Know Cancer

forgot password

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

Phase 1
18 Years
Not Enrolling
Solid Tumors

Thank you

Trial Information

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

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

- 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

- 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

7. Written informed consent must be obtained prior to conducting any study-specific

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability profile of PankoMab-GEX™ at various dose levels

Outcome Time Frame:

throughout the study

Safety Issue:


Principal Investigator

Glycotope GmbH

Investigator Role:

Study Director

Investigator Affiliation:

Glycotope GmbH


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

November 2009

Completion Date:

May 2013

Related Keywords:

  • Solid Tumors
  • advanced solid malignancies