For Healthcare Professionals

Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies

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About the study

This is a phase I/II, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of CB-103.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Disease
  2. Patients with histologically or cytologically confirmed solid tumours (breast cancer (triple negative breast cancer [TNBC], ER+/-, HER2+/-), gastrointestinal (GI) cancers (resistant to oxaliplatin or irinotecan-based therapy colorectal cancer [CRC]), osteosarcoma, adenoid cystic carcinoma (ACC), and malignant glomus tumour) that are surgically unresectable, locally advanced, or metastatic and whose disease has progressed on at least one line of systemic therapy (with the exception of ACC patients who are allowed to be systemic treatment-naïve) and for whom no established therapeutic alternatives exist. Any other solid cancer (including lymphoma) with a confirmed NOTCH1-4 activating mutation or genetic lesion.
  3. Relapsed or refractory (r/r) T-cell acute lymphoblastic leukaemia (T-ALL) or lymphoma (T-LBL) with a confirmed NOTCH pathway activation. Refractory patients are defined as T-ALL/T-LBL patients with ≥ 5% bone marrow blasts, and/or concomitant extramedullary involvement, who have not achieved a CR after standard induction/consolidation therapy attempt.
  4. Demography: men and women ≥ 18 years old
  5. Adequate organ function and laboratory results
  6. Adequate contraceptive measures
  7. Signed informed consent

EXCLUSION CRITERIA

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.
    Phone iconCall +41 79 9441580Email iconEmail Study Center

    Study’s details


    Contition

    Adenoid Cystic Carcinoma,Advanced or Metastatic Solid Tumours,Breast Cancer,Cervical Cancer,Cholangiocellular Carcinoma,Colorectal Cancer,Desmoid Tumour,Gastric Cancer,Glioblastoma Multiforme,Glomus Tumor, Malignant,Hepatocellular Carcinoma,Hodgkin Lymphoma,Melanoma,Multiple Myeloma,NSCLC,Non-hodgkin Lymphoma,Osteosarcoma,Ovarian Cancer,Prostate Cancer,Sarcoma,T-ALL

    Age

    18+

    Phase

    Phase 1/Phase 2

    Participants needed

    200

    Est. Completion Date

    Dec 2022

    Treatment type

    Interventional


    Sponsor

    Cellestia Biotech AG

    ClinicalTrials.gov identifier

    NCT03422679

    Study number

    CB103-C-101

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