PankoMab-GEX™: Dose Escalation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01222624
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : May 16, 2013
Information provided by (Responsible Party):
Glycotope GmbH

Brief Summary:
This is a prospective, open label, dose escalating, multicenter, phase I study measuring the safety, tolerability, and pharmakokinetics of PankoMab-GEX™ after intravenous administration in patients with locally advanced or metastatic solid cancers refractory to standard treatment. The effect of PankoMab-GEX™ on the development of antibodies and tumor response will also be evaluated.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: PankoMab-GEX™ Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation Study Evaluating the Safety and Tolerability of PankoMab-GEX™ in Patients With Advanced, TA-MUC1 Positive Solid Malignancies Who Are Not Longer Eligible for Standard Therapy
Study Start Date : November 2009
Primary Completion Date : December 2012
Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: PankoMab-GEX™, 3-weekly
application, q3w
Drug: PankoMab-GEX™
Experimental: Experimental: PankoMab-GEX™, 2-weekly
application q2w
Drug: PankoMab-GEX™
Experimental: PankoMab-GEX™, weekly
application q1w
Drug: PankoMab-GEX™

Primary Outcome Measures :
  1. To evaluate the safety and tolerability profile of PankoMab-GEX™ at various dose levels [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  1. To evaluate any immunogenicity [ Time Frame: throughout study ]
  2. To evaluate any objective tumor response (according to RECIST Criteria) [ Time Frame: after every second therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female and age ≥ 18 yrs
  2. Histologically-confirmed TA-MUC1 positive measurable or non-measurable solid tumors according to RECIST criteria who failed standard therapy and for whom no further standard therapy is available (TA-MUC1 positivity assessed by PankoMab-GEX™ staining in immunohistology of the tumor).
  3. Failure of standard therapy or non-availabilty of standard therapy

    • Patients must have received at least 1 standard chemotherapy during the course of the tumor disease
    • All therapies must be completed 6 weeks (therapeutic monoclonal antibodies) or 4 weeks (all other anti-cancer agents) before start of study treatment and patients must have recovered from all prior therapy toxicities to at least CTCAE grade 1
  4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1 and estimated life expectancy of > 3 months
  5. Adequate organ function as assessed by the following laboratory parameters within 14 days prior to study drug application:

    • Bone marrow function: hemoglobin ≥ 100 g/L; white blood cell count (WBC) ≥ 3.0 x 10^9/L; absolute neutrophil count (ANC) ≥ 1.5x 10^9/L; platelet count ≥ 100 x 10^9/L
    • Hepatic: aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤ 2.5 times upper limit of normal (ULN) (≤ 5 x ULN if hepatic metastases present); bilirubin ≤ 1.5 x ULN; alkaline phosphatase ≤ 5.0 times upper limit of normal (ULN)
    • Renal: Calculated creatinine clearance > 80 ml/min using the MDRD formula according to Levey 2005: Glomerular filtration rate (GFR) (ml/min/1.73 m²) = 186 x (serum creatinine /0,95)^-1.154 x (age)^-0.203 x (0.742 females) x (1.21 in black patients)
  6. Patients of both genders with procreative potential must use effective contraception while enrolled in the study and for at least 6 weeks after the last study drug infusion
  7. Written informed consent must be obtained prior to conducting any study-specific procedures

Exclusion Criteria:

  1. Antibody-based immunotherapy within 6 weeks and chemotherapy, radiation or other anti-cancer therapies within 4 weeks prior to study enrolment
  2. Any investigational agents at the study enrolment
  3. Concurrent anti-tumor therapy or concurrent immunotherapy
  4. Concurrent systemic steroids except topical (inhaled, topical, nasal), replacement therapy for the last 28 days. Steroids at low and stable dose (up to 20 mg prednisone) given for chronic disease are also permitted
  5. History of allergic reactions to previous antibody therapy
  6. Major surgery within 4 weeks prior entering the study and/or incomplete recovery from surgery or planned major surgery
  7. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy such as sarcoidosis, lupus erythematosus, rheumatoid arthritis, glomerulonephritis or systemic vasculitis (except autoimmune thyroiditis with only thyroid hormone replacement and stable disease > 1 year)
  8. Primary or secondary immune deficiency
  9. Clinically active infections > CTCAE grade 2
  10. Prior allergic reaction to a monoclonal antibody (e.g. Trastuzumab, Cetuximab or Bevazizumab).
  11. Active hepatitis B or C; human immunodeficiency virus (HIV) seropositivity
  12. Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥ 3 years will be allowed to enter the study.
  13. Uncontrolled medical condition considered as high risk for the treatment with an investigational drug including unstable diabetes mellitus, vena-cava-syndrome, chronic symptomatic respiratory disease.
  14. Brain metastasis or leptomeningeal involvement
  15. Symptomatic congestive heart failure (New York Heart Association [NYHA] 3 or 4); unstable angina pectoris within 6 months prior to enrollment; significant cardiac arrhythmia, history of stroke or transient ischemic attack within 1 year or left ventricular ejection fraction (LVEF) below the institutional range of normal on a baseline multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
  16. History of seizures, encephalitis or multiple sclerosis
  17. History of deep vein thrombosis and/or thromboembolic events within the past 6 months before entering the study and/or requiring anticoagulation therapy
  18. Evidence or history of bleeding diathesis or coagulopathy
  19. Active drug abuse or chronic alcoholism
  20. Pregnancy or Breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01222624

Glycotope Investigational Site
Hamburg, Germany, D-20246
Glycotope Investigational Site
Milan, Italy, 20132
Glycotope Investigational Site
Milan, Italy, 20133
Glycotope Investigational Site
Bellinzona, Switzerland, CH-6500
Sponsors and Collaborators
Glycotope GmbH
Study Director: Glycotope GmbH Glycotope GmbH

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Glycotope GmbH Identifier: NCT01222624     History of Changes
Other Study ID Numbers: GEXMab25101
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013

Keywords provided by Glycotope GmbH:
advanced solid malignancies