NCT03120130

Study of Amblyomin-X in Advanced Solid Tumor

Phase I Study (First in Humans) of the Amblyomin-X in the Treatment of Patients With Advanced Solid Tumors Refractory or Without Indication / Access to Standard Treatment

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: União Química Farmacêutica Nacional S/A · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Amblyomin-X	Intravenous drug administration, with different doses in each cohort

Timeline

• Start date: 2021-02-15
• Primary completion: 2021-08-20
• Completion: 2022-05-22
• First posted: 2017-04-19
• Last updated: 2019-10-14

Locations

1 site across 1 country: Brazil