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

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.

Timeline

Start

2024-04-01

Primary completion

2025-03-31

Completion

2027-03-31

Publications

• Background Duarte C MA, Carballo O JM, De Gouveia YM, Garcia A, Ruiz D, Gledhill T, Gonzalez-Marcano E, Convit AF. Toxicity evaluation of ConvitVax breast cancer immunotherapy. Sci Rep. 2021 Jun 16;11(1):12669. doi: 10.1038/s41598-021-91995-6.
• Background Godoy-Calderon MJ, Salazar V, Gonzalez-Marcano E, Convit AF. Autologous tumor cells/bacillus Calmette-Guerin/formalin-based novel breast cancer vaccine induces an immune antitumor response. Oncotarget. 2018 Apr 17;9(29):20222-20238. doi: 10.18632/oncotarget.25044. eCollection 2018 Apr 17.
• Background Godoy-Calderon MJ, Gonzalez-Marcano E, Carballo J, Convit AF. Evaluation of a ConvitVax/anti-PD-1 combined immunotherapy for breast cancer treatment. Oncotarget. 2019 Nov 12;10(61):6546-6560. doi: 10.18632/oncotarget.27283. eCollection 2019 Nov 12.
• Background Convit J, Montesinos H, Oviedo H, Romero G, Maccarone B, Essenfeld E, Convit A, Palacios LE. Autologous tumor lysate/Bacillus Calmette-Guerin immunotherapy as an adjuvant to conventional breast cancer therapy. Clin Transl Oncol. 2015 Nov;17(11):884-7. doi: 10.1007/s12094-015-1320-0. Epub 2015 Jun 16.
• Background Convit J, Pinardi ME, Rodriguez Ochoa G, Ulrich M, Avila JL, Goihman M. Elimination of Mycobacterium leprae subsequent to local in vivo activation of macrophages in lepromatous leprosy by other mycobacteria. Clin Exp Immunol. 1974 Jun;17(2):261-5.
• Background Convit J, Aranzazu N, Pinardi M, Ulrich M. Immunological changes observed in indeterminate and lepromatous leprosy patients and Mitsuda-negative contacts after the inoculation of a mixture of Mycobacterium leprae and BCG. Clin Exp Immunol. 1979 May;36(2):214-20.
• Background Convit J, and Ulrich M. Desarrollo de una autovacuna + BCG y su posible uso en el tratamiento del cáncer. Gaceta Médica Caracas. 2006; 114, 300-304.
• Background Convit, J. Inmunidad celular y su importancia en el cáncer de la mama. Gaceta Médica Caracas. 2008; 116, 248-249.

Drugs

Indications