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.

 

RAGNAR  42756493CAN2002

Registered Title  A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations
Purpose  The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) mutations and gene fusions.
Lay Summary  N/A
WA Trial Sites  Cancer Centre Clinical Trials Unit Ph. 08 615 26530
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

 

YH003002

Registered Title  A Multicenter, Open-Label, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of YH003 in combination with Toripalimab (anti-PD-1 mAb) in Subjects with Advanced Solid Tumors
Purpose The main purposes of this study are to assess the safety, tolerability, preliminary efficacy and PK of YH003 in combination with anit-PD-1 mAb Toripalimab in subjects with advanced solid tumors in dose escalation and to explore the preliminary efficacy of YH003 in combination with Toripalimab with or without chemotherapy in subjects with unresectable metastatic melanoma and pancreatic ductal adenocarcinoma in the cohort expansion.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

EVX-02-001

Registered Title  A Phase 1/2, Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1 After Complete Resection of Stage IIIB/IIIC/IIID or Stage IV Melanoma in Patients at High Risk for Recurrence.
Purpose  This is a Phase 1/2, open label, multi-centre study to assess the safety, tolerability, PD,
and efficacy of adjuvant immunotherapy EVX-02 vaccine and anti-PD-1 (Nivolumab) in patients
who have had a complete resection of a Stage IIIB/IIIC/IIID or Stage IV melanoma who are at
high risk of recurrence.
Lay Summary  N/A
WA Trial Sites Linear Clinical Research ph. 08 6382 5513 
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

SHR-1701-001AUS

Registered Title A Phase 1, Open-Label, Multi-Center, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SHR-1701 in Subjects With Advanced Solid Tumors.
Purpose  This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and
tolerability of SHR-1701 in subjects with advanced solid tumors.
Lay Summary This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase 1 study of repeated doses of SHR-1701 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies.
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

AIS B01

Registered Title An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1)
Purpose  This is a cohort-based, open-label dose escalation and expansion study in adults with
advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without
available standard or curative therapy.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CS1001

Registered Title A Phase Ib/II, Multicenter Open-label Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors
Purpose  This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment
effect of CS1001 in combination with regorafenib in patients with advanced or refractory
cancers.
Lay Summary  N/A
WA Trial Sites  Ph. (08) 6465 9204
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

LIBRETTO-201

Registered Title Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
Purpose  Expanded access for patients with cancer with RET activation who are ineligible for an
ongoing LOXO-292 clinical trial or have other considerations that prevent access to LOXO-292 through an existing clinical trial.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

R3767-ONC-1613

Registered Title  A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (Anti-LAG-3 mAb) Administered Alone or in Combination With REGN2810 (Anti-PD-1 mAb) in Patients With Advanced Malignancies.
Purpose The primary objectives in the dose escalation phase are to evaluate safety and
pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of
REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced
malignancies, including lymphoma.

The primary objectives in the dose expansion phase are to assess preliminary anti-tumor
activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as
measured by objective response rate (ORR)."

Lay Summary  N/A
WA Trial SItes  SCGH Medical Oncology Ph. (08) 6383 3000
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

MoST Addendum 4

Registered Title Single arm, open label, signal seeking, phase IIa trial of the activity of vismodegib in patients with tumours harbouring PTCH1 or SMO mutations
Purpose This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of vismodegib in patients with advanced cancers and tumours.
Lay Summary  You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any cell type or an earlier diagnosis of a poor prognosis cancer and have received all standard anticancer therapy. Participants will have tumours with mutations in PTCH1 or SMO.
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links  Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

CA224-048

Registered Title A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors 
Purpose  The purpose of this study is to investigate safety and anti-tumor activity of relatlimab combination therapy in solid cancers that are advanced or have spread
Lay Summary  N/A
WA Trial Sites

 Linear Clinical Research ph. 08 6382 5513

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

FPT155-001

Registered Title   A Phase 1a/1b Safety and Tolerability Study of FPT155 in Patients with Advanced Solid Tumors.
 Purpose The purpose of this study is to assessment the safety and tolerability of a new medication called FPT155.
 Lay Summary  N/A
 WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

ABN401-001

Registered Title A Phase 1-2 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors
Purpose This is a dose escalation, Phase 1-2 study of ABN401 in patients with advanced solid tumors,refractory metastatic disease, or refractory locally advanced disease not amenable to local therapy.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

IN10018-004-01

Registered Title A Phase Ib, Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of IN10018 as Monotherapy and Combination Therapy in Subjects With Metastatic Melanoma
Purpose  This is a phase Ib, open label clinical study to evaluate the safety, tolerability, PK and
antitumor activities of IN10018 as monotherapy and in combination with cobimetinib in
subjects with metastatic uveal melanoma and NRAS-mutant metastatic melanoma.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links US National Library of Medicine
Acknowledgements: US National Library of Medicine

 

BGB-A317-A445-101

Registered 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
Purpose  This is a phase Ib, open label clinical study to evaluate the safety, tolerability, PK and
antitumor activities of IN10018 as monotherapy and in combination with cobimetinib in
subjects with metastatic uveal melanoma and NRAS-mutant metastatic melanoma.
Lay Summary  N/A
WA Trial Sites 

 Linear Clinical Research ph. 08 6382 5513

Links  US National Library of Medicine
Acknowledgements: US National Library of Medicine

 

Maxinovel-10181-001

Registered Title A Phase I Study of MAX-10181 Given Orally to Patients With Advanced Solid Tumor
Purpose  This is a multi-center, first-in-human, non-randomized, open-label, single-arm,
dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in
patients with advanced solid tumor.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

BGB-900-105

Registered Title Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Purpose  BGB-A1217 is a humanized, IgG1 monoclonal antibody against TIGIT. Tislelizumab is a
humanized, IgG4-variant monoclonal antibody against PD-1. This study tests the safety and
anti-tumor effect of BGB-A1217 in combination with tislelizumab in patients with advanced
solid tumors.
Lay Summary N.A
WA Trial Sites

 Linear Clinical Research ph. 08 6382 5513

Links  US National Library of Medicine
Acknowledgements: US National Library of Medicine

 

MK-7339-007 /KEYLYNK-007

Registered Title  A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer
Purpose  The purpose of this study is to assess the efficacy and safety of treatment with olaparib
(MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated,
advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm)
and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.
Lay Summary  N/A
WA Trial Sites Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine
Acknowledgements: US National Library of Medicine

 

THOR-707-101

Registered Title  An Open-Label, Multicenter Phase 1/2 Dose Escalation and Expansion Study of THOR-707 as a Single Agent and in Combination With a Checkpoint Inhibitor in Adult Subjects With Advanced or Metastatic Solid Tumors
Purpose This is an open-label, First-in-Human, dose escalation and dose expansion study of THOR-707
(Monotherapy and Combination Therapy) in adult subjects with advanced or metastatic solid
tumors.
Lay Summary  N/A
WA Trial Sites  Ph. (08) 6465 9204
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

204691

Registered Title  A Phase I Open Label Study of GSK3359609 Administered Alone and in Combination With Anticancer Agents in Subjects With Selected Advanced Solid Tumors.
Purpose 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 or GSK3174998 combination dose escalation phase and Part 2B expansion phase with pembrolizumab. 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 doseof GSK3359609 alone or in combination.
Lay Summary  N/A
WA Trial Sites Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine
Acknowledgements: US National Library of Medicine

 

FLX475-02

Registered Title  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer
Purpose This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort
expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as
monotherapy and in combination with pembrolizumab.

The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort
expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential
cohorts treated with successively higher doses of FLX475 as monotherapy or in combination
with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of
parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

Lay Summary  N/A
WA Trial Sites

Linear Clinical Research ph. 08 6382 5513

Links US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

BGB-900-102

Registered Title Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Purpose This study tests the safety and anti-tumor effect of BGB-A425 in combination with tislelizumab in patients with advanced solid tumors.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

BGB-900-103

Registered Title A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Purpose This is an open-label, multicenter, non-randomized Phase 1b clinical trial for patients with histologically or cytologically confirmed locally advanced or metastatic tumors including non- squamous NSCLC, RCC, or OC.
Lay Summary  N/A
WA Trial Sites Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

MK-7339-002 / LYNK-002

Registered Title A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer
Purpose This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in
participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1)
have progressed or been intolerant to standard of care therapy; and 2) are positive for
homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD).
Lay Summary  N/A
WA Trial Sites

 Linear Clinical Research ph. 08 6382 5513

LInks  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

BGB-283/PD-0325901-AU-001

Registered 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
Purpose  This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 combination in
patients with tumors.
Lay Summary  N/A
WA Trial Sites

Linear Clinical Research ph. 08 6382 5513

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

AM-ATX101-01

Registered Title A phase 1 dose escalating study to determine incidence of dose limiting toxicities of single agent ATX-101 given by intravenous infusion every week in patients with advanced solid tumours
Purpose This is a Phase I, open-label, single arm, safety and tolerability study which will evaluate escalating dose cohorts of ATX-101 to determine the maximum tolerated dose in subjects with advanced solid tumours.
Lay Summary  N/A
WA Trial Sites

Linear Clinical Research Ph. 08 6382 5513

Links  Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

ARCS-Multi (BAY 94-9343)

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.
 Lay Summary N/A 
 WA Trial Sites

 Medical Oncology (08) 6383 3000

 LInks  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA224-020

Registered Title A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Purpose The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.
Lay Summary An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
WA Trial Sites

    Linear Clinical Research ph. 08 6382 5513

Links US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

P3BEP 

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 LogoCancer Centre Clinical Trials Unit   Ph.  08 615 26530 

Links

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

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 ph. 08 6382 5513

 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 ph. 08 6382 5513

 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 Ph. 08 6382 5513

 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 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 ph. 08 6382 5513

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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