Use of h-R3 monoclonal antibody and radiotherapy to treat patients with advanced epithelial head and neck tumors.

Phase Ib/IIa clinical trial: Use of h-R3 monoclonal antibody and radiotherapy to treat patients with advanced epithelial head and neck tumors.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000071

Enrollment

Registered

2010-12-17

Start date

1999-08-09

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

Advanced epithelial head and neck tumors.

Interventions

Four levels of MAb hR3 doses Level 1: 50 mg once a week, for 6 weeks (Total doses: 300 mg) Level 2: 100 mg once a week, for 6 weeks (Total doses: 600 mg) Level 3: 200 mg once a week, for 6 weeks (

Antibodies, Monoclonal, Humanized

Radiotherapy

Antibodies, Monoclonal

AcMh-R3

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients with epithelial head and neck tumors in oral cavity and mesopharynx, stages III or IV, eligible for radiant treatment. 2.Patients with epithelial head and neck tumors not eligible for surgical treatment or undergoing relapse upon inclusion. 3.EGF-R expression confirmation by immunohistochemistry. 4.Patient’s consent in writing. 5.Age from 18 to 75 years, of both sexes. 6.WHO Performance Status lower than or equal to 2. 7.Six month life expectancy. 8.Clinical laboratory parameters: Hb >10 g/l; total leukocytes over 4 x 109 cells/l; platelets > 100 x 109/L. Liver function within normal limits and/or patients with history of liver condition confirmed by TGP, TGO or alkaline phosphatase. Kidney function: serum creatinine?132 mmol/l.

Exclusion criteria

Exclusion criteria: 1.Non compliance with inclusion criteria. 2.Patients treated with murine R3 MaB. 3.Pregnancy or breastfeeding. 4.Decompensated chronic disease: cardiopathy, diabetes, high blood pressure. 5.History of hypersensitivity to this or any similar product. 6.Fever 7.Severe septic processes. 8.Acute or serious allergic conditions.

Design outcomes

Primary

Measure	Time frame
Antitumoral effect. Measuring time: 12 months.	—

Secondary

Measure	Time frame
Adverse reactions and maximum permissible dose. Measuring time: 12 months.	—

Countries

Cuba

Contacts

Public ContactTania Crombet Ramos

Center of Molecular Immunology (CIM)

taniac@cim.sld.cu

Outcome results

None listed

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