NCT06023277

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

Not yet recruiting Phase 1, PHASE2 Last updated 5 September 2023

What this trial tests

Phase 1, PHASE2 trial testing ConvitVax in Metastatic Breast Cancer in 40 participants. Not yet recruiting.

Timeline

1 April 2024

Primary endpoint
31 March 2025

31 March 2027

Quick facts

Lead sponsor	Jacinto Convit World Organization Inc.
Phase	Phase 1, PHASE2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 April 2024
Primary completion	31 March 2025
Estimated completion	31 March 2027
Sites	3 locations across Venezuela, United States

Drugs / interventions tested

• ConvitVax — full drug profile →

Conditions studied

• Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Jacinto Convit World Organization Inc. — full company profile →

Who can join

18 and older, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer vaccines: an update on recent achievements and prospects for cancer therapy.
   Chekaoui A, Garofalo M, Gad B, Staniszewska M, et al · · 2024 · cited 8× · PMID 39720956 · DOI 10.1007/s10238-024-01541-7
2. Targeting pattern recognition receptors for cancer therapy: Mechanisms and strategies.
   Ouyang D, Chen R, Xie H, Yang X, et al · · 2025 · cited 1× · PMID 41311391 · DOI 10.1016/j.apsb.2025.09.007
3. Harnessing Vaccines in the Treatment of Solid Tumors: Advances, Challenges, and Future Directions.
   Iranzo J, Giordano E, Marsicano RM, Trapani D, et al · · 2026 · PMID 41746058 · DOI 10.3390/vaccines14020135