עב  /  en

Choosing Hadassah

Phase 1

Phase 1/First in Human (FIH): HCRC Facility

  • Six patient rooms enable confinement of up to 15 subjects.
  • Eight out of the 15 beds are equipped with ICU level monitoring capabilities.
  • Equipment for emergency situations including well equipped Crash Cart.
  • Biological hood class B enabling the in-house preparation of investigational products prior to administration.
  • Controlled temperature refrigerators (2-8oC), freezers (-20oC and -80oC) and storage cabinets.
  • The handling of samples is performed in the laboratory which is located on the premises of the HCRC with the minimal needle-to-freezer time possible.

 

 

HCRC Staff

  • Founder and director of the HCRC is Prof. Yoseph Caraco, M.D., clinical pharmacologist. Prof. Caraco is a member of the local IRB committee and has served as the vice-chairperson of the committee since 2012.
  • 2 Research physicians
  • 2 Study nurses
  • 5 Study coordinators
  • 1 Dedicated physiotherapist
  • 1 Dedicated pharmacist
  • Experience in conducting clinical trials with special emphasis on early phases

 

 

Oncology Phase I unit

 

Dedicated Team:

  • Medical Manager
  • 3 experienced physicians
  • 1 senior study coordinator (superviser)
  • 2 study coordinators
  • 1 regulatory study coordinator
  • 1 administrative assistant

 

 

Capabilities:

  • ICU access
  • Overnight stay if needed
  • Experienced staff
  • Equipped local lab
  • Genetic testing
  • Oncogenetic cooperation
  • Molecular research assemblies
  • Radio-protected facility

 

 

Facilities:

  • Centrifuge (frozen and ambient)
  • Refrigerator (-200C and -800C)
  • Crash cart at the day care unit
  • ECG
  • IVAC
  • BP monitors
  • Oxygen access

 

 

FIH Experience

 

Investigator initiated studies:

  • Initial Assessment of the Effect of the Addition of Disulfiram (Antabuse) to Standard Chemotherapy in Lung Cancer
  • A phase 1/2 of a combination of Cetuximab and Taxane for “triple negative” breast cancer patients.

 

Sponsored studies:

  • A Phase 1, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64457107, an Agonistic Human Monoclonal Antibody Targeting CD40 in Patients with Advanced Stage Solid Tumors (17 patients were enrolled in 1.5 years)
  • A Phase 1a/1b Trial Investigating the CSF-1R Inhibitor LY3022855 in Combination with Durvalumab (MEDI4736) or Tremelimumab in Patients with Advanced Solid Tumors (3 patients were enrolled in 6 months)
  • A Phase 1b Study of Intratumoral IMO-2125 in Patients with Refractory Solid Tumors (Illuminate-101)
  • An exploratory, open label study to improve the function and welfare of late-stage solid cancer subjects (with or without lung involvement) by Amorphous Calcium Carbonate (ACC) treatment, administered orally and concomitantly with inhalation

 

 

 

Hematology Phase I unit

 

Indications:

  • Multiple myeloma, Amyloidosis
  • CLL, ALL, AML, MDS
  • Lymphomas- Hodgkin Lymphoma, Non-Hodgkin’s Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma
  • Myeloproliferative Diseases- CML, Polycythhemia vera, Myelofibrosis, Thrombocytopenia

 

 

Dedicated Team:

  • Medical Manager
  • 4 experienced senior hematologists.
  • 2 senior study coordinators (1 senior SC with 12 years’ experience)
  • Data entry Study Coordinator (CRF completion within 24-48 h)
  • 1 regulatory and administrative SC
  • 2 clinical trials nurses

 

 

Capabilities:

  • Clinical Trials extensive experience since year 2000
  • ICU access
  • Overnight stay if needed
  • Equipped local lab
  • Day-care Unit adjacent to the Hematology Clinical trials Unit
  • In-patient facilities adjacent to the Hematology Clinical trials Unit
  • Access to Molecular Laboratory
  • Access to FACS Laboratory
  • IATA certificates for Transporting Dangerous Goods
  • PK 24hs

 

Facilities:

  • Dedicated laboratory rooms
  • Centrifuge (frozen and ambient) (calibrated once a year)
  • Refrigerator (-200 C and -800 C) including monitoring system (& emergency SMS warning system) (calibrated once a year).
  • Crash cart
  • ECG
  • IVAC
  • BP monitors
  • Oxygen access

 

 

FIH Experience

 

Sponsored studies:

  • A phase Ib, open-label, multi-center, two-arm, dose-finding study to assess the safety and efficacy of the oral combination of Ruxolitinib (INC424) and BKM120 in patients with primary myelofibrosis (PMF), postpolycythemia vera-myelofibrosis (PPV-MF), or postessential thrombocythemia-myelofibrosis (PET-MF), (7 patients were recruited between 2012-2017).
  • A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64052781, a Humanized CD19 x CD3 Dual-Affinity Re-Targeting (DART®) Protein in Subjects with Relapsed or Refractory B-cell Malignancies (2 patients were recruited between 2016-2017).
  • A phase I dose-escalation study to assess the safety of AFM11 (CD19 x CD3 TandAb®) in patients with relapsed or refractory adult B-precursor acute lymphoblastic leukemia (Affimed), (1 patient was recruited between 2016-2018).
Skip to content