ONGOING (NOT RECRUITING)

BREAST CANCER

Phase II: XENERATM1: BI1280-0022 (Boehringer Ingelheim)

A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase 2 Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease.
Adult female patients with locally advanced or metastatic brest cancer who are not deemed amenable to curative surgery or curative radiation therapy are eligible to take part in this clinical trial. The histologically confirmed breast cancer wih ER nad /or PgR positive and HER2 negative should be progressed during or within 12 months of completion of endocrine adjuvant therapy.

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Phase III: DS8201-A-U301 (Daiichi Sankyo, Inc.)

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator’s Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
This study will compare DS 8201a to standard treatment. Patients must have HER2 breast cancer that has been treated before. Moreover, their cancer cannot be removed by an operation and has spread to other parts of the body.

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Phase III: DS8201-A-U302 (Daiichi Sankyo, Inc.)

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane.
This study will compare DS 8201a to standard treatment. Patients must have HER2 breast cancer that has been treated before. Moreover, their cancer cannot be removed by an operation and has spread to other parts of the body.

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LYMPHOMA

Phase II: R1979-ONC-1625 (Regeneron Pharmaceuticals)

An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.
Primary objective of this study is to assess the anti-tumor activity of single agent odronextamab in patients with follicular lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma, and other B-NHL subtypes.

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GASTRO INTESTINAL TUMOURS

Phase I/Ib: AB928CSP0003 (Arcus Biosciences, Inc.)

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Gastrointestinal Malignancies.
This study evaluates the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with mFOLFOX in participants with advanced metastatic gastroesophageal Cancer (GEC) or colorectal cancer (CRC).

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PROSTATE CANCER

Phase II: TRITON2: CO-338-052 (Clovis Oncology, Inc.)

A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency.
The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib. The participant should be medically or surgically castrated and have experienced disease progression on prior systemic therapies.

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UROTHELIAL CANCER

SOLID TUMOURS

Phase I/II: CA030001 (Bristol-Myers Squibb)

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors.
The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.

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Phase I: M15-862 (AbbVie)

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors.
This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumours.

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Phase I: DESIGNER EDV: ENG8 (EnGeneIC Pty Limited)

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-60mer) in Subjects with Advanced Solid Tumours who have No Curative Treatment Options.

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Phase I: CS3002-101 (CStone Pharmaceuticals)

A Phase 1, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activities of CS3002, a CDK4/6 Inhibitor, in Subjects With Advanced Solid Tumors.

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Phase I: CS3005-101 (CStone Pharmaceuticals)

A Phase 1, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects With Advanced Solid Tumors.
This study recruite patients who have confirmed advanced solid tumor and have progressed disease and/or experienced intolerance from prior standard therapies, or for whom no standard of care (SoC) therapies exist.

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Phase I/II: ARTISTRY-1: ALKS4230-A101 (Alkermes, Inc.)

A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors.
This study is designed to assess the safety and tolerability of ALKS 4230, and assess the anti-tumour activity of ALKS 4230 in Monotherapy and ALKS 4230 in Combination with pembrolizumab.

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OVARIAN

Phase III: SORAYA: IMGN853-0417 (ImmunoGen, Inc.)

A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression.
This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in patients with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy.

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