NCT04674306

Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer

Phase I Trial of Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Patients With Non-Metastatic Triple-Negative Breast Cancer at High Risk of Recurrence

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: George T. Budd · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer, participants who are of cancer-free but may be at risk for triple-negative breast cancer, and for participants who are receiving adjuvant pembrolizumab following initial triple negative breast cancer treatment.

Detailed description

This is an open-label, phase I dose-escalation trial that will be performed on three successive cohorts. The first cohort is comprised of participants with high-risk triple-negative breast cancer. The second is made up of participants scheduled to undergo bilateral prophylactic mastectomy due to their genetic risk of triple-negative breast cancer. The third cohort is comprised of participants who have had treatment for their triple-negative breast cancer treatment, receiving adjuvant pembrolizumab. These cohorts will be treated with successively higher doses of α-lactalbumin and zymosan. This aLA breast cancer vaccine is an investigational (experimental) drug that the study team believes will work by stimulating the immune system to fight the participant's cancer, in a way similar to the way the immune system fights off an infection after a vaccination for that infection. α-lactalbumin Vaccine is experimental because it is not approved by the Food and Drug Administration (FDA). A traditional "3+3" Phase I trial design will be employed for the cohorts to determined the Maximum Tolerated Dose (MTD). After identification of the MTD, if at least 1 participant has an immunologic response (correlative measurement), successively lower dose levels will be expanded to a total of 6 participants and immunologic response assessed. Enrollment will stop if a dose level is reached for which no responses are observed. Dose-Limiting toxicities (DLTs) in 2 or more of 6 participants, the next lower dose will be considered the new MTD. Objectives are to determine MTD, DLT incidence, and Lowest Immunologic Dose (LID) for each cohort. Toxicity will be assessed every 2 weeks until day 56 and at day 84 or at off-study. Participants will be offered participation in long-term follow-up involving contact or in-person follow-up for late toxicity and survival every 3 months for 2 years, every 6 months for an additional 3 years, and then annually for 10 years.

Conditions

• Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer
• TNBC - Triple-Negative Breast Cancer
• Residual Disease

Interventions

Type	Name	Description
BIOLOGICAL	α-lactalbumin vaccine	α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). DL1: 10 mcg DL Original 2: 100 mcg DL2: 100 mcg DL3: 500 mcg D1b: 50 mcg D1e: 10 mcg D1f: 20 mcg D1g: 20 mcg (D1g will only be utilized if D1c is deemed too toxic)
BIOLOGICAL	Zymosan	Adjuvant used in vaccine preparation DL1: 10 mcg DL Original 2: 100 mcg DL2: 10 mcg DL3: 10 mcg D1b: 10 mcg D1e: 20 mcg D1f: 20 mcg D1g: 1o mcg (D1g will only be utilized if D1c is deemed too toxic)

Timeline

• Start date: 2021-10-01
• Primary completion: 2025-11-01
• Completion: 2026-05-01
• First posted: 2020-12-19
• Last updated: 2025-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study