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    DRUG:

    Trazimera (trastuzumab-qyyp)

    i
    Other names: PF-5280014, PF-05280014
    Company:
    Pfizer
    Drug class:
    HER2 inhibitor
    Related drugs:
    16d
    UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1/2, N=18, Recruiting, Jonsson Comprehensive Cancer Center | Phase classification: P1b --> P1/2 | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2025
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 amplification
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • Kisqali (ribociclib) • fulvestrant • Tukysa (tucatinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    29d
    Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy (clinicaltrials.gov)
    P3, N=2014, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive • HR positive
    |
    Trazimera (trastuzumab-qyyp)
    1m
    Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=315, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    carboplatin • docetaxel • Trazimera (trastuzumab-qyyp) • goserelin acetate • TQB2440 (pertuzumab biosimilar) • BCD-178 (pertuzumab biosimilar)
    1m
    Bispecific immune cell engager enhances the anticancer activity of CD16+ NK cells and macrophages in vitro, and eliminates cancer metastasis in NK humanized NOG mice. (PubMed, J Immunother Cancer)
    Collectively, our in vivo findings underscore BiKE:E5C1's potential as an immune cell engager capable of activating immune cells for cancer cell elimination, thereby expanding the arsenal of available BiKEs for cancer immunotherapy.
    Preclinical • Journal • Immune cell
    |
    HER-2 (Human epidermal growth factor receptor 2) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    Herceptin (trastuzumab) • Trazimera (trastuzumab-qyyp)
    2ms
    SCHOLAR-2: Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction (clinicaltrials.gov)
    P2, N=130, Recruiting, Population Health Research Institute | Trial completion date: Dec 2025 --> Jun 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    2ms
    Biosimilar in Breast Cancer: A Narrative Review. (PubMed, Cureus)
    Trastuzumab biosimilars, such as CT-P6, Ontruzant®, ABP 980, and PF-05280014, have shown efficacy in treating HER2-positive metastatic BCs, presenting a viable alternative to the reference product. Monoclonal biosimilars present a promising avenue in BC therapy, demonstrating efficacy, safety, and potential cost savings. The integration of biosimilars into cancer treatment strategies offers a means to improve accessibility to effective care while addressing economic considerations in healthcare.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Herzuma (trastuzumab-pkrb) • Ontruzant (trastuzumab-dttb) • Kanjinti (trastuzumab-anns) • Trazimera (trastuzumab-qyyp)
    2ms
    Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    Trazimera (trastuzumab-qyyp) • TQB2440 (pertuzumab biosimilar) • BCD-178 (pertuzumab biosimilar)
    2ms
    NCI-2016-00570: Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp)
    2ms
    TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, Mayo Clinic | Recruiting --> Active, not recruiting | N=80 --> 19
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • paclitaxel • fulvestrant • letrozole • anastrozole • exemestane • Trazimera (trastuzumab-qyyp) • denifanstat (TVB-2640)
    3ms
    An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (clinicaltrials.gov)
    P4, N=10, Recruiting, City of Hope Medical Center | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Feb 2025 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trazimera (trastuzumab-qyyp)
    3ms
    SWOG S1613: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov)
    P2, N=240, Active, not recruiting, SWOG Cancer Research Network | Trial completion date: Jun 2024 --> Nov 2024
    Trial completion date • Surgery • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    BRAF V600E • HER-2 amplification • BRAF V600 • KRAS exon 4 mutation • BRAF exon 15 mutation
    |
    Herceptin (trastuzumab) • Erbitux (cetuximab) • Perjeta (pertuzumab) • irinotecan • Trazimera (trastuzumab-qyyp)
    3ms
    SMMART Adaptive Clinical Treatment (ACT) Trial (clinicaltrials.gov)
    P1, N=0, Withdrawn, OHSU Knight Cancer Institute | N=25 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • EGFR positive
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • carboplatin • Rozlytrek (entrectinib) • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • capecitabine • Piqray (alpelisib) • Zejula (niraparib) • albumin-bound paclitaxel • fulvestrant • irinotecan • Halaven (eribulin mesylate) • letrozole • vinorelbine tartrate • Herzuma (trastuzumab-pkrb) • anastrozole • Erivedge (vismodegib) • Trazimera (trastuzumab-qyyp) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    5ms
    UCLA l-08: Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=26, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2024 --> Dec 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • AXL (AXL Receptor Tyrosine Kinase)
    |
    EGFR mutation • EGFR L858R • HER-2 expression • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Portrazza (necitumumab)
    5ms
    Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P1/2, N=43, Active, not recruiting, M.D. Anderson Cancer Center | Phase classification: P1b --> P1/2
    Phase classification • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • PTEN mutation + HR positive
    |
    paclitaxel • Nerlynx (neratinib) • Perjeta (pertuzumab) • doxorubicin hydrochloride • cyclophosphamide • daunorubicin • Trazimera (trastuzumab-qyyp)
    6ms
    Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=16, Recruiting, University of Washington | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial primary completion date • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)
    |
    Herceptin (trastuzumab) • paclitaxel • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • EG1206A (pertuzumab biosimilar)
    6ms
    Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    Trazimera (trastuzumab-qyyp) • TQB2440 (pertuzumab biosimilar) • BCD-178 (pertuzumab biosimilar) • EG1206A (pertuzumab biosimilar)
    6ms
    Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1/2, N=2, Terminated, National Cancer Institute (NCI) | N=12 --> 2 | Recruiting --> Terminated; Inadequate accrual rate
    Enrollment change • Trial termination • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog)
    |
    HR positive • PIK3CA mutation • PTEN mutation
    |
    Herceptin (trastuzumab) • Aliqopa (copanlisib) • Trazimera (trastuzumab-qyyp) • TQB2440 (pertuzumab biosimilar) • BCD-178 (pertuzumab biosimilar) • EG1206A (pertuzumab biosimilar)
    8ms
    Safety and Efficacy of Trastuzumab BS (clinicaltrials.gov)
    P=N/A, N=150, Active, not recruiting, Pfizer | Not yet recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Trazimera (trastuzumab-qyyp)
    8ms
    Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer (clinicaltrials.gov)
    P3, N=203, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    carboplatin • paclitaxel • Trazimera (trastuzumab-qyyp)
    9ms
    NCI-2016-00570: Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jun 2023 --> Dec 2023
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp)
    9ms
    SMMART Adaptive Clinical Treatment (ACT) Trial (clinicaltrials.gov)
    P1, N=25, Not yet recruiting, OHSU Knight Cancer Institute | Phase classification: P2 --> P1 | N=131 --> 25
    Phase classification • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • EGFR positive
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • carboplatin • Rozlytrek (entrectinib) • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • capecitabine • Piqray (alpelisib) • Zejula (niraparib) • albumin-bound paclitaxel • fulvestrant • irinotecan • Halaven (eribulin mesylate) • letrozole • vinorelbine tartrate • Herzuma (trastuzumab-pkrb) • anastrozole • Erivedge (vismodegib) • Trazimera (trastuzumab-qyyp) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • EG1206A (pertuzumab biosimilar)
    10ms
    FASN Inhibitor TVB-2640 and Trastuzumab in Combination With Paclitaxel or Endocrine Therapy for the Treatment of HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Mayo Clinic | Trial primary completion date: Jul 2023 --> Jul 2024
    Trial primary completion date
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • paclitaxel • fulvestrant • letrozole • anastrozole • exemestane • Trazimera (trastuzumab-qyyp) • denifanstat (TVB-2640)
    10ms
    Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=16, Recruiting, University of Washington | Trial primary completion date: Jun 2023 --> Oct 2023
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • IL10 (Interleukin 10) • IGFBP2 (Insulin-like growth factor binding protein 2)
    |
    Herceptin (trastuzumab) • paclitaxel • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • EG1206A (pertuzumab biosimilar)
    10ms
    Chemotherapy Before Surgery and Tissue Sample Collection in Patients With Stage IIA-IIIC Breast Cancer (clinicaltrials.gov)
    P=N/A, N=132, Active, not recruiting, Albert Einstein College of Medicine | Trial completion date: Jun 2023 --> Dec 2026 | Trial primary completion date: Jun 2023 --> Dec 2025
    Trial completion date • Trial primary completion date • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Trazimera (trastuzumab-qyyp)
    12ms
    Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer (clinicaltrials.gov)
    P1, N=39, Suspended, Mayo Clinic | Trial completion date: May 2023 --> May 2026 | Trial primary completion date: Apr 2023 --> Apr 2025
    Trial completion date • Trial primary completion date • FDG PET • Metastases
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • gemcitabine • Rituxan (rituximab) • Gazyva (obinutuzumab) • Aliqopa (copanlisib) • Darzalex (daratumumab) • Herzuma (trastuzumab-pkrb) • carfilzomib • Istodax (romidepsin) • Trazimera (trastuzumab-qyyp) • Beleodaq (belinostat)
    1year
    Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy (clinicaltrials.gov)
    P1/2, N=31, Completed, University of Washington | Unknown status --> Completed
    Trial completion • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma) • NCAM1 (Neural cell adhesion molecule 1) • LAMP1 (Lysosomal Associated Membrane Protein 1)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp) • AST-301
    1year
    UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1b, N=18, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    IL6 (Interleukin 6) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
    |
    HER-2 amplification • PTPRC expression • IL6 expression
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • Kisqali (ribociclib) • fulvestrant • Tukysa (tucatinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    1year
    A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) (clinicaltrials.gov)
    P2; Unknown status --> Completed | Trial completion date: Dec 2021 --> May 2022 | Trial primary completion date: Aug 2021 --> May 2022
    Combination therapy • Trial completion date • Trial primary completion date • Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 amplification • PGR positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Keytruda (pembrolizumab) • Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp)
    1year
    NCI-2016-00570: Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2021 --> Jun 2023
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp)
    1year
    CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (clinicaltrials.gov)
    P2, N=2156, Recruiting, ECOG-ACRIN Cancer Research Group | Trial completion date: Feb 2023 --> Dec 2038 | Trial primary completion date: Feb 2023 --> Oct 2026
    Trial completion date • Trial primary completion date • Surgery • Pre-surgery
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • albumin-bound paclitaxel • Trazimera (trastuzumab-qyyp)
    1year
    An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (clinicaltrials.gov)
    P4, N=10, Recruiting, City of Hope Medical Center | Trial completion date: Aug 2023 --> Feb 2025 | Trial primary completion date: Aug 2023 --> Feb 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trazimera (trastuzumab-qyyp)
    over1year
    ACCRU-GI-2003: Tucatinib Combined With Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study (clinicaltrials.gov)
    P2; Initiation date: Nov 2022 --> Mar 2023
    Trial initiation date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • BRAF mutation • HER-2 amplification • PIK3CA mutation • BRAF V600
    |
    Guardant360® CDx
    |
    Tukysa (tucatinib) • Lonsurf (trifluridine/tipiracil) • Trazimera (trastuzumab-qyyp)
    over1year
    Bispecific killer cell engager with high affinity and specificity toward CD16a on NK cells for cancer immunotherapy. (PubMed, Front Immunol)
    The cytotoxicity data also showed that the developed BiKE induces higher ADCC to both ovarian and breast cancer cells in comparison to Trazimera™ (trastuzumab). According to the BLI data, BiKE:HER2/CD16 recognizes a different epitope on CD16a antigen than IgG-based mAbs; thus, it provides the opportunity for not only monotherapy but also combination therapy with other antibody drugs such as checkpoint inhibitors and antibody-drug conjugates. Taken together, the data demonstrate the creation of a novel BiKE with high affinity and specificity toward CD16a on NK cells with the potential to elicit a superior therapeutic response in patients with HER2 cancer than existing anti-HER2 mAbs.
    Journal
    |
    FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    Herceptin (trastuzumab) • Trazimera (trastuzumab-qyyp)
    over1year
    NRG-BR004: Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=600, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2023 --> Apr 2024 | Trial primary completion date: Jan 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor) • IL2 (Interleukin 2)
    |
    HER-2 positive
    |
    Tecentriq (atezolizumab) • paclitaxel • docetaxel • Trazimera (trastuzumab-qyyp) • EG1206A (pertuzumab biosimilar)
    over1year
    Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) for Recurrent, Metastatic, or Unresectable HER2-Positive Salivary Gland Cancer (clinicaltrials.gov)
    P2, N=116, Recruiting, NRG Oncology | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • docetaxel • Kadcyla (ado-trastuzumab emtansine) • Trazimera (trastuzumab-qyyp)
    over1year
    SWOG S1613: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov)
    P2, N=240, Active, not recruiting, Southwest Oncology Group | Trial primary completion date: Nov 2023 --> Nov 2022
    Trial primary completion date • Surgery • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    BRAF V600E • HER-2 amplification • BRAF V600 • KRAS exon 4 mutation • BRAF exon 15 mutation
    |
    Herceptin (trastuzumab) • Erbitux (cetuximab) • Perjeta (pertuzumab) • irinotecan • Trazimera (trastuzumab-qyyp)
    over1year
    Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=26, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Portrazza (necitumumab)
    over1year
    NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov)
    P2, N=6452, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    MSI (Microsatellite instability) • CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Herceptin (trastuzumab) • Mekinist (trametinib) • Xalkori (crizotinib) • Tagrisso (osimertinib) • Gilotrif (afatinib) • Ibrance (palbociclib) • dasatinib • Tafinlar (dabrafenib) • Vitrakvi (larotrectinib) • Sutent (sunitinib) • Kadcyla (ado-trastuzumab emtansine) • Balversa (erdafitinib) • Mektovi (binimetinib) • adavosertib (AZD1775) • Truqap (capivasertib) • Aliqopa (copanlisib) • fexagratinib (ABSK091) • sapanisertib (CB-228) • ipatasertib (RG7440) • taselisib (GDC-0032) • ulixertinib (BVD-523) • Erivedge (vismodegib) • Trazimera (trastuzumab-qyyp) • GSK2636771 • defactinib (VS-6063) • relatlimab (BMS-986016) • EG1206A (pertuzumab biosimilar)
    over1year
    SWOG S1613: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov)
    P2, N=240, Active, not recruiting, Southwest Oncology Group | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Nov 2022 --> Nov 2023
    Trial completion date • Trial primary completion date • Surgery • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    BRAF V600E • HER-2 amplification • BRAF V600 • KRAS exon 4 mutation • BRAF exon 15 mutation
    |
    Herceptin (trastuzumab) • Erbitux (cetuximab) • Perjeta (pertuzumab) • irinotecan • Trazimera (trastuzumab-qyyp)
    over1year
    An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (clinicaltrials.gov)
    P4, N=10, Recruiting, City of Hope Medical Center | Initiation date: Oct 2022 --> Jan 2023
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trazimera (trastuzumab-qyyp)
    over1year
    4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer (clinicaltrials.gov)
    P1b, N=18, Completed, George W. Sledge Jr. | Active, not recruiting --> Completed | Trial completion date: Oct 2021 --> Feb 2022
    Trial completion • Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Herceptin (trastuzumab) • Kadcyla (ado-trastuzumab emtansine) • Trazimera (trastuzumab-qyyp) • utomilumab (PF-05082566)
    over1year
    An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (clinicaltrials.gov)
    P4, N=10, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trazimera (trastuzumab-qyyp)