ConvitVax for Breast Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Jacinto Convit World Organization Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for women over 18 with metastatic breast cancer who have failed at least one standard treatment. They must not be pregnant or breastfeeding and agree to use effective contraception. Patients should not have brain metastases, severe liver or blood issues, an ECOG performance status of ≥1, life expectancy under 3 months, active infections, certain other cancers within the last 3 years, known HIV/AIDS or hepatitis A/B/C infection.

Inclusion Criteria

Ability to understand and willingness to sign written ICFs

My breast cancer diagnosis was confirmed through tissue analysis.

You have a tumor that can be measured and is at least 1 cm in two dimensions.

+5 more

Exclusion Criteria

Current participation in another clinical trial

Previous enrollment in this study

Current pregnancy or breastfeeding

+27 more

Participant Groups

ConvitVax is being tested as a potential vaccine for advanced breast cancer. It's made from the patient's own tumor cells mixed with BCG (a tuberculosis vaccine) and formalin. The study involves giving patients four doses via skin injection every two weeks and monitoring them for a year.

1Treatment groups

Experimental Treatment

Group I: ConvitVaxExperimental Treatment1 Intervention

ConvitVax is a vaccine made of three components: autologous tumor cells homogenate obtained from 0.3 g of tumor tissue, 0.0625 mg of BCG D1331, and 0.02% of formalin. There is no dose escalation in this study. Four doses of 0.5 mL of ConvitVax will be applied via id injection with a 2-week interval between each dose.