Exploratory, open and multicenter study of the use of the humanized monoclonal antibody itolizumab (antiCD6) in patients with solid tumors.

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Secondary indentifying numbers:

FL-EC-0029

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center for Molecular Immunology (CIM); Cuban Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Raiza

Midle name:

Ruiz

Last name:

Lorente

Medical Specialty :

Second degree specialist in Oncology

Affiliation:

“Ramon Gonzalez Coro” Gynecobstetric Teaching Hospital

Postal address:

Calle 21 No. 856 e/ 4 y 6, Vedado, Plaza de la Revolucion.

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78382622

Email address:

raizaruiz@infomed.sld.cu

raiza2661@gmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, “Comandante Manuel Fajardo” Clinical Surgical University Hospital, Olivia Blanco Pita.MD, First Degree Specialist in Oncology

Havana, "Miguel Enriquez” Clinical Surgical Teaching Hospital, Noralys Lara Fernandez.MD , First Degree Specialist in Oncology

Havana, "Joaquin Albarran Dominguez" Clinical Surgical Teaching Hospital, Eva Elena Solomon.MD. First Degree Specialist in Oncology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

07/11/2022

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Solid tumors CD 318+, Breast cancer, Colon cancer, Ovarian cancer

Intervention(s):

Group A (Experimental): Itolizumab in two stages, Induction (stage I) and Maintenance (stage II). In stage I, the patient will receive a dosage of 100 mg, by endovenous route, every 7 days duringfor 8 weeks with a total of 9 doses. After 21 days of stage I completed, the patient will begin the stage II. In this stage the patient will receive 100 mg, by endovenous route, every 21 days until complete 6 administrations. Group B (Experimental): Itolizumab in two stages, Induction (stage I) and Maintenance (stage II). In stage I, the patient will receive a dosage of 200 mg, by endovenous route, every 14 days for 8 weeks with a total of 5 doses. After 21 days of stage I completed, the patient will begin the stage II. In this stage the patient will receive 100 mg,by endovenous route, every 21 days until complete 6 administrations.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. Serious adverse event of intensity grade 3/4 that threatens/incapacitates or that produces death (From the total number of patients who will receive treatment, the percentage that developed serious AEs will be calculated, according to the (CTCAE v5) classification). Measurement time: During the treatment until month 12. 2.Objective response rate (Complete Response o Partial Response according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). It will be classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)). Measurement time: Week 30.

Key secondary outcomes:

1. Overall Survival (Time elapsed from randomization until the patient's death will be measured, regardless of the cause or until the date of the latest news by clinical history). Measurement time: 12 months. 2. Immunological evaluation (The expansion of the populations of effector T lymphocytes, natural killer cells (NK) and Treg lymphocytes will be evaluated. In these populations, the memory subpopulations and the activation parameters will also be estimated. The ROC curves will be evaluated to study possible predictive thresholds of OR, SV and PFS. Thresholds will be evaluated as those that maximize the Sensitivity (probability of detecting a positive result if the objective response is positive) and Specificity (probability of detecting a negative result if there is no objective response) of the Area under the ROC curve. If such thresholds are obtained, the immunological variables will be categorized and the positive predictive values (VP+), the negative predictive values (VP-) and the % of classifications will be estimated, correctly evaluated with their respective 95% confidence intervals). Measurement time: Day 0 and weeks 8,11,26,30 and 48. 3. Response duration (Time, in days, elapsed from the date the patient achieves a response with study treatment (CR/PR) to objective disease progression or death). Measurement time: 12 months

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

1. Patients who meet the diagnostic criteria. 2. Patients who give their informed consent for participation in writing. 3. Patients of either sex aged over 18 years. 4. Patients with general condition ≤ 2 (according to ECOG) 5. Patients with life expectancy of at least 3 months. 6. Patients who do not agree to receive another available cancer treatment option. 7. Patients with organ and bone marrow function defined by the following parameters: Hemoglobin ≥ 10 g/dl,total Leukocyte Count ≥ 3 x 109/L,Platelet count ≥ 100 x 109/L, total bilirubin: within normal limits for the institution, TGP and TGO ≤2.5 times the institutional upper normal limit, creatinine:within normal limits for the institution.

Exclusion criteria:

1. Patients of childbearing age who are not using an adequate method of contraception prior to inclusion in the study (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). In the case of the male sex (vasectomy, use of condoms). 2. Pregnant or lactating patients. 3. Patients with acute allergic states or a history of severe allergic reactions. 4. Patients with acute or chronic decompensated lung diseases that may interfere with the monitoring of the underlying disease. 5. Patients with intercurrent uncontrolled diseases that include, but are not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus and psychiatric diseases that imply incompetence of the subject. 6. Patients who are receiving another investigational product or have recently finished the use of any monoclonal antibody. 7. Patients with known hypersensitivity to any component of the formulation. 8. Patients with known positive serology for HIV, hepatitis B or C.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized trial

Masking:

Open

Control group:

Dose comparison

Study design:

Parallel

Phase:

0

Target sample size:

40

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Mayra

Last Name:

Ramos Suzarte

Specialty:

Biochemistry. PhD

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 street corner 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72143146

Email :

mayra@cim.sld.cu

ramossuzartem@gmail.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mayra

Last Name:

Ramos Suzarte

Specialty:

Biochemistry. PhD

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 street corner 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72143146

Email :

mayra@cim.sld.cu

ramossuzartem@gmail.com

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

“Ramon Gonzalez Coro” Gynecobstetric Teaching Hospital

“Comandante Manuel Fajardo” Clinical Surgical University Hospital

“Miguel Enriquez” Clinical Surgical Teaching Hospital

"Joaquin Albarran Dominguez" Clinical Surgical Teaching Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

01/09/2022

29/09/2022

21/09/2022

20/09/2022

Postal address of Ethic Committee :

21 e/ 4 y 6, Plaza de la Revolucion, ZC: 10400, Havana. Cuba

Calle D entre 29 y Zapata, Vedado, Plaza de la Revolucion, Havana. Cuba

Ramon Pinto 202 e/ Concha y Arango. Luyano, Diez de Octubre, ZC:10700, Havana. Cuba

Av.26 e/ Av. Independencia, Puentes Grandes, Plaza de la Revolucion, Havana. Cuba

Telephone:

+53-52930683

+53-78325238

+53-53587877

+53-76424516

Email:

miguel.sarduy@infomed.sld.cu

-

drrjesusvc@gmail.com

yea@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

40

Study completion date:

03/10/2024

Date of available results:

31/12/2024

Date of first publication:

15/12/2025

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000444

Date of Registration in Primary Registry:

18/06/2024

Record Verification Date:

2024/06/18

Next update date:

2025/06/18

Link to the spanish version:

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Exploratory, open and multicenter study of the use of the humanized monoclonal antibody itolizumab (antiCD6) in patients with solid tumors.

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