Description:
The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses of 30 µg, 100 µg or 300 µg IM every three weeks.
The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses of 30 µg, 100 µg or 300 µg IM every three weeks.
Active, not recruiting
Phase 1
Drug | Synonyms | Arms |
---|---|---|
MAG-TN3 + AS15 | MAG-Tn3 + AS15 |
This study is a three dose level open-label, non-randomized, dose-escalation study Phase I of the safety of the vaccine candidate MAG-Tn3 + AS15 administered to patients with HER2 negative, high-risk localized breast cancer in remission. A maximum of 30 patients will be included in the study: - 3 or 6 patients in the 1st dose level (30 µg) - 6 or 12 patients in the 2nd dose level (100 µg) - 6 or 12 patients in the 3rd dose level (300 µg) The clinical study phase I is composed of a vaccination period of about 4 months (16 weeks) and a follow-up period of 36 months (3 years). Each patient will receive one of the three escalating doses of MAG-Tn3 in combination with a fixed dose of AS15 adjuvant. The subject will receive 6 vaccine injections, administered by intramuscular injection with a 3-weeks interval between injections. Each patient will be followed 36 months after the last injection. The follow-up period is composed of a short-term follow-up period of 6 months and a long-term follow-up period of 30 months. A total of 20 visits will be required for each patient. Clinical data and blood samples will be collected for analysis for each patient. Clinical study data will be recorded for each patient on source documentation and then entered on electronic CRFs (eCRFs) using a proprietary Electronic Data Capture (EDC) Clinical Data Base Software System. The eCRF data are to be entered by site personnel trained in EDC data entry. A monitor will visit the site regularly to check the completeness of patient records, the accuracy of entries on the e-CRFs, the adherence to the protocol and to Good Clinical Practice, the progress of enrollment, and to ensure that study drug is being stored, dispensed, and accounted for according to specifications. Institut Pasteur or designated CRO will conduct data management. Data entered into EDC will be housed in a central database. Changes will be tracked to provide an audit trail. Interactive data checks will be carried out as applicable during the data entry process. Additional data checks are programmed to identify errors in the SAS datasets. Applicable queries based on the SAS datasets will be added to EDC for resolution by data management personnel. At the conclusion of the study, when all data have been entered and source document verified, with no outstanding queries remaining, the Investigator of each site will be required to electronically sign each patient's casebook to confirm that the data for each patient are complete and accurate and consistent with the patient's source documents. The data will then be locked to prevent further editing. Concomitant medications entered into the database will be coded using the WHO Drug Reference List, which employs the Anatomical Therapeutic Chemical classification system. Medical history/current medical conditions and adverse events terminology will be coded using the Medical dictionary for regulatory activities.The newest version of the dictionary at data base lock will be used.
Name | Type | Description | Interventions |
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MAG-Tn3 + AS15 | Experimental | 3 escalating doses of MAG-Tn3 in combination with a fixed dose of AS15 adjuvant. For each dose patient will receive 6 injections at 3 interval weeks. |
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Inclusion Criteria: 1. All patients must have a diagnosis of epithelial breast carcinoma which is, according to TNM classification: - Any T - With Positive (N+) or Negative (N-) Lymph-Node depending on the patient profile - And Non metastatic (M0) 2. HER2/neu-negative (Immunohistochemical expression "0-1+", and/or FISH/CISH "non amplified" according to ASCO 2012 criteria) 3. First line treatment population with a High-Risk of Relapse as defined by: - with at least 4 positive lymph nodes (LN) at primary surgery, or at least one positive lymph node >pN1mi after completion of 6-8 cycles of anthracyclines/taxanes-based neoadjuvant chemotherapy - Or, negative hormone receptors: ER- and PR- , (<10%), i.e "Triple Negative breast cancer" With at least one positive lymph node >pN1mi or negative lymph node if a pathological complete remission was not achieved (persistence of invasive carcinoma) after completion of 6-8 cycles of anthracyclines/taxanes-based neoadjuvant chemotherapy 4. Patients must have completed all their local and regional treatments including adequate surgery and radiation therapy, and at least 6 cycles of chemotherapy (neoadjuvant and/or adjuvant) according to institutional and national standards. 5. The time interval between the end of all the first line standard treatment (completion of surgery, chemotherapy and radiation therapy) should be at least 3 months and within a maximum of 18 months before inclusion in the study. Exclusion Criteria: 1. Any breast cancer recurrence or metastasis. 2. Patients with HER2/neu positive breast carcinoma (IHC score 2+ or 3+ and/or FISH/CISH-amplified). 3. Patients with any uncontrolled bleeding disorder including coagulation disorder or thrombocytopenia or prothrombotic disorder. 4. Patients with a personal history of autoimmune disease (including but not limited to multiple sclerosis, lupus, rheumatoid polyarthritis, inflammatory bowel diseases, Graves' disease and Hashimoto's disease). 5. Patients with a history of previous anaphylaxis or severe allergic reaction to vaccines or other known or unknown allergens. 6. Patients who have received any commercial vaccine within one month before the first dose of study vaccine or are planned to receive any vaccine till 3 weeks after the 6th vaccine injection.
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 40 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | To assess the number of patient(s) presenting dose-limiting toxicities (DLTs) from the first vaccine injection in the first patient of the dose cohort till 3 weeks after the second vaccine injection of the last patient of the dose cohort. |
Time Frame: | 3 weeks after 2 study vaccine injections corresponding to visit number 5. |
Safety Issue: | |
Description: |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Institut Pasteur |