OPEN FOR RECRUITMENT

BREAST CANCER

PHASE II: XENERA-1 BI1280-0022 STUDY

A multi-centre, double-blind, placebo-controlled, randomised phase II trial to compare efficacy of xentuzumab in combination with everolimus and exemestane versus everolimus and exemestane in post-menopausal women with HR+ / HER2-metastatic breast cancer and non-visceral disease.

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PHASE I: ARCUS AB928CSP0002 STUDY

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Breast or Gynaecologic Malignancies.

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PHASE III: IMPASSION 030 WO39391 STUDY

A Phase III, Multicentre, Randomized, Open-label Study Comparing

ATEZOLIZUMAB (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy vs Chemotherapy Alone in Patients with Operable Triple-Negative Breast Cancer

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 PHASE III: DAIICHI SANKYO DS8201-A-U301 STUDY

A Phase 3, multicentre, randomized, open-label, active-controlled study of DS-8201a, an anti-HER2-antibody drug conjugate, versus treatment of investigator’s choice for HER2-positive, unresectable and/or metastatic breast cancer subjects pre-treated with prior standard of care HER2 therapies, including T-DM1.

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 PHASE III: DAIICHI SANKYO DS8201-A-U302 STUDY

A Phase 3, multicenter, randomized, open-label, active-controlled study of DS-8201a, an anti-HER2-antibody drug conjugate, versus ado-trastuzumab emtansine (T-DM1) for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

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GASTRO INTESTINAL TUMOURS

PHASE III BOSTON CANSTEM303C CRC STUDY

A Phase III Study of BBI-608 in combination with 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients with Previously Treated Metastatic Colorectal Cancer (CRC)

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 PHASE I: ARCUS AB928CSP0003 STUDY 

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Gastrointestinal Malignancies.

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 PHASE III: SOLSTICE (CL3-95005-006) STUDY

An open-label, randomised, phase III Study comparing trifluridine/tipiracil (S 95005) in combination with bevacizumab to capecitabine in combination with bevacizumab in first-line treatment of patients with metastatic colorectal cancer who are not candidate for intensive therapy

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COLORECTAL CANCER

PHASE II: PROTOCOL NUMBER AGITG AG1013GST

A randomised phase II trial of imatinib alternating with regorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST).

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PHASE III: BOSTON CANSTEM303C CRC

A phase III study of BBI-608 in combination with 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in adult patients with previously Treated Metastatic Colorectal Cancer (CRC)

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GASTRIC AND GASTRO-ESOPHAGEAL JUNCTION CANCER

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LUNG CANCER

PHASE III: RESILIENT – IPSEN MM-398 STUDY

A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) versus Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed on or after Platinum-based First-Line Therapy

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PHASE II: TAKEDA BRIGATINIB-2002 STUDY 

Brigatinib in Patients with Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non–Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

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MYELODYSPLASTIC SYNDROME (MDS)

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PANCREATIC CANCER

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LYMPHOMA

PHASE I: HMPL-523 HUTCHISON STUDY

A Phase I, open-label, dose-escalation study of the safety and pharmacokinetics of HMPL-523 in patients with relapsed or refractory Hematologic Malignancies

PROSTATE CANCER

PHASE II: CO-338-052 TRITON2 STUDY 

A Multicentre, Open-label Phase 2 Study of Rucaparib in Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency.

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PHASE III: CO-338-063 TRITON3 STUDY

A Multicentre, Randomized, Open-label Phase 3 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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UROTHELIAL

PHASE III: 42756493BLC3001 THOR STUDY

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations


PHASE II: MK-3475-057STUDY 

A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects with High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy.

SOLID TUMOURS

PHASE I: ABBVIE M15-862 STUDY

A Multicentre, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927, an Immunotherapy, in Subjects with Advanced Solid Tumours


PHASE I: EnGeneIC ENG8 DESIGNER EDV STUDY 

A Phase 1 Study of Anti-Human EGFR (Vectibix Sequence) Targeted EDVTMs Carrying the Cytotoxic Drug PNU-159682 (EGFR(V)-EDV-PNU) with Concurrent Non-Targeted EDVs Carrying an Immunomodulatory Adjuvant (EDV-40mer) in Subjects with Advanced Solid Tumours who have No Curative Treatment Options.


PHASE I / II: BMS CA030001 STUDY

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumours.


PHASE I / IIa: EnGeneIC CAROLYN ENG 9 STUDY

A Phase I/IIa Study of EGFR-Targeted EDVTMs Carrying the Cytotoxic Drug PNU-159682 (E-EDV-D682) with Concurrent Immunomodulatory Adjuvant Non-Targeted EDVs carrying α-galactosyl ceramide (EDV-GC) in (i) Cohort 1, Subjects with Advanced Pancreatic Cancer and (ii) Cohort 2, Subjects with other EGFR Expressing Solid Tumours, who have Failed First or Second-line Therapy or where other Standard Therapies are not Appropriate


PHASE II: DEBIO 1347-201 FUZE STUDY

A Phase II basket study of the oral selective pan-FGFR inhibitor Debio 1347 in subjects with solid tumours harbouring a fusion of FGFR1, FGFR2 or FGFR3.

ONGOING (NOT RECRUITING)

BREAST CANCER

PHASE III: EMBRACA

A phase 3, open-label, randomized, parallel, 2-arm, multi-center study of talazoparib (BMN 673) versus physician’s choice in germline BRCA mutation subjects with locally advanced and/or metastatic breast cancer, who have received prior chemotherapy regimens for metastatic disease.

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PHASE III: PROTOCOL WO29522 IMPASSION130

A phase III, multicenter, randomized, placebo-controlled study of MPDL3280A (anti−PD-L1 antibody) in combination with nab-paclitaxel compared with placebo with nab-paclitaxel for patients with previously untreated metastatic triple-negative breast cancer.

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PHASE II EXTENSION STUDY : PROTOCOL TDM4529G/BO25430

This is a global, multicenter, open-label extension study. Patients receiving single-agent T-DM1 or combination T-DM1 administered in combination with paclitaxel or with pertuzumab ± paclitaxel in a Genentech/Roche-sponsored study who completed the parent study or who continue to receive study drug(s) at the time of the parent study closure are eligible for continued treatment on this protocol.

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PHASE II: PROTOCOL GO29689

A phase II, open-label, randomized study of GDC-0810 versus fulvestrant in postmenopausal women with advanced or metastatic ER+ /HER2 − breast cancer resistant to aromatase inhibitor therapy.

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PHASE III: ODONATE ODO-TE-B301 STUDY

A Multinational, Multicentre, Randomized, Phase 3 Study of Tesetaxel plus a Reduced Dose of Capecitabine versus Capecitabine Alone in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated with a Taxane.

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GASTRIC AND GASTRO-ESOPHAGEAL JUNCTION CANCER

PHASE III: PROTOCOL NUMBER GS-US-296-1080

A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of GS-5745 combined with mFOLFOX6 as first line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma.

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PHASE III: PROTOCOL NUMBER BBI608-336

A phase III randomized, double-blind, placebo-controlled clinical trial of BBI608 plus weekly paclitaxel vs. placebo plus weekly paclitaxel in adult patients with advanced, previously treated gastric and gastro-esophageal junction adenocarcinoma.

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COLORECTAL CANCER

PHASE III: PROTOCOL NUMBER GO30182

A phase III, open-label, multicentre, three-arm, randomized study to investigate the efficacy and safety of cobimetinib plus atezolizumab and atezolizumab monotherapy vs. regorafenib in patients with previously treated unresectable locally advanced or metastatic colorectal cancer.

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PHASE II: PROTOCOL NUMBER AGITG AG1013GST

A randomised phase II trial of imatinib alternating with regorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST).

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 PHASE III: BOSTON CANSTEM303C CRC

A phase III study of BBI-608 in combination with 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in adult patients with previously Treated Metastatic Colorectal Cancer (CRC)

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PROSTATE CANCER

PHASE III: ENZAMET ANZUP1304

A randomized phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer.

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Additional Information

UROTHELIAL CANCER

PHASE II: BL.12

A multicentre randomized phase II trial comparing nab-paclitaxel to paclitaxel in patients with advanced urothelial cancer progressing on or after a platinum containing regimen.

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SOLID TUMOURS

PHASE I: KN046-AUS-001 STUDY

An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of KN046 in Subjects with Advanced Solid Tumours.

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