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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
TPIV100
i
Other names: HER-2/neu vaccine, TPIV100
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News alerts, weekly reports and conference planners
Company:
Marker Therap
Drug class:
HER2 inhibitor
Related drugs:
over2years
Phase II trial to evaluate immune-related biomarkers for pathological response in stage II-III HER2-positive breast cancer receiving neoadjuvant chemotherapy with subsequent randomization to multi-epitope HER2 vaccine versus placebo in patients with residual disease post-neoadjuvant chemotherapy. (ASCO 2022)
Eligible patients include those with stage II-III HER2+ with residual disease, in the breast and/or lymph nodes, after trastuzumab ± pertuzumab-based NAC, with ECOG PS ≤ 2 and adequate organ function...TPIV100 or placebo, in combination with GM-CSF, will be given concurrently with T-DM1...Currently, 20 patients in the run-in phase have been enrolled. Enrollment to the randomized phase II portion is expected to begin in March 2022.
Clinical • P2 data
|
HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • CSF2 (Colony stimulating factor 2)
|
HER-2 positive
|
Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • TPIV100
over4years
TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery (clinicaltrials.gov)
P2, N=480, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 positive
|
Herceptin (trastuzumab) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Leukine (sargramostim) • TPIV100
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