Phase I Trials
Phase I trials are conducted at the Drug Development Unit at The Institute of Cancer Research. Dr Banerji works jointly with the Drug Development Unit (Professor Stan Kaye and Professor Johann de Bono), and the Cancer Research UK Centre for Cancer Therapeutics Unit (Professor Paul Workman). Phase I trials include first-in-human studies of novel anti-cancer agents. There are 20 – 30 phase 1 trials open at any given time, and Dr Banerji is a principal investigator on a number of them. Recent phase 1 trials include HSP90 inhibitors (17-DMAG; AUY922); PI3K inhibitors (PA799); MEK inhibitors (AZD6244; CKI-27) and HDAC inhibitors (CHR-3996; JNJ-586).
Dr Banerji is the Clinical Lead of the Good Clinical Practice Pharmacodynamic (GCP-PD) Group and works closely with Dr Michelle Garrett. This laboratory conducts pharmacodynamic assays on clinical samples taken during phase I trials and is crucial to defining proof-of-mechanism biomarker and PK-PD relationships. He also works closely with Dr Florence Raynaud in the Drug Metabolism and Pharmacokinetics (DMPK) Group on both pre-clinical and clinical PD models.
Biomarker Discovery and Application
Dr Banerji has an interest in the prognostic significance and the activation of the PI3K pathway in ovarian and lung cancer and its relationship to chemo-resistance. He is also interested in biomarkers of sensitivity to HDAC inhibitors. Other research interest include circulatory biomarkers of apoptosis following chemotherapy, and collaborations with the DMPK group to identify novel PD biomarkers to PI3K and RAS-RAF-MEK pathway inhibitors using metabonomics
Novel imaging is key to first-in-man phase I trials. Phase I first-in-man clinical trials routinely use FDG-PET imaging as a pharmacodynamic and prognostic tool. In addition, Dr Banerji has been involved in FLT-PET while studying targeted anti-folate agents and Zr-labelled bevacizumab or Zr-labelled trastuzumab PET scans to study pharmacodynamic markers of HSP90 inhibitors. He works closely with Professor Nandita de Souza and Dr Nina Tunariu on the role of diffusion-weighted (DW) and dynamic contrast-enhanced (DCE)-MRI to evaluate novel agents.
Clinical Applications and Targeted Agents
Dr Banerji is key to the development and execution of clinical strategies for drugs discovered by the Cancer Research UK Cancer Therapeutics Unit at the Institute of Cancer Research. He works closely with pre-clinical teams at the Cancer Therapeutics Unit at ICR, and the tumour units at the Royal Marsden Hospital to design these trials.