Amblyomin-X is an inhibitor of Factor Xa that also acts as an apoptotic agent for tumor cells. In the case of in vitro assays, Amblyomin-X induces tumor cells to death and does not affect the viability of normal cells. When in vivo assays were performed on mice bearing tumors, treatment with Amblyomin-X caused a significant reduction in tumor mass and number of metastases.
This trial will be the first clinical study in humans with the product, which until then has been studied only in experimental models. Given the current epidemiological impact of cancer and the need to improve its systemic treatment, making it available to a larger portion of the Brazilian population, it is proposed to conduct the first Amblyomin-X study in cancer patients, more specifically those with advanced solid tumors For which there is no contraindicated or inaccessible therapeutic option established as the standard at the time of inclusion in the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Intravenous drug administration, with different doses in each cohort
União Química Farmacêutica Nacional
São Paulo, São Paulo, Brazil
grade 4 or non-haematological grade 3 haematological toxicity according to the CTCAE (version 4)
Presence of grade 4 or non-haematological grade 3 haematological toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)
Time frame: 2 weeks
maximum tolerated dose (MTD) and the recommended dose for phase II
This will be based on dose-limiting toxicity of the previous cohort
Time frame: 2 weeks
Adverse Events
haematological toxicity
Time frame: 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.