Studie: Phase I-II study to investigate the effectiveness, safety, and immunogenecity of a monotherapy with intradermal IMA910 plus GM-CSF following pretreatment with low dose cyclo-phosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first-line treatment with oxaliplatin-based chemotherapy.

Investigational product: IMA910 peptid based vaccine

Indication: advanced colorectal cancer

Study design: open-label, multicenter

Important criteria:

Inclusion: HLA-A*02-positive, Histologically confirmed CRC with radiological evidence (CT/MRI),  12 week first-line chemotherapy with an oxaliplatin-based regimen according to an established standard protocol (e.g. FOLFOX or XELOX), Response (CR, PR) or stabilization (SD) following a 12 week first-line oxaliplatin-based standard chemotherapy, At least one measurable lesion, Karnofsky Performance Status ≥ 80%.

Exclusion: Progressive disease during or at the end of 12 week systemic first-line oxaliplatin-based standard chemotherapy, Response to 12 week first-line oxaliplatin-based standard chemotherapy resulting in resectable disease; curative treatment intended, Known secondary neoplasia within the last 5 years except basal cell carcinoma or curatively excised cervical carcinoma in situ, central nervous system (CNS) metastases,  Specific laboratory ranges, Major surgery ≤4 weeks before first vaccination, Concurrent severe or uncontrolled medical disease, participation in a clinical trial less than 60 days prior to entry into this study. 

Study physician at SanaFontis: PD. Dr. med. J. Drevs (PI)

Status: start 12/08

Further information:

Medical Information Service

Tel.:  +49 (0761) 888 59-58 74
Fax:  +49 (0761) 888 59-59 57

E-Mail: medinfo(at)sanafontis.com

Phase II clinical trial to evaluate the efficacy and safety in patients with advanced colorectal cancer.

Investigational product: Auron Misheil Therapie (AMT2003)

Indication: advanced colorectal cancer

Study design: prospective, open, multicenter

Important criteria:

Inclusion: At least one measurable lesion,  Life expectancy at least 3 months.

Exclusion: Known secondary neoplasia or central nervous system (CNS) metastases, acute or chronic leukemia, lymphoma or multiple myeloma, Body weight below 45 kg, Concurrent severe or uncontrolled medical disease,  abnormal glucose tolerance test /latent diabetes mellitus type I or II, Chemotherapy, radiotherapy or other clinical tirasl less than 4 weeks prior to entry, Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery). 

Study physician at SanaFontis: PD. Dr. med. J. Drevs (PI)

Status: ongoing

Further information:

Medical Information Service

Tel.:  +49 (0761) 888 59-58 74
Fax:  +49 (0761) 888 59-59 57

E-Mail: medinfo(at)sanafontis.com