Study of Amblyomin-X in Advanced Solid Tumor

NCT ID: NCT03120130

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2022-05-22

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

This cohort will include 3 patients with the first calculated dose of Amblyomin-X drug. The patient will receive the intravenous drug. If no Dose-limiting toxicity (DLT) in this group the study continues including the next cohort. However, if If only one patient in a given cohort develops DLT, three more patients will be included at that dose level, up to a maximum total of six patients per dose level. If two or more of the three patients of a certain dose level develop DLT, this dose level is considered very toxic, and the study does not proceed. If this occurs at the first dose level, the study will be finalized. If only one in six patients at a dose level develops DLTs, escalation proceeds until Tolerated Maximum Dose.

Group Type: EXPERIMENTAL

Amblyomin-X

Intervention Type: BIOLOGICAL

Intravenous drug administration, with different doses in each cohort

Cohort 2

This cohort will include 3 patients with the second calculated dose of Amblyomin-X drug. The patient will receive the intravenous drug. If no Dose-limiting toxicity in this group the study continues including the next cohort

Group Type: EXPERIMENTAL

Amblyomin-X

Intervention Type: BIOLOGICAL

Intravenous drug administration, with different doses in each cohort

Cohort 3

This cohort will include 3 patients with the third calculated dose of Amblyomin-X drug. The patient will receive the intravenous drug. If no Dose-limiting toxicity in this group the study continues including the next cohort

Group Type: EXPERIMENTAL

Amblyomin-X

Intervention Type: BIOLOGICAL

Intravenous drug administration, with different doses in each cohort

Cohort 4

This cohort will include 3 patients with the fourth calculated dose of Amblyomin-X drug. The patient will receive the intravenous drug. If no Dose-limiting toxicity in this group the study continues including the next cohort

Group Type: EXPERIMENTAL

Amblyomin-X

Intervention Type: BIOLOGICAL

Intravenous drug administration, with different doses in each cohort

Cohort 5

This cohort will include 3 patients with the fifth calculated dose of Amblyomin-X drug. The patient will receive the intravenous drug. If no Dose-limiting toxicity in this group the study continues including the next cohort

Group Type: EXPERIMENTAL

Amblyomin-X

Intervention Type: BIOLOGICAL

Intravenous drug administration, with different doses in each cohort

Cohort 6

This cohort will include 3 patients with the sixth calculated dose of Amblyomin-X drug, the last dose calculated. The patient will receive the intravenous drug.

Group Type: EXPERIMENTAL

Amblyomin-X

Intervention Type: BIOLOGICAL

Intravenous drug administration, with different doses in each cohort

Interventions

Amblyomin-X

Intravenous drug administration, with different doses in each cohort

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Eligible patients must sign the Free and Informed Consent Term (TCLE),
• be between 18 and 75 years of age,
• present a solid tumor proven by anatomopathological examination at an advanced or metastatic stage and refractory to conventional treatment or without current indication or access to conventional treatment ,
• have a life expectancy of at least 12 weeks.
• presence of measurable disease according to Response Response Criteria in Solid Tumors (RECIST, version 1.1),
• medullary, renal and hepatic functions within acceptable limits (defined in protocol),
• end of the previous antineoplastic treatment at least 4 weeks (since the last dose of any antineoplastic medication, radiotherapy, or surgical procedure).

Exclusion Criteria

• The presence of previously non-irradiated brain metastasis;
• Prediction of the use of radiotherapy, surgery, systemic antineoplastic treatment, or any other form of treatment for cancer after inclusion in the study;
• Prediction of corticosteroid use, hematopoietic growth factors or inhibitors of bone resorption during the first course of treatment (4 weeks);
• Regular use of anticoagulants or known previous coagulation disorder;
• Severe comorbidity (at the discretion of the researcher);
• Gestational, lactating, pregnant women, or who have not been surgically infertile or menopausal for at least 12 months;
• Men and women who refuse to use an adequate contraceptive method during the study period;
• Participation of another clinical study in the last 12 months (unless justified by the investigator);
• Or inability to comply with study requirements and procedures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME

INDUSTRY

Sponsor Role: collaborator

União Química Farmacêutica Nacional S/A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paula F Santos

Role: STUDY_DIRECTOR

União Quimica

Locations

União Química Farmacêutica Nacional

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

PGUQ002

Identifier Type: -

Identifier Source: org_study_id