicalTrials.gov.
TBBO8520-101
A Phase 1a\1b Open-Label Study of BBO-8520 Monotherapy and BBO-8520 in Combination with Pembrolizumab in Subjects with Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer
Trial ID Cancer type Solid 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 ClinicalTrials.gov.
PRIMROSE
A Modular Phase I/IIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced/Metastatic Solid Tumours That are MTAP Deficient
Trial ID 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 ClinicalTrials.gov.
INCB 161734-101
A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors with KRAS G12D Mutation
Trial ID 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 ClinicalTrials.gov.
BGB-43395-101
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Combination Therapy in Patients with Metastatic HR+/HER2- Breast Cancer and other Advanced Solid Tumors
Trial ID 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 ClinicalTrials.gov.
GS-US-521-6317
A Phase 1 Study to Evaluate the Safety and Tolerability of GS9911, a DGKα Inhibitor, as Monotherapy and in Combination with an Anti-PD-1 Monoclonal Antibody in Adults with Advanced Solid Tumors
Trial ID 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 ClinicalTrials.gov.
GO44431
A phase I, open-label, dose-escalation study to evaluate the safety and pharmacology of RO7566802 administered with and without Atezolizumab in patients with locally advanced or metastatic solid tumors
Trial ID Cancer type Colorectal cancer 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.
CNA-3103-001
A Phase 1/2a, Multicenter, Open-Label, Dose Escalation and Expansion Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Adult Subjects with Metastatic Colorectal Cancer
Trial ID Cancer type Solid cancers Status Recruitment on hold 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.
BGB-A317-30813-101
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, nPharmacodynamics, and Preliminary Antitumor Activity of the DGKζ Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Solid Tumors
Trial ID Cancer type Solid 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 ClinicalTrials.gov.
CLAUDE
Phase I/IIa, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T with or without CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors
Trial ID Cancer type Solid 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.
INX-315-01
A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients with Advanced Cancer
Trial ID 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 ClinicalTrials.gov.
20220073
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects with Solid Tumor Indications
Trial ID 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.
IOS-1002-201
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 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.
EGRET
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 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.
AXA-042-FIH-01
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 inhibitors in subjects with advanced solid tumors.
Trial ID Cancer type Solid 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.
CERTIS1
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 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.
PROBE
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 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.
AMX-818-001
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 Patients with Locally Advanced or Metastatic HER2-Expressing Cancers
Trial ID Cancer type Solid cancers 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.
IMPARP-HRD
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 Cancer type Endometrial and ovarian cancer 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.
D6900C00001
A Phase I/IIa Multi-center, Open-label, Modular Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 as Monotherapy and in Combination with Anticancer Agents, in Participants with B7-H4 Expressing Advanced or Metastatic Solid Malignancies
Trial ID Cancer type Mesothelioma 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.
Vivace
Phase 1, Multi-Center, Open-Label, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VT3989 in Patients with Metastatic Solid Tumors Enriched for Tumors Harboring Mutations of the Neurofibromatosis Type 2 Gene (mutant NF2 or mNF2)
A Modular Phase I/IIa, Open-label, Multi-centre 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 Cancer type Solid 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.
PETRA
Trial ID Cancer type Solid Cancers with KRAS G12C Mutation 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.
GO42144
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 Cancer type Solid cancers 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 New Zealand Clinical Trials Registry.
MoST
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 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.
BGB-3245-AU-001
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 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.
BGB-283/PD-0325901-AU-001
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 a MEK inhibitor PD-0325901 in Patients with Advanced or Refractory Solid Tumors
If you don’t find what you are looking for or would like a center closer to home that may also provide similar clinical trials, refer to the Victorian Cancer Trials Link or Australian Clinical Trials Registry.