Clinical trials are an essential step in bringing innovative drug candidates to the patient. They aim to assess the safety and efficacy of a new drug and are performed under the strict guidance and control of regulatory agencies such as the Food and Drug Administration (FDA) in the US or the European Medicines Agency (EMA) in Europe.
Phase I clinical trials are first-in-human administration of a drug candidate. For life threatening diseases like cancer, they are often performed on a small number of volunteer patients with the aim of making sure that a new drug is well tolerated; determining if the drug can reach the diseased tissue and remains there long enough to provide benefit; and obtaining preliminary evidence of therapeutic activity.
Phase II clinical trials are performed only if phase I studies show no major safety issues. They involve a larger group of patients receiving different doses of a drug candidate in order to show its effectiveness in treating a disease; determine the optimal dose for therapeutic efficacy; and monitor for potential safety issues.
Phase III clinical trials are initiated only when the outcome of phase II studies are promising. They are normally conducted in a large number of patients in multiple countries and are designed to demonstrate safety and therapeutic benefit; confirm dosage; compare efficacy against existing drugs; and identify and characterise potential side effects. If the outcome of phase III studies is positive, then a new drug is submitted for approval to regulatory authorities in various countries so that the drug can become accessible to all patients who can benefit from treatment.
Completed Clinical Trials
Ganymed has sponsored several clinical trials to assess the safety and efficacy of IMAB362 and IMAB027. To obtain more information about these trials, please visit www.clinicaltrials.gov and search for “Ganymed”. Trials that are currently recruiting patients include:
Phase IIb (FAST) study to assess the efficacy and safety of IMAB362 in combination with chemotherapy agents in patients with advanced gastrointestinal adenocarcinomas (ClinicalTrials.gov Identifier: NCT01630083).
Phase I (PILOT) study to explore the safety and efficacy of IMAB362 in combination with immunomodulation agents in patients with advanced gastrointestinal adenocarcinomas (ClinicalTrials.gov Identifier: NCT01671774).
Phase I/II (OVAR) study to assess the efficacy and safety of IMAB027 as single agent in patients with advanced ovarian cancer (ClinicalTrials.gov Identifier: NCT02054351).
Phase IIa (MONO) study to assess the efficacy and safety of multiple doses of IMAB362 in patients with advanced gastroesophageal cancer (ClinicalTrials.gov Identifier: NCT01197885).
Phase I study to assess the safety and tolerability of IMAB362 in patients with advanced gastroesophageal cancer (ClinicalTrials.gov Identifier: NCT00909025).