Phase 1 and Other Cancers

The following list provides a brief description of Phase 1 and other cancer trials that are open for recruitment in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.

Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.

Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.

 

P3BEP Germ Cell Tumour Study

Registered Title

Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours.

Purpose

The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.

Lay Summary

Who is it for?

You may be eligible to join this study if you are a male aged 16 years to 45 years old and you have been diagnosed with metastatic germ cell tumour/s in the testes, retro-peritoneum or mediastinum.

Study details:

Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current gold standard treatment for germ cell tumours, which is a chemotherapy combination called BEP (bleomycin, etoposide and cisplatin) administered on a 3 weekly cycle. BEP is given with a drug called pegfilgrastim which encourages white blood cell production and prevents blood cell complications of chemotherapy. Participants in the other group will receive the same dose of BEP but on a 2 weekly schedule. This is called 'accelerated BEP'.

WA Trial Sites

Fiona Stanley Hospital Logo

Cancer Centre Clinical Trials Unit
Caroline Stone
Clinical Trials Manager
Phone 08 615 26530 Fax 08 615 20954
caroline.stone@health.wa.gov.au

Links

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry


BGB COMBO

Registered Title
 A Phase 1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid Tumors
 Purpose  The Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid Tumors
 Lay Summary
 N/A
 WA Trial Sites

Linear Clinical Research 0437 873 044

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA017-003

Registered Title
 A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (BMS-936558, Anti-PD-1 Monoclonal Antibody) in Advanced Malignant Tumors
 Purpose The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.
 Lay Summary
 N/A
 WA Trial Sites

Linear Clinical Research 0437 873 044

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

SHR3162-002

Registered Title A Phase I Trial of SHR3162 in Subjects With Advanced Solid Tumors
Purpose  This is an open-label, multicenter, non-randomized, dose-escalation phase 1 trial to evaluate the safety and tolerability of SHR3162 in participants with advanced solid tumors.
Lay Summary  N/A
WA Trial Sites

 

Linear Clinical Research 0437 873 044

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CBT-501-01

 Registered Title
 A Phase 1 Multicenter, Dose Escalation Study of CBT-501 in Subjects With Select Advanced or Relapsed/Recurrent Solid Tumors
 Purpose  The purpose of this study is to determine the safety, tolerability, and recommended dose schedule of CBT-501 in individuals with advanced or relapsed or recurrent solid tumors.
 Lay Summary
N/A
 WA Trial Sites

Linear Clinical Research 0437 873 044

 Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

AK104-101

Registered Title
 A Phase 1A/1B Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK104 in Subjects With Advanced Solid Tumors
 Purpose  This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK104 as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK104 as a single agent, and a dose expansion phase (Phase 1b) which will characterize treatment of AK104 as a single agent at the MTD or RP2D.

 Lay Summary

 N/A
 WA Trial Sites

Linear Clinical Research 0437 873 044

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

INCAGN1876-102

Registered Title
A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
 
 Purpose  The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.
 Lay Summary
 N/A
 WA Trial Sites

Linear Clinical Research 0437 873 044

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

SHR1316-002

Registered Title
 A Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Solid Tumors
 Purpose In many types of human tumors, PD-L1 is highly expressed. Such high expression has often been associated with poor prognosis in cancer patients. SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.
 Lay Summary
 This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase I study of repeated doses of SHR-1316 (1, 3, 10, 15, and 20 mg/kg [with the option for 30 and 40 mg/kg]) in subjects with advanced or metastatic solid tumors who have failed current standard anti-tumor therapies
 WA Trial Sites

Linear Clinical Research 0437 873 044

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA020-002

Registered Title
Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumours
 Purpose The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself and in combination with Nivolumab in solid cancers that are advanced or have spread.
 Lay Summary
 N/A
 WA Trial Sites

Linear Clinical Research 0437 873 044

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

I8S-MC-JUAB

Registered Title
A Phase 1 Study of an ERK1/2 Inhibitor (LY3214996) Administered Alone or in Combination With Other Agents in Advanced Cancer
Purpose The purpose of this study is to determine the safety of an extracellular signal regulated kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in participants with advanced cancer.
Lay Summary
 N/A
 WA Trial Sites

Linear Clinical Research 0437 873 044

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

GSK204691

 Registered Title

A Phase I Open Label Study of GSK3359609 Administered Alone and in Combination With Anticancer Agents in Subjects With Selected Advanced Solid Tumours

 Purpose  GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in subjects with advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab combination dose escalation phase and Part 2B cohort expansion phase. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.
 Lay Summary
 N/A
 WA Trial Sites

Linear Clinical Research 0437 873 044

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

EMR200647

 Registered Title
A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability,Pharmacokinetics, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications
 Purpose  The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.
 Lay Summary
 N/A
 WA Trial Sites

Linear Clinical Research 0437 873 044

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

BGB-290-AU-002

Registered Title
 A Phase IA/IB, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Food Effect, and Antitumor Activities of BGB-290 in Subjects With Advanced Solid Tumors
 Purpose  This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-290 in patients with solid tumors.
 Lay Summary
 N/A
 WA Trial Sites

 Linear Clinical Research 0437 873 044

 Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

CP-MGD009-01

 Registered Title
 Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients With Unresectable or Metastatic B7-H3-Expressing Neoplasms
 Purpose  The purpose of this study is to evaluate the safety of MGD009 when given to patients with B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that can be given safely. Assessments will be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity of MGD009.
 Lay Summary
 N/A
 WA Trial Sites

 

Linear Clinical Research 0437 873 044

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CS3006-101

Registered Title
 A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, PK and Antitumor Activities of the MEK Inhibitor CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors
Purpose  This is a multicenter, open label, dose escalation & expansion phase I study to evaluate the clinical safety, tolerability, PK, and preliminary efficacy of CS3006.
Lay Summary
 N/A
WA Trial Sites

Linear Clinical Research 0437 873 044

Links
US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

Bayer ARCS-Multi

Registered Title Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies
Purpose The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.

The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.

Lay Summary  N/A
WA Trial Sites

St John of God - Subiaco (08) 6465 9204

Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

PIN-017-Q3

Registered Title "A Phase 1a study to investigate the immunogenic potential of PIN-2 administered
intravenously to patients with advanced solid tumors"
Purpose  The purpose of this study is to investigate whether a new drug called PIN-2 is safe and activates the immune system in patients with advanced solid tumours.
Lay Summary

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have a histologic diagnosis of an advanced solid tumor.

Study details
All participants in this study will receive one cycle of chemotherapy treatment with the drug, PIN-2 (Precision Immune Stimulants). PIN-2 will be administered intravenously (i.e. directly into the vein) 3 x per week for 2 weeks followed by a one week rest period. If tolerated and deemed beneficial, a second identical course may be administered. No more than 2 courses in total will be given.

Participants will be regularly monitored for safety, and asked to provide a number of blood samples across a 5 week period to assess how the body processes and responds to the drug. Tissue samples (tumor and/or lymph node) will also be obtained, if possible, at pre-treatment and again at the conclusion of each treatment cycle for evaluation. Patients who are eligible for and agree to participate in the biopsy will have tumor biopsy prior to treatment and at week 3.

This study will help find new methods of treatment for the patients with solid tumors.

WA Trial Sites

 

Linear Clinical Research 0437 873 044

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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