OPEN FOR RECRUITMENT

BREAST CANCER

Phase I/Ib: AB928CSP0002 (Arcus Biosciences, Inc.)

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Breast or Gynaecologic Malignancies.
Breast cancer patients with locally advanced or metastatic triple negative molecular character (ER-negative, PgR-negative, and HER2-negative according to ASCO/CAP guidelines) and Ovarian cancer patients with locally advanced or metastatic ovarian cancer that is platinum-resistant can take part in this trial. The patients should have disease progressed after no more than 3 prior lines of therapy.

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Phase III: IMPASSION 030: WO39391 (Hoffmann-La Roche)

A Phase 3, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination with Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients with Operable Triple Negative Breast Cancer.
This study will evaluate the efficacy, safety and pharmacokinetics of adjuvant atezolizumab in combination with other chemotherapy options. This study is recruiting patients with non-metastatic operable Stage II-III histologically confirmed triple negative breast cancer. Patients must have undergone either breast-conserving surgery or mastectomy/nipple -or skin-sparing mastectomy.

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Phase III: WO41554 (Hoffmann-La Roche)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GDC-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients with PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer.
This study will evaluate the efficacy, safety, and pharmacokinetics of GDC-0077 in combination with other anticancer therapies (palbociclib and fulvestrant) in patients with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

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Phase II: CAPTURE: BCT 1901 (Breast Cancer Trials)

A phase 2 randomised study to evaluate alpelisib plus fulvestrant versus capecitabine in oestrogen receptor positive, HER2-negative advanced breast cancer patients with PIK3CA mutant circulating DNA.
This study aims to find out whether treatment with alpelisib plus fulvestrant increases progression-free survival compared to capecitabine in women and men with eostrogen receptor positive (ER+), HER2-negative advanced breast cancer who have a PIKC3A mutation identified in circulating tumour DNA (ctDNA)

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Phase Ib: CYH33-G103 STUDY (Haihe Biopharma Co., Ltd.)

A Multicenter, Open-label, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer. This clinical trial is to evaluate the safety, tolerability, and effect of oral CYH33 in combination with standard-of-care for the treatment of locally advanced, recurrent or metastatic HR positive (HR+), HER2 negative (HER2-) breast cancer.

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WO41554

A Phase III Randomized, Double-Blind, Placebo-Controlled study for treatment of PIK3CA-mutant, HR+, HER2- locally advanced / metastatic breast cancer where disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and no prior systemic therapy.

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CAPTURE BCT 1901

A Phase II Randomized study in ER+, HER2- advanced breast cancer patients with PIK3CA mutant circulating DNA. No prior capecitabine.

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CYH33-G103 Tigermed

A Phase Ib Study in Patients with PIK3CA Mutant, Hormone Receptor-positive (HR+), Human Epidermal Growth Factor Receptor 2-negative (HER2-) Advanced Breast Cancer

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ACE-BREAST-03

A Global, Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients whose Disease is Resistant or Refractory to T-DM1, and/or T-DXd, and/or Tucatinib-containing Regimens

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OP-1250-002 Olema Pharmaceuticals, Inc.

A Phase I/II Open-label, First-in-Human, Multicenter, Dose Escalation and Dose Expansion Study of OP-1250 Monotherapy in Adult Subjects With Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer

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OVARIAN CANCER

No Current Active Trial – Contact the Clinical Trials Department for further enquires. Phone: (03) 9781 5244 or ag@paso.com.au

GASTRO INTESTINAL TUMOURS

The PROOF Study QBGJ398-301

A Phase III Randomized, Open-Label study for first line treatment of unresectable locally advanced/metastatic cholangiocarcinoma with FGFR2 gene fusions/translocations.

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YH003004

A Multi-center, Open-label Phase II Study to Evaluate the Safety and Efficacy of YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Patients With Unresectable/Metastatic Melanoma and Pancreatic Ductal Adenocarcinoma (PDAC)

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LUNG CANCER

LIBRETTO-431 J2G-MC-JZJC

A Phase III Randomized, Open-Label first line therapy for RET fusion-positive non-small cell lung cancer.

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DREAM3R CTC 0231/ALTG18/001/PrE0506

A Phase III first line chemotherapy with cisplatin and pemetrexed for advanced pleural Mesothelioma.

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Apollomics APL-101-01 SPARTA

Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

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GS-US-577-6153

Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

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EARLI-001-CT01

A Phase 1, open label, single dose, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of EARLI-001 in subjects with locally advanced or metastatic lung cancer or subjects with metastases in the lung or liver of a primary cancer origin other than lung cancer

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AdvanTIG-205 BeiGene

A Phase II, Randomized, Double-blind Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Metastatic NSCLC Without Sensitizing EGFR or ALK Mutations who have Received No Previous Treatment for Metastatic Disease

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MYELODYSPLASTIC SYNDROME (MDS)

No Current Active Trial – Contact the Clinical Trials Department for further enquires. Phone: (03) 9781 5244 or ag@paso.com.au

PANCREATIC CANCER

No Current Active Trial – Contact the Clinical Trials Department for further enquires. Phone: (03) 9781 5244 or ag@paso.com.au

LYMPHOMA

R1979-ONC-1625

A Phase II Open Label third line treatment for Relapsed or refractory B cell-Non-Hodgkin lymphomas relapsed after or is refractory to prior systemic therapy

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APG-2575CU1001

A Phase Ib/II single agent or combination study for elapsed / refractory Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma

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ETH-155008-101

A Phase 1a/1b First-in-human, Study in Subjects with Relapsed or Refractory B-cell NHL, CLL/SLL and AML.

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TigerMed GB261-001

A Phase I/II, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GB261 in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

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PROSTATE CANCER

TRITON3 CO-338-063

A Phase III Randomized, Open Label study of rucaparib versus physician’s choice of therapy for patients with metastatic castration-resistant prostate cancer associated with homologous recombination deficiency

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CheckMate 7DX CA2097DX

A Phase III Randomized, Doubel-Blind first line therapy for metastatic castration-resistant Prostate cancer (mCRPC)

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Aranote BAY 1841788 / 21140

A Phase III randomized, double-blind, placebo-controlled study of darolutamide in men with metastatic hormone-sensitive prostate cancer (mHSPC)

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UROTHELIAL CANCER

THOR 42756493BLC3001

A Phase III second line therpay for Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

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RENAL

D7980C0003

A Phase 1b, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combination with Axitinib in Subjects with Advanced Renal Cell Carcinoma

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SOLID TUMOURS

Phase I: PTX-100-PD-012017 (Prescient Therapeutics, Ltd.)

Phase 1 Pharmacodynamic and Pharmacokinetic Study of the Geranylgeranyltransferase I Inhibitor PTX-100 (GGTI-2418) in Patients With Advanced Malignancies.
Patients with multiple myeloma, peripheral T-cell lymphoma, colorectal cancer, pancreatic cancer, or diffuse gastric cancer who have a relapsed or refractory advanced malignancy for which no standard therapy exists are the subjects for this trial.

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Phase II:SGNLVA-005 (Seagen Inc.)

Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors.
This trial will study ladiratuzumab vedotin (LV) to find out if it works to treat different types of solid tumors including Small Cell Lung Cancer
Squamous / Non-squamous Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Prostate Cancer and Melanoma.

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Phase I: SHR-A1811-I-101 (Jiangsu HengRui Medicine Co., Ltd.)

A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects

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Phase I/II: EMB02X101 (Shanghai EpimAb Biotherapeutics Co., Ltd.)

Phase 1, Multicenter, First-in-Human Dose Escalation Study of ALMB-0168 Administered IV as a Single Agent to Patients with Malignant Bone Disease
The purpose of this study is to test the safety of a new medication (called ALMB-0168) in people with malignant bone cancer lesions either from bone cancer or from migration of other cancers.

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Phase I: YH002002 (Eucure (Beijing) Biopharma Co., Ltd)

A First-in-Human (FIH), Multicenter, Open-Label, Phase 1 Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of YH002 in Subjects With Advanced Solid Malignancies

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Phase I/II: D1553-101 (InventisBio Shanghai Limited)

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects with Advanced or Metastatic Solid Tumors with KRasG12C Mutation

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Phase I: LM061-01-102 (LaNova Medicines Ltd.)

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects with Advanced or Metastatic Solid Tumors with KRasG12C Mutation

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YH002004

A Multicenter, Open-label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YH002 in Combination With YH001 in Subjects With Advanced Solid Tumors

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YH003005

A Multicenter, Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the Combination of YH003, YH001 and Pembrolizumab in Subjects With Advanced Solid Tumors

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ICP-CL-00303

A Multi-center Open-label, Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-192 in Patients With Advanced Solid Tumors and FGFR Gene Alterations

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SHR-1501-I-101

A Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of SHR-1501 in Combination with SHR-1316 in Patients with Advanced Malignancies

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ADG116-1003

A Phase 1b, Open-Label, Dose Escalation and Expansion Study of ADG116, ADG116 Combined With Toripalimab (Anti-PD-1 Antibody), ADG116 Combined With ADG106 (Anti-CD137 Antibody) in Patients With Advanced/Metastatic Solid Tumors

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LM302-01-201

A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM302 in Combination with Toripalimab in Patients with Advanced Solid Tumors

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SHR-A1811-I-101

A Phase I study in HER2 Expressing or Mutated Advanced Malignant Solid tumour Subjects.

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TCTLR-101

Phase 1/2 Study of TransCon TLR7/8 Agonist, Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies

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CL001_559

A Phase 1 first in human, multicenter, open-label study to determine the safety, tolerability, pharmacokinetics, and recommended Phase 2 dose of ccx559 in subjects with solid tumors

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ABSK043-101

A Phase 1, Open-Label Study of ABSK043 to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced Solid Tumor

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RC118-G001

Phase 1, First-in-Human, Multicentre, Open-label Study of RC118 for Injection in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours

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