Advanced CancerPhase 1Amblyomin-XNCT03120130

Study of Amblyomin-X in Advanced Solid Tumor

A Phase 1 study testing Amblyomin-X in people with Advanced Cancer, run by União Química Farmacêutica Nacional S/A at 1 site in Brazil.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Cancer
What is being tested?: Amblyomin-X
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteBrazil
Study dates: 15 Feb 2021to 22 May 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

União Química Farmacêutica Nacional
São Paulo, São Paulo, 05676-120

Other trials in Brazil

About this study

Official title: 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

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.

Read the 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
Being tested: Amblyomin-X
Keywords: Phase I,

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Amblyomin-XBiological
Intravenous drug administration, with different doses in each cohort

Study groups in NCT03120130
Study group	Role	What they receive
Cohort 1	Experimental	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. Receives: Biological: Amblyomin-X
Cohort 2	Experimental	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 Receives: Biological: Amblyomin-X
Cohort 3	Experimental	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 Receives: Biological: Amblyomin-X
Cohort 4	Experimental	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 Receives: Biological: Amblyomin-X
Cohort 5	Experimental	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 Receives: Biological: Amblyomin-X
Cohort 6	Experimental	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. Receives: Biological: Amblyomin-X

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 2 weeks

Secondary outcomes (2)

maximum tolerated dose (MTD) and the recommended dose for phase II
This will be based on dose-limiting toxicity of the previous cohort
Measured: 2 weeks
Adverse Events
haematological toxicity
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202122 May 2022

First posted19 Apr 2017
Study start15 Feb 2021 (estimated)
Primary completion20 Aug 2021 (estimated)
Study completion22 May 2022 (estimated)

Why it stopped: Delay in the R \& D stage

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Study with dose escalation regime, done according to the classic scheme known as "3 + 3"
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03120130
Sponsor's protocol ID: PGUQ002
Acronym: Amblyomin-X
Status last verified: Jun 2019
First submitted: 29 Mar 2017
Last updated: 14 Oct 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03120130
Acronym / sponsor ID: Amblyomin-X / PGUQ002
Conditions: Advanced Cancer
Keywords: Phase I,
Phase: Phase 1
Study type: Interventional
Recruitment status: SuspendedReason stopped: Delay in the R \& D stage
Enrolment: 24 participants (estimated)
Lead sponsor: União Química Farmacêutica Nacional S/AIndustry (pharma, biotech, devices)
Collaborators: Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
Study start: 15 Feb 2021 (estimated)
Primary completion: 20 Aug 2021 (estimated)
Study completion: 22 May 2022 (estimated)
First posted: 19 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6
Model description: Study with dose escalation regime, done according to the classic scheme known as "3 + 3"

Arm	Type	Receives
Cohort 1	Experimental	Biological: Amblyomin-XThis 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.
Cohort 2	Experimental	Biological: Amblyomin-XThis 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
Cohort 3	Experimental	Biological: Amblyomin-XThis 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
Cohort 4	Experimental	Biological: Amblyomin-XThis 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
Cohort 5	Experimental	Biological: Amblyomin-XThis 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
Cohort 6	Experimental	Biological: Amblyomin-XThis 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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),

Key exclusion criteria (9 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amblyomin-XIntravenous drug administration, with different doses in each cohort	Biological	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6

Primary outcome

grade 4 or non-haematological grade 3 haematological toxicity according to the CTCAE (version 4)
Time frame: 2 weeks
Presence of grade 4 or non-haematological grade 3 haematological toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)

2 secondary outcomes

maximum tolerated dose (MTD) and the recommended dose for phase II
Time frame: 2 weeks
Adverse Events
Time frame: 4 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
Individual participant dataSharing planned: No

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Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paula F Santos study director

União Quimica

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Amblyomin-X in people with Advanced Cancer, run by União Química Farmacêutica Nacional S/A at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

grade 4 or non-haematological grade 3 haematological toxicity according to the CTCAE (version 4) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03120130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.