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A Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of ConvitVax in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:
A Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of ConvitVax in Metastatic Breast Cancer

Clinical Trial Summary

This is a proof-of-concept, single-center, non-randomized, open-label, phase 1b/2 study to evaluate the safety and efficacy of ConvitVax, a simple, low cost (of manufacture), personalized, potentially safe and effective breast cancer vaccine made of three components: autologous tumor cells homogenate obtained from 0.3 g of tumor tissue, 0.0625 mg of bacillus Calmette-Guérin Danish strain 1331 (BCG D1331), and 0.02% of formalin, for patients with metastatic breast cancer (MBC) except for brain metastases, leptomeningeal carcinomatosis, and/or spinal cord compression. The primary aim is to determine the overall safety and tolerability of ConvitVax when administered via an intradermal (id) injection as monotherapy in female patients with MBC who have failed at least one line of therapy. This study will give access to an immunotherapy, to underprivileged women with MBC, particularly in poor developing countries where patients may not have the opportunity to be treated with modern therapies or, in many cases, standard of care treatments. Breast cancer patients at Instituto de Oncología "Dr. Luis Razetti" (Oncological Institute "Dr. Luis Razetti") (IOLR) who meet the eligibility criteria will be consented and asked to have a biopsy of the primary tumor. This fragment will be divided for the preparation of each dose of the vaccine. A total of 40 patients with confirmed MBC will be treated with ConvitVax. The final volume per dose of the vaccine is 0.5 ml, with a total of 4 doses. ConvitVax will be applied via id injection with a 2-week interval between each dose. Patients will be monitored for disease recurrence and survival, for a period of 1 year after initiating the treatment.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06023277
Study type Interventional
Source Jacinto Convit World Organization Inc.
Contact Jeismar Carballo, PhD
Phone +34643794364
Email jcwo@jacintoconvit.org
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date April 1, 2024
Completion date March 31, 2027
View Details
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