Last updated on February 2019

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


Brief description of 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.

Detailed Study Description

This Phase I/IIA, open label, multicenter, dose escalation study of CB-103 in patients with Advanced or Metastatic Solid Tumours and Haematological Malignancies. After providing signed informed consent, patients will be screened for entry into the study. The study will be conducted in 2 stages. In a dose escalation stage, approximately 25 patients will be enrolled. Escalation cohorts of 3 to 6 patients will receive repeat doses of CB-103 to determine the MTD and RP2D. A Bayesian logistic regression model with overdose control is used.

CB-103 will be administered orally on a once-daily schedule, based on a 28-day treatment cycle. Aim of the expansion Phase IIA, Part B of the study will be to collect preliminary evidence of anti-tumour activity and to confirm the safety of the CB-103 MTD/RP2D in different expansion arms consisting of up to 140 patients with pre-selected cancer indications with tumour cells characterised by NOTCH over-activation.

Clinical Study Identifier: NCT03422679

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Recruitment Status: Open


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