Early Phase Research

Early Phase Clinical Research Team (Clinical Pharmacology)

Our early phase clinical research team is one of the UK's leading research groups focusing on the early clinical development of novel cancer therapies.

The team, which is led by Dr Malcolm Ranson, is based on our Derek Crowther clinical trials unit (a unit specifically designed to conduct and support clinical trial activities), and comprises of research nurses, clinical support staff and administrative staff. Over 10 Phase I/II clinical trials are currently being conducted and a number are also in the pipeline.

Investigational therapies range from cytotoxic chemotherapy to new molecularly targeted agents (e.g. small molecule EGFR inhibitors, antisense agents, and monoclonal antibodies to HER2) administered both as single-agents and in combination.

Phase I/II trials may be offered to patients with advanced disease that is refractory to standard treatment or whose disease has progressed despite therapy. As such, these patients have limited treatment options available. Early phase trials aim to establish the safety and tolerability of experimental anticancer agents, determine a recommended dose and regimen for further studies, and also assess preliminary efficacy. The Team's exciting research programme also places a heavy emphasis on patient care and one-to-one support.

National and international collaborations include Cancer Research UK, major pharmaceutical companies and clinical research organisations. The Team also benefits from close links with the Paterson Institute for Cancer Research (PICR) and the Wolfson Molecular Imaging Centre (WMIC). The PICR provide key laboratory-based support for pharmacokinetic and pharmacodynamic analysis of study drugs and are leading an innovative biomarker research programme. The advent of mechanism-directed therapies that target tumour growth, proliferation, angiogenesis and apoptosis has promoted the development of functional imaging techniques to measure clinical activity, and the WMIC have an established positron emission tomography (PET) research initiative. By working with multidisciplinary groups, the early phase team works to validate the molecular pathways identified as potential therapeutic targets in the preclinical setting by establishing the safety and efficacy of novel agents in the clinical setting.

  • If you are a patient, please ask you GP or consultant about early phase trials; they will be able to offer you more information and advise you

Innovative Treatments Group

This group is lead by Professor Hawkins and undertakes a number of local, national and international clinical trials, with a particular focus on early phase trials in renal (kidney) and upper GI (oesophageal, gastric and pancreatic) cancers. The group has strong links with the Paterson Institute and Manchester University and the research undertaken there.

Most of our clinical trial activity is related to commercially sponsored trials. The close integration with the laboratory research groups within the department allows the development of a significant number of "in-house" trials that translate promising therapies from bench to clinic. Reflecting the research interests of the group, the majority of our trials are of novel gene or immunological therapies e.g. antibodies, genetic vaccines or cellular therapies.

The number and type of trials open to recruitment can change over time and each clinical trial has specific criteria for entry. Currently we are undertaking trials in the following conditions:

  • Advanced or metastatic renal cancer
  • Advanced gastric cancer
  • Advanced oesophageal cancer

A major focus of the group is cellular therapy, particularly T cell therapy and several phase I trials are in development. A GMP Cellular Therapy Unit at the National Blood Service in Manchester has been established.

The aim of T cell therapy is to modify a patients own T cells to target and destroy tumour cells. One such trial is currently open - depletion of regulatory T cells in patients with advanced renal cancer. Other phase I trials using genetically modified or engineered T cells to target CEA or CD19 +ve malignancies are due to open later in the summer this year.

Another strong interest is genetic vaccines and in particular 5T4 targeting. Phase I and II trials haven been completed and a Phase III trial is currently open.

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