Phase I Unit

1About Phase I Unit

The Phase I Unit was established at Masaryk Memorial Cancer Institute in 2012 and currently conducts Phase I clinical trials in solid tumor indications, including first-in-human trials.

The inpatient part of the Unit with 24/7 operation is located in the Clinic of Comprehensive Cancer Care and has 6 semi-intensive beds with telemetry.

The outpatient section is located in the Day Care Center and is equipped with 6 beds with telemetry.

Administrative facilities are provided by the Department of Clinical Trials.

Our Phase I Unit is capable of providing:

  • Dose Escalation clinical trials
  • Intensive sampling for pharmacokinetics, pharmacodynamics and other sampling and processing to a central laboratory
  • Intensive monitoring of patients (telemetry, ECG, monitoring of vital signs)
  • Active participation of investigators in safety and efficacy consultations
  • Immediate availability of emergency medical care
  • Source documentation management according to ALCOA principles and data entry into eCRF by qualified data managers
  • Backing of the largest Department of Clinical Trials in the Czech Republic (monitoring area, experienced study team)

Conducting clinical trials according to Good Clinical Practice (GCP) and local SOPs.

The Phase I Unit holds a certificate for first-in-human clinical trials issued in October 2022 by the Czech regulatory agency SUKL in accordance with the requirements of EU Regulation 536/2014.

The site is part of the Prime Site IQVIA network (2022) and a certified Novartis Translational Clinical Oncology Centre (2016).

Compliance with Good Clinical Practice has been verified by FDA inspections (2012) and SÚKL inspections (2020, 2021, 2022), as well as annual sponsor audits.


2Our team

Head of Phase I Trial Unit

Assoc.Prof. Radka Lordick Obermannová, MD, Ph.D.

is a Consultant Medical Oncologist at the Department of Comprehensive Cancer Care at Masaryk Memorial Cancer Institute. She specializes in treating patients with gastrointestinal cancers. She graduated from Masaryk University in Brno and completed her Medical Oncology training and PhD studies at the same university. Her scientific focus on GI cancer inspired her to pursue a research career, particularly her interest in optimizing multimodal gastric cancer treatment involving predictors of treatment response.

Dr. Lordick Obermannova served as the head physician of the GI inpatient ward, and since 2012, she has been the chief physician of a Phase I Unit. She is involved in drug development as a principal investigator and co-investigator of phase I-III clinical trials. Dr. Lordick Obermannova is a co-author of national guidelines on esophageal and gastric cancer, and she is also a co-author of ESMO esophageal cancer treatment guidelines.

Dr. Lordick Obermannova is an active member of the ESMO Gastrointestinal Non-Colorectal Faculty Group and co-Chair of the EORTC Individualized Therapy Task Force at the Gastrointestinal Tract Cancer Working Group. She is also a member of the International Gastric Cancer Association (IGCA) and the Czech Society for Oncology.


3Clinical Trials

Protocol  

Study Title

Study Status

BNT152-01C

Phase I, first-in-human, open-label, dose escalation trial to evaluate safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of BNT152+153 in patients with solid tumors

enrolling

SN201

A multicentric phase 1/2 trial to evaluate the safety and efficacy of SOT102 as monotherapy and in combination with standard of care treatment in patients with gastric and pancreatic adenocarcinoma

enrollment temporarily halted

TU31-KH1

A Phase I Trial of a new orally administered platinum complex TU31 in patients with solid tumors.

now enrolling

CDFF332A12101

A Phase I/Ib, open-label, multi-center study of DFF332 as a

single agent and in combination with Everolimus or IO agents in patients with advanced/relapsed ccRCC and other malignancies with HIF2α stabilizing mutations

enrollment closed

D9720C00001

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (PETRA)

now enrolling

SC103

A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

enrollment closed


4Site Metrics and QA/QC

Masaryk Memorial Cancer Institute (MMCI) is the largest oncology center in the Czech Republic and, since 2023, the only Czech holder of the Comprehensive Cancer Center accreditation from the Organization of European Cancer Institutes (OECI). We meet high standards in clinical research.
 
For conducting clinical trials, MMCI has established an internal quality system. This includes quarterly evaluated quality indicators (Duration of the start-up phase of clinical trials), controlled documentation, and a set of about 30 Standard Operating Procedures for clinical trials (SOP). Since 2004, MMCI has undergone over 30 audits and inspections (SÚKL, FDA) on clinical trials, with no critical findings identified. The latest SÚKL inspection took place in June 2023.
 
From a recruitment perspective, a priority for MMCI is to enroll a target number of patients. In many cases, MMCI is the top enrolling site with in the Czech Republic or even the broader region. Recruitment for clinical trials is mostly secured from site patient database as the largest specialized oncology center in the Czech Republic, but we also effectively collaborate with referring facilities within the regional oncology network. Key is the good awareness of physicians about open clinical trials - internally, we use the hospital information system, and externally, the website and recently, a periodically distributed newsletter.
 
Other priorities for MMCI in conducting clinical trials include:
  • Speed and quality of data entry into the eCRF - ensured by 6 data managers from the Clinical Trials Unit, with data entered within 2-5 days after a study visit or as per the sponsor's requirements
  • Speed of the start-up phase of clinical trials - ensured by the CTU start-up team. More information for study sponsors can be found here
  • Maintaining a drop-out rate of 0%

6Patient Referrals

If you are a physician interested in referring a cancer patient to a clinical trial, please contact us using the form or email [obfuscate_1_|114|107|109|93|104|100|55|101|104|116|45|90|114].

Phase I Referral Form

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