NCT06023277

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jacinto Convit World Organization Inc. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ConvitVax	ConvitVax is a personalized vaccine designed to treat women with breast cancer. The vaccine is composed of three widely commonly used components: autologous tumor cells obtained from the patient's own tumor tissue, BCG D1331, plus a low concentration of formalin.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-03-31
• Completion: 2027-03-31
• First posted: 2023-09-05
• Last updated: 2023-09-05

Locations

3 sites across 2 countries: United States, Venezuela

Regulatory

• FDA-regulated drug study