Oncology clinical trials at Subiaco

CAMBRIA-01

A Phase III Study in ER+/HER2- Early Breast Cancer after at least 2 years of standard adjuvant endocrine therapy with or without CDK4/6 inhibitor (Protocol no. D8531C00002)

https://clinicaltrials.gov/study/NCT05774951

PI: Dr Daphne Tsoi

CAMBRIA-02

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease (Protocol no. D8535C00001)

https://clinicaltrials.gov/study/NCT05952557

PI: Dr Daphne Tsoi

EmpowHER-303

A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment (Protocol # JZP598-303-01)

https://clinicaltrials.gov/study/NCT06435429

PI: Dr Daphne Tsoi

KAT6i

Study of PF-07248144 in Advanced or Solid Tumours (NCT04606446)

https://clinicaltrials.gov/study/NCT04606446

PI: A/Prof Tim Clay - recruitment currently on hold.

OPTIMA

Optimal Personalised Treatment of Early Breast Cancer using Mutli-parameter Analysis (Protocol BCT 2202)

https://www.isrctn.com/ISRCTN42400492

PI: A/Prof Tim Clay

GLORIOSA

Randomized, Multicentre, Open-Label, Phase 3 Study Of Mirvetuximab Soravtansine In Combination With Bevacizumab Versus Bevacizumab Alone As Maintenance Therapy For Patients With FR-positive Recurrent Platinum-Sensitive Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-Based Chemotherapy Plus Bevacizumab (Protocol IMGN853-0421)

https://clinicaltrials.gov/study/NCT05445778

PI: Dr Andrew Dean

ZN-c3-005

A Phase 2 Open-Label, Multicentre Study to Evaluate Efficacy and Safety of ZN-c3 in Subjects with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

https://clinicaltrials.gov/study/NCT05128825

PI: A/Prof Tarek Meniawy – recruitment currently on hold.

BGB-LC-201

A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer

https://clinicaltrials.gov/study/NCT05635708

PI: A/Prof Tim Clay - recruitment currently on hold.

BEAMION-LUNG02

A Phase III, open-label, randomised, active-controlled, multi-centre trial evaluating orally administered BI 1810631 compared to standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic non-squamous non–small cell lung cancer harbouring HER2 tyrosine kinase domain mutations

https://clinicaltrials.gov/study/NCT06151574

PI: A/Prof Tim Clay

IDeate-LUNG02

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician’s Choice (TPC) in Subjects with Relapsed Small Cell Lung Cancer (SCLC)

https://clinicaltrials.gov/study/NCT06203210

PI: A/Prof Tim Clay

TROPION-LUNG15

A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants with EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer whose Disease has Progressed on Prior Osimertinib Treatment

https://clinicaltrials.gov/study/NCT06417814

PI: A/Prof Tim Clay

Beamion PANTUMOR-1

A Phase II, multicenter, multi-cohort, open-label trial to evaluate the efficacy and safety of oral zongertinib (BI 1810631) for the treatment of selected HER2-mutated or overexpressed/amplified solid tumors

https://clinicaltrials.gov/study/NCT06581432

PI: A/Prof Timothy Clay

IDeate-PANTUMOUR02

A Phase 1b/2 Pan-tumor, Open-label Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I‑DXd) in Subjects with Recurrent or Metastatic Solid Tumors

https://clinicaltrials.gov/study/NCT06330064

PI: A/Prof Timothy Clay

MODERNA (mRNA-4157)

A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA and Pembrolizumab Alone After Complete Resection of High-Risk Melanoma (Protocol no. mRNA-4157-P201)

https://clinicaltrials.gov/study/NCT03897881

PI: A/Prof Tarek Meniawy

iLSTA

A Phase 1 safety run-in study of CEND-1 in combination with durvalumab, gemcitabine and nab-paclitaxel as a first-line treatment in locally advanced pancreatic adenocarcinoma (Protocol # ESR-21-21433)

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385399

PI: Dr Andrew Dean

FOENIX-CCA4

Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements

https://clinicaltrials.gov/study/NCT05727176

PI: Dr Thomas van Hagen

SPADE

Asia Pacific Avelumab bladder cancer maintenance

PI: A/Prof Timothy Clay