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    DRUG:

    trebananib (AMG 386)

    i
    Other names: AMG 386, 20060439, AMG386
    Company:
    Amgen
    Drug class:
    Angiopoietin 1 inhibitor, Angiopoietin 2 inhibitor, TIE-2 antagonist
    Related drugs:
    5ms
    Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=59, Completed, Dana-Farber Cancer Institute | Active, not recruiting --> Completed | Trial completion date: Aug 2026 --> Dec 2024 | Trial primary completion date: Feb 2026 --> Dec 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    Keytruda (pembrolizumab) • trebananib (AMG 386)
    8ms
    Pembrolizumab (anti-PD-1) and AMG386 (angiopoietin-2 (Ang-2) in Patients with Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Aug 2025 --> Aug 2026 | Trial primary completion date: Feb 2025 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    Keytruda (pembrolizumab) • trebananib (AMG 386)
    12ms
    Second-line systemic treatment for metastatic colorectal cancer: A systematic review and Bayesian network meta-analysis based on RCT. (PubMed, PLoS One)
    For most people, FOLFOX + Bevacizumab may be the best second-line systemic treatment regimen for mCRC. For RAS-mutant populations, FOLFIRI + Bevacizumab + Panitumumab is recommended. However, the therapeutic effect may be affected by the patient's physiological state, and clinicians should apply it based on actual conditions.
    Clinical • Retrospective data • Review • Journal • Metastases
    |
    RAS (Rat Sarcoma Virus)
    |
    RAS mutation • RAS wild-type
    |
    Avastin (bevacizumab) • erlotinib • 5-fluorouracil • Vectibix (panitumumab) • irinotecan • leucovorin calcium • trebananib (AMG 386)
    1year
    A Phase 1 Trial of Trebananib, an Angiopoietin 1 and 2 Neutralizing Peptibody, Combined with Pembrolizumab in Patients with Advanced Ovarian and Colorectal Cancer. (PubMed, Cancer Immunol Res)
    After development of acquired resistance, biopsy of one patient's KRAS wild-type, ERBB2 amplified tumor showed a substantial decline in tumor-associated T cells and an increase in immunosuppressive intratumoral macrophages. Future studies are needed to carefully assess whether clinicogenomic features, such as lack of liver metastases, ERBB2 amplification, and left-sided tumors, can predict increased sensitivity to PD1 immunotherapy combinations.
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • POLE (DNA Polymerase Epsilon)
    |
    HER-2 amplification • POLE mutation • KRAS wild-type • RAS wild-type
    |
    Keytruda (pembrolizumab) • trebananib (AMG 386)
    over1year
    Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    Keytruda (pembrolizumab) • trebananib (AMG 386)
    almost2years
    Angiopoietin-2 and the Vascular Endothelial Growth Factor Promote Migration and Invasion in Hepatocellular Carcinoma- and Intrahepatic Cholangiocarcinoma-Derived Spheroids. (PubMed, Biomedicines)
    Inhibitors targeting ANG-2 (Trebananib) and the VEGF (Bevacizumab) effectively blocked the migration ability of spheroids that had been stimulated with rh-ANG-2 and rh-VEGF. Overall, our findings highlight the critical role played by ANG-2 and the VEGF in enhancing the ability of HCC- and iCCA-derived spheroids to migrate and invade, which are key processes in cancer progression.
    Journal
    |
    VEGFA (Vascular endothelial growth factor A) • CDH1 (Cadherin 1) • VIM (Vimentin) • CDH2 (Cadherin 2)
    |
    Avastin (bevacizumab) • trebananib (AMG 386)
    almost2years
    Neoadjuvant trebananib plus paclitaxel-based chemotherapy for stage II/III breast cancer in the adaptively randomized I-SPY2 trial - Efficacy and biomarker discovery. (PubMed, Clin Cancer Res)
    The Ang/Tie2 axis inhibitor trebananib combined with standard neoadjuvant therapy increased estimated pCR rates across HR-negative and MP2 subtypes, with probabilities of superiority >90%. Further study of Ang/Tie2 receptor axis inhibitors in validated, biomarker-predicted sensitive subtypes is warranted.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8)
    |
    HER-2 positive • HER-2 negative • HER-2 expression • CD8 expression
    |
    MammaPrint
    |
    Herceptin (trastuzumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • trebananib (AMG 386)
    over2years
    Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Dana-Farber Cancer Institute | Trial primary completion date: Feb 2023 --> Feb 2024
    Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    Keytruda (pembrolizumab) • trebananib (AMG 386)
    over3years
    Molecular subtype to predict pathologic complete response in HER2-positive breast cancer in the I-SPY2 trial. (ASCO 2022)
    P2 | "The I-SPY2 platform trial tests novel agents given neoadjuvantly with a backbone of taxol (T) and trastuzumab (H) followed by doxorubicin and cyclophosphamide. Agents investigated in HER2+ bc were TH (control), MK2206, AMG386, pertuzumab (P), neratinib (N (given in place of H), and TDM1+P (given in place of TH)... pCR rates for patients with HER2+ bc treated with investigational agents, particularly dual HER2-blockade, were promising. Molecular response predictive subtype classification provides insight on how to better target therapy. The HER2+/Luminal group had low pCR rates with dual HER2-blockade but may have higher pCR rate with the addition of an AKT inhibitor and identifies a subgroup of HER2+ tumors in need of novel approaches."
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • DRD (DNA Repair Deficiency)
    |
    HER-2 positive • DDR • DRD
    |
    paclitaxel • Nerlynx (neratinib) • Perjeta (pertuzumab) • doxorubicin hydrochloride • cyclophosphamide • MK-2206 • trebananib (AMG 386)
    over4years
    I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov)
    P2; Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Dec 2025 --> Dec 2030
    Trial completion date • Trial primary completion date • Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • ER negative
    |
    TargetPrint®
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • Verzenio (abemaciclib) • cyclophosphamide • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • letrozole • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • ganitumab (AMG 479) • amcenestrant (SAR439859) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • Cosela (trilaciclib) • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • trebananib (AMG 386)
    over4years
    Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2020 --> Feb 2023
    Clinical • Enrollment closed • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    Keytruda (pembrolizumab) • trebananib (AMG 386)
    almost5years
    I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov)
    P2, N=4000, Recruiting, QuantumLeap Healthcare Collaborative | Phase classification: P1 --> P2
    Phase classification
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • ER negative
    |
    MammaPrint • TargetPrint®
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • Verzenio (abemaciclib) • cyclophosphamide • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • letrozole • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • ganitumab (AMG 479) • amcenestrant (SAR439859) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • Cosela (trilaciclib) • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • trebananib (AMG 386)