Clinical trial · Interventional
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
NCT03120130CI-TRIAL-00041113Amblyomin-XsuspendedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Delay in the R \& D stage
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amblyomin-X | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 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.
- interventionNames
- Biological: Amblyomin-X
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- 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
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.