Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04674306 | Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer | EARLY_PHASE1 | ACTIVE NOT_RECRUITING | 35 | — | — | Oct 1, 2021 | May 1, 2026 | May 23, 2025 | 1 | United States |
MTD of an α-lactalbumin vaccine in participants with operable triple-negative breast cancer
MTD of an α-lactalbumin vaccine in participants at risk for TNBC who are scheduled for prophylactic double mastectomy.
MTD of an α-lactalbumin vaccine in participants who are receiving adjuvant pembrolizumab following initial TNBC treatment.
| Arm | Type | Description |
|---|---|---|
| Treatment α-lactalbumin and zymosan | EXPERIMENTAL | Participants diagnosed with triple negative breast cancer will be treated with successively higher doses of α-lactalbumin and zymosan in a 3 + 3 trial design. Treatment will involve 3 vaccinations every 2 weeks. Participants will be enrolled into 1 of 5 different dose levels each comprised of cohorts of 1-6 participants until the MTD has been identified (intra-patient dose escalation not permitted), after which the MTD will be expanded to 6 participants. Successively lower doses will be expanded to 6 participants until the lowest DL associated with immune response has been expanded. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic) |
| Preventitive a-lactalbumin and zymosan | EXPERIMENTAL | Participants with a genetic risk for developing TNBC who plan to undergo prophylactic mastectomy will be treated with α-lactalbumin and zymosan at doses based on the TNBC cohort. Treatment will involve 3 vaccinations every 2 weeks. Participants enrolled in the prevention cohort will be enrolled at the dose level being used in the TNBC cohort if no DLTs above Grade 1 have been observed. If the TNBC cohort proceeds to the next dose level before another prevention cohort patient is enrolled, the next prevention patient will be enrolled on the next dose level along with the TNBC cohort. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic) |
| Standard of Care with a-lactalbumin and zymosan | EXPERIMENTAL | Participants undergoing chemo-immunotherapy for operable triple-negative breast cancer will be treated with α-lactalbumin concurrently with standard of care adjuvant pembrolizumab after having completed all pre- and postoperative chemotherapy and radiation therapy, with the exception of Xeloda/capecitabine at provider discretion. Treatment will involve 3 vaccinations every 2 weeks. Participants enrolled in the Pembrolizumab cohort will be enrolled at the proper Optimal Immunologic Dose as defined by the TNBC and preventative cohorts and based on information available at the time of study entry. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic) |
| Name | Type | Description |
|---|---|---|
| α-lactalbumin vaccine | BIOLOGICAL | 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) |
| Zymosan | BIOLOGICAL | 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) |
Inclusion Criteria: Triple Negative Cohort: * Histologically proven invasive breast cancer. * Primary tumor must be ER-negative (ER in \<1% of cells), PR-negative (PR in \<1% of cells), and HER2-negative (0-1+ by IHC or FISH ratio\<2.0 with signal number \<6/cell), or consistent with contemporary ...