recurrent advanced ovarian cancer MedDRA version: 17.1 Level: LLT Classification code 10033130 Term: Ovarian cancer NOS System Organ Class: 100000004864 MedDRA version: 17.1 Level: LLT Classification code 10016183 Term: Fallopian tube cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Product Name: IMAB027
Product Code: IMAB027
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: IMAB207
Current Sponsor code: IMAB027
Concentration unit: mg mill
Sponsors
Ganymed Pharmaceuticals AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Signed written informed consent (2) Female patients =18 years of age, no upper age limit. (3) Histologically or cytologically confirmed CLDN6+ ovarian cancer of any histology type including primary peritoneal or fallopian tube tumors (histological documentation of the original primary tumor is required via a pathology report) that are either: Patients with symptomatic recurrence • Primary-refractory to platinum therapy (as evaluated after at least 2 cycles of platinum-containing therapy); OR • Platinum-resistant population: relapsed 12 weeks (8) Adequate organ function defined as: • Adequate hematologic function (ANC =1000/µl, platelets =100.000/µl, hemoglobin =8.5 g/dl [5.6 mmol/l] (can be post transfusion)) • Adequate renal function (serum creatinine =1.5 mg/dl [114.5 µmol/l] or creatinine clearance rate =30 ml/min) • Adequate liver function (serum total bilirubin =2 x ULN, AST/ALT =3 x ULN) (9) Patients of child-bearing potential must have a negative ß-HCG urine test within 72 hours before receiving treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 79 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: (1) Patient is pregnant or breast-feeding (2) Prior allergic reaction or intolerance to a monoclonal antibody (humanized or chimeric) (3) Any prior anti-tumor therapy within 14 days prior to the start of IMAB027 treatment (4) Other concurrent anticancer therapies (5) HIV infection in medical history or active, medicinally not well controlled Hepatitis B or C infection (6) History of any one or more of the following cardiovascular conditions within the past 6 months: • Myocardial infarction (T-Wave/Non-T-Wave) • Unstable angina pectoris • Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA) • History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT). Patients with recent DVT who have been or are treated with therapeutic anti-coagulant agents (excluding warfarin) for at least 6 weeks are eligible (7) Other investigational agents or devices concurrently or within 14 days before start of IMAB027 treatment. If half-life of prior investigational agent is >7 days, distance to prior investigational agent should be at least two half-lives. Patients with prior radiotherapy are allowed, if discontinued at least 14 days prior to the first dose of study medication. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy (8) Any hemoptysis or bleeding event that is clinically relevant within 2 weeks of first dose of study drug (9) Clinical symptoms of brain metastases or tumor-associated spinal cord compression. (10) Need for continuous, systemic immunosuppressive therapy. Concurrent systemic immunosuppressive therapy, in particular systemic corticoids must be stopped 2 weeks prior first treatment. Inhaled and topically applied steroids are allowed. Systemic steroids should be avoided as long as patient is under study medication. (11) Any other medical condition that would, in the opinion of the Investigator, limit the patient’s ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: Assess safety and tolerability Phase II: Assess antitumoral activity ;Secondary Objective: Phase I: Assess pharmacokinetics Assess antitumoral activity Assess immunogenicity Characterization of biomarkers Phase II: Assess safety and tolerability Determine pharmacokinetics Determine immunogenicity Characterization of biomarkers;Primary end point(s): Phase I: Safety profile including type, frequency, severity, relationship of adverse events to study treatment, dose limiting toxicities, maximum tolerated dose Phase II: Same as for Phase I and additionally disease control rate;Timepoint(s) of evaluation of this end point: Phase I: Safety will be assessed throughout the whole study. DLT/MTD will be assessed prior to inclusion of a new patient (stage I) and prior to next dose level or prior to each new dose level (stage II) Phase II: CTs or MRIs and tumor marker analysis will be performed every 6 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I: (1) Cmax, AUC, terminal half-life and related pharmacokinetic parameters (2) Frequency of anti-IMAB027 antibodies (3) Disease control rates (CR, PR, SD) (4) Ratio previous/current remission time intervals (5) Overall survival Phase II: (1) Safety profile including type, frequency, severity, relationship of adverse events to study treatment, dose limiting toxicities, maximum tolerated dose (2) Objective response rate (3) Ratio previous/current remission (4) Progression free survival (5) Overall survival (6) Duration of response (7) Cmax, AUC, terminal half-life and related pharmacokinetic parameters (8) Frequency of anti-IMAB027 antibodies;Timepoint(s) of evaluation of this end point: Phase I: PK, Biomarkers and ADAs will be analyzed at specific timepoints throughout the study. CTs/MRIs and tumor marker analysis will be performed every 6 weeks. | — |
Countries
Belgium, Bulgaria, Germany, Russian Federation, Ukraine
Contacts
Public ContactClinical Trial Information Desk
Ganymed Pharmaceuticals AG
Outcome results
None listed