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Phase Ib/II Study of the Tumour-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Paclitaxel in Patients With Advanced Solid Tumours

Phase 1/Phase 2
18 Years
Open (Enrolling)
Tumour, Breast Cancer

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Trial Information

Phase Ib/II Study of the Tumour-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Paclitaxel in Patients With Advanced Solid Tumours

Inclusion Criteria:

- For Phase I of the study:

- For patient of Phase I cohort 1 i.e. those patients receiving F16IL2 alone,
patients must not be amenable to therapy with paclitaxel/taxanes but must be
considered by the Principal Investigator to be suitable candidates for F16IL2
therapy alone.

- Histologically or cytologically confirmed solid cancer with/without evidence of
locally advanced or metastatic disease (Appendix B).

- For advanced solid cancer patients, patients may have received previous
chemotherapy or radiation therapy, but they must be amenable for paclitaxel
treatment according to the discretion of the principal investigator.

- For Phase II of the study:

- Histologically or cytologically confirmed breast cancer.

- Prior radiation therapy is allowed, if the irradiated area is not the only
source of measurable or assessable disease.

- Patients not suitable for trastuzumab therapy (i.e., no evidence of
HER2-overexpressing disease, or trastuzumab therapy exhausted in
HER2-overexpressing disease).

- For phase I and II of the study:

- Patients aged ≥18 years.

- Patients recruited to Phase I, cohort I must be considered not suitable to
Taxane therapy in the opinion of the Principal Investigator.

- Patients must have at least one unidimensionally measurable lesion by computed
tomography as defined by RECIST criteria (see Section APPENDIX A). This lesion
must not have been irradiated during previous treatments.

- All acute toxic effects (excluding alopecia) of any prior therapy (including
surgery, radiation therapy, chemotherapy) must have resolved to National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v3.0)
Grade ≤ 1.

- Sufficient hematologic, liver and renal function:

- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L,
haemoglobin (Hb) ≥ 9.5 g/dl.

- Alkaline phosphatase (AP), alanine aminotransferase (ALT) and or aspartate
aminotransferase ≥ 3 x upper limit of reference range (ULN), and total
bilirubin ≥ 2.0 mg/gL unless liver involvement by the tumor, in which case
the transaminase levels could be up to 5 x ULN.

- Creatinine ≥ 1.5 ULN or 24 h creatinine clearance ≤ 50 mL/min.

- Life expectancy of at least 12 weeks.

- Documented negative test for human immunodeficiency virus.

- Negative serum pregnancy test for females of childbearing potential within 14
days of starting treatment.

- If of childbearing potential, agreement to use adequate contraceptive methods
(e.g., oral contraceptives, condoms, or other adequate barrier controls,
intrauterine contraceptive devices, or sterilization) beginning at the screening
visit and continuing until 3 months following last treatment with study drug.

- Evidence of a personally signed and dated Ethics Committee-approved Informed
Consent form indicating that the patient (or legally acceptable representative)
has been informed of all pertinent aspects of the study.

- Willingness and ability to comply with the scheduled visits, treatment plan,
laboratory tests and other study procedures.

Exclusion Criteria:

- Presence of active infections (e.g. requiring antibiotic therapy) or other severe
concurrent disease, which, in the opinion of the investigator, would place the
patient at undue risk or interfere with the study.

- Presence of known brain metastases. However, presence of controlled brain metastases
(i.e., evaluated as SD of PR after radiotherapy) is allowed.

- Known to have a second uncontrolled cancer of other primary origin within the last 5

- Chronic active hepatitis or active autoimmune diseases.

- History within the last year of acute or subacute coronary syndromes including
myocardial infarction, unstable or severe stable angina pectoris.

- Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).

- Irreversible cardiac arrhythmias requiring permanent medication.

- LVEF ≤ 50% and/or abnormalities observed during baseline MUGA, ECHO or ECG

- Uncontrolled hypertension.

- Ischemic peripheral vascular disease (Grade IIb-IV).

- Severe rheumatoid arthritis.

- Severe diabetic retinopathy.

- Recovery from major trauma including surgery within 4 weeks of administration of
study treatment.

- Known history of allergy to IL-2, Taxanes, or other intravenously administered human

- Pregnancy or breast feeding. Female patient must agree to use effective
contraception, or be surgically sterile or postmenopausal. The definition of
effective contraception will be based on the judgment of the principal investigator
or a designated associate.

- Phase I: Chemotherapy (standard or experimental) or radiation therapy within 4 weeks
of the administration of study treatment for patients recruited to the phase I part
of the study.

- Phase II:

- Chemotherapy (standard or experimental) within 4 weeks of the administration of
study treatment .

- Radiation therapy within 6 weeks of the administration of study treatment.

- Treatment with an investigational study drug within six weeks before beginning
of treatment with F16-IL2.

- Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6
weeks before administration of study treatment.

- Growth factors or immunomodulatory agents within 7 days of the administration of
study treatment.

- Neuropathy > Grade 1.

- Patient requires or is taking corticosteroids or other immunosuppressant drugs on a
long-term basis. Limited use of corticosteroids to treat or prevent acute
hypersensitivity reactions is not considered an exclusion criterion.

- Any conditions that in the opinion of the investigator could hamper compliance with
the study protocol.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the maximum tolerated dose (MTD) and the recommended dose (RD) of F16IL2 when administered in combination with paclitaxel (Phase I).

Outcome Description:

Safety evaluations performed days 1 through 28, including AEs, SAEs and standard laboratory assessments graded according to the NCI-CTCAE, v3, will be used for determination of dose limiting toxicity (DLT).

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Filippo de Braud, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

European Institute of Oncology Milan (Italy)


Italy: National Institute of Health

Study ID:




Start Date:

June 2008

Completion Date:

May 2013

Related Keywords:

  • Tumour
  • Breast Cancer
  • Interleukin, IL2, F16, monoclonal, antibody, cytokine Paclitaxel, breast cancer,solid tumour
  • Phase I: Advanced solid tumour patients
  • Phase II: breast cancer patients amenable to taxane therapy
  • therapy
  • Breast Neoplasms