IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC)

Inclusion Criteria:

* Patient with metastatic renal clear cell (MRCC) adenocarcinoma, histologically proven by biopsy of the primary tumor and/or a metastasis. Prior nephrectomy is not required. The patient will be included in the study only if an efficacious cancer treatment can not be proposed.
* Patient to whom the currently available anticancer treatments are contra-indicated.
* Male or female 18 years or above. NB: Women must be either post-menopausal, rendered surgically sterile or practicing a reliable method of contraception (hormonal, intrauterine device or barrier). Pregnant women are excluded from this study.
* ECOG performance status 0-1.
* Expected survival longer than three months.
* Total white cell count ≥ 3.109/L.
* Platelet count ≥ 100.109/L.
* Hemoglobin \> 9 g/dL or \> 5.58 mmol/L.
* Serum creatinine \< 160 µmol/L.
* Total bilirubin \< 20 mmol/L, except for familial cholemia (Gilbert's disease)
* Serum ASAT and ALAT \< 3 times the upper limit of normal or \< 5 times upper limit of normal if liver metastases are present.
* Able to give written informed consent and to comply with the protocol.

Exclusion Criteria:

* Pregnancy, lactation or lack of effective contraception in fertile women of childbearing potential.
* Serious intercurrent infection within the 30 days prior to first administration.
* Known clinically active autoimmune disease.
* Known B or C active hepatitis.
* Known HIV positivity.
* Life threatening illness unrelated to cancer.
* Known cerebral metastases.
* Previous malignancies within the last two years other than successfully treated squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy.
* Previous history of major psychiatric disorder requiring hospitalization or any current psychiatric disorder that would impede the patient's ability to provide informed consent or to comply with the protocol.
* Corticosteroids unless used as substitutive therapy.
* Past history of severe allergic episodes and/or Quincke edema.
* Past or present history of any organic disorder likely to modify absorption, distribution or elimination of the study drug.
* Alcohol or substance abuse disorder.
* IL-2 therapy or any other investigational agent within 30 days of first administration.
* Chemotherapy or radiotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to first administration of the study drug or lack of recovery from adverse events (to grade 1 or less toxicity according to CTCAE 3.0) due to agents administered more than 4 weeks earlier. Exception is made regarding the x-ray treatment for painful bone metastases.