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    DRUG:

    tovecimig (CTX-009)

    i
    Other names: CTX-009, ABL 001, NOV1501, TR009, NOV150101, TR-009, ES104, ABL001, HDB001A, HD-B001A, ABL-001, CTX009, CTX 009, ES-104, ES 104, HD B001A, NOV-1501, NOV 1501, NOV-150101, NOV 150101, TR 009
    Company:
    ABL Bio, Compass Therap, Elpiscience, Handok
    Drug class:
    VEGF-A inhibitor, DLL4 inhibitor
    Related drugs:
    5ms
    COMPANION-003: A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=49, Completed, Compass Therapeutics | Active, not recruiting --> Completed | N=84 --> 49
    Trial completion • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    HER-2 positive • BRAF V600E • MSI-H/dMMR • BRAF V600
    |
    tovecimig (CTX-009)
    9ms
    COMPANION-003: A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=84, Active, not recruiting, Compass Therapeutics | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    HER-2 positive • BRAF V600E • MSI-H/dMMR • BRAF V600
    |
    tovecimig (CTX-009)
    10ms
    CTX-009 with Gemcitabine, Cisplatin, and Durvalumab As First-line Therapy in Patients with Unresectable or Metastatic Biliary Tract Cancers (clinicaltrials.gov)
    P1/2, N=50, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • tovecimig (CTX-009)
    10ms
    A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients (clinicaltrials.gov)
    P1/2, N=41, Terminated, Handok Inc. | N=92 --> 41 | Trial completion date: Jul 2025 --> Jan 2025 | Active, not recruiting --> Terminated; Change of Development Plan
    Enrollment change • Trial completion date • Trial termination
    |
    paclitaxel • irinotecan • tovecimig (CTX-009)
    over1year
    A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) (clinicaltrials.gov)
    P2/3, N=150, Active, not recruiting, Compass Therapeutics | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    paclitaxel • tovecimig (CTX-009)
    over1year
    CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers (clinicaltrials.gov)
    P1/2, N=50, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial • Metastases
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • tovecimig (CTX-009)
    over1year
    COMPANION-003: A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=84, Active, not recruiting, Compass Therapeutics | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    HER-2 positive • BRAF V600E • MSI-H/dMMR • BRAF V600
    |
    tovecimig (CTX-009)
    almost2years
    COMPANION-003: A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=84, Recruiting, Compass Therapeutics | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    HER-2 positive • BRAF V600E • MSI-H/dMMR • BRAF V600
    |
    tovecimig (CTX-009)
    almost2years
    A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) (clinicaltrials.gov)
    P2/3, N=150, Recruiting, Compass Therapeutics | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Jul 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    paclitaxel • tovecimig (CTX-009)
    almost2years
    A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients (clinicaltrials.gov)
    P1/2, N=92, Active, not recruiting, Handok Inc. | Recruiting --> Active, not recruiting | Phase classification: P1b/2a --> P1/2 | Trial primary completion date: Aug 2024 --> Nov 2023
    Enrollment closed • Phase classification • Trial primary completion date • Combination therapy • Metastases
    |
    paclitaxel • irinotecan • tovecimig (CTX-009)
    almost2years
    A phase 2/3 randomized study of CTX-009 combination in 2L biliary tract cancer: COMPANION-002. (ASCO-GI 2024)
    Systemic chemotherapy usually begins with gemcitabine, platinum agents, and a checkpoint inhibitor followed by 5-FU and oxaliplatin, irinotecan or a taxane...150 patients will be randomized in a 2:1 ratio to receive either CTX-009 plus paclitaxel or paclitaxel alone...Key secondary objectives include overall survival, progression-free survival, and duration of response. Clinical trial information: 251040.
    Clinical • P2/3 data
    |
    NOTCH1 (Notch 1)
    |
    VEGFA overexpression
    |
    gemcitabine • paclitaxel • 5-fluorouracil • oxaliplatin • irinotecan • tovecimig (CTX-009)
    over3years
    A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=84, Not yet recruiting, Compass Therapeutics
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    RAS wild-type
    |
    tovecimig (CTX-009)