Clinical trial, phase II: Evaluation of TheraCIM hR3 MaB combined with chemo- and radio-therapy to treat patients with epithelial tumors in neck of the uterus, stage III.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000054

Enrollment

148

Registered

2010-12-27

Start date

2007-05-30

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial tumors in neck of the uterus, stage III.

Interventions

Study group: A total of 200mg of TheraCIM hR3 MAb will be administered 9 times, combined with chemo- and radiotherapy. Dose 1. Prior to chemo- and radio-therapy. Dose 2-7. Together with the administra

Antibodies, Monoclonal, Humanized

Radiotherapy

Drug Therapy

Brachytherapy

Antibodies, Monoclonal

Administration, Intravenous

AcM TheraCIM hR3

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Patients giving their consent in writing to participate in the trial. 2) Female patients with measurable lesions, defined as those that can be exactly measured in one dimension at least (greater diameter) and have a diameter equal to or higher than 20mm, using conventional techniques (abdominal CAT, X rays, US), or higher than or equal to 10mm, using spiral CAT or clinical tests. 3) Patients aged 18 to 70. 4) General condition under ECOG =2. 5) Patients whose organs and bone marrow are working normally, as defined by the following parameters: - Hemoglobin >= 10g/L - Leucocytes >= 4,000/mL- Absolute neutrophil count >= 1,500/mL – Platelet count >= 100,000/L – Total bilirubin: up to 1.5 times the normal value - Total proteins: Within normal limits - TGP and TGO <= 2.5 times the institutional higher normal value – Serum creatinine: Within normal limits, and glomerular filtering based on Cockcrof Formula – Creatinine clearing = (140-age) x weight (kg)/72 x serum creatinine. Following clinical criteria, glomerular filtering will be performed only on patients whose kidney function is thought to be affected. (Normal laboratory values will be in keeping with the technology and equipment available where tests are conducted). 6) Female patients will be included in the study.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding. 2. Patients on another onco-specific drug under research (except EPOCIM and/or LeukoCIM). 3. Patients with history of allergy to chemical and biological compounds similar to the monoclonal antibody under evaluation. 4. Patients with uncontrolled intercurrent diseases, including active infections, symptomatic congestive cardiac failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, and psychiatric diseases. 5. Presence of a second tumor, except patients who have been on appropriate treatment for skin (basal or scaly) carcinomas.

Design outcomes

Primary

Measure	Time frame
Survival, measuring time: 2 years.	—

Secondary

Measure	Time frame
Antitumoral response, progression time, safety, HAMA response, reduced associated symptoms, measuring time: 3 months.	—

Countries

Cuba

Contacts

Public ContactMayra Ramos Suzarte

Center of Molecular Immunology (CIM)

mayra@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026