Intratumoral TriMix Injections in Early Breast Cancer Patients
Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
Patients with early breast cancer and accessible tumor lesions (1.00 to 10 ml volume) that
are eligible to either surgical removal of their tumor or neoadjuvant chemotherapy will be
injected with the IMP. Patients will be either treated with placebo (buffer alone, 12
patients) or with TriMix mRNA at three dose levels [8 at dose level I (1mg/ml), 8 at dose
level II (3mg/ml), and 8 at dose level III (6mg/ml). The volume injected in this group will
be adjusted to the tumour volume to ensure a perfusion of around 33% of the tumour volume
(33% +/- 5%). Therefore, depending on the patients' tumour size, 500, 1000 or 2000 µl of
TriMix mRNA solution or placebo solution will be injected into each tumor. Each patient will
receive three administrations of TriMix prior to start of general treatment (surgery or
neoadjuvant chemotherapy) separated by one week (7 days +/- 2 days) interval. The last
administration will be performed 2 days preoperatively or start of neoadjuvant chemotherapy.
The tumor and peripheral blood samples will be analyzed for immunological changes. If it is
decided by the multidisciplinary team that neoadjuvant therapy is more appropriate for the
patient, a second tumor biopsy (instead of surgical resection) will be taken 2 days after
third administration of TriMix mRNA to assess immunological changes within the tumor.
Similarly, patients that refuses to undergo surgery or to receive neoadjuvant chemotherapy
can be enrolled into the trial, if they accept three administrations of TriMix followed by a
second tumor biopsy.
The study will start with recruitment of the placebo group. The enrollment of the first three
patients in each cohort with Trimix mRNA will be staggered with at least one day between the
first dose of each individual patient. One week after the third patient of a cohort received
the third TriMix mRNA administration, an overall evaluation of the safety and tolerability of
this cohort will be done by the principal investigator. The results will be reviewed by an
in-house dose evaluation committee overseeing the safety and tolerability of TriMix mRNA.