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This is a phase I/II, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of CB-103.
Full description
This Phase I/IIA, open label, multicenter, dose escalation study of CB-103 in patients with Locally 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: dose escalation in Part A of the study (Phase I) followed by dose expansion in Part B (Phase IIA).
Escalation cohorts will receive repeat doses of CB-103 to determine the MTD and RP2D.
CB-103 will be administered orally in treatment cycles of 28-days each. Aim of the expansion Phase IIA, Part B of the study will be to collect preliminary evidence of anti-tumour activity.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
INCLUSION CRITERIA:
Disease
Demography: men and women ≥ 18 years old
Adequate organ function and laboratory results
Adequate contraceptive measures
Signed informed consent
EXCLUSION CRITERIA
Medical History
Patients with symptomatic CNS metastases (neurologically unstable or requiring increasing doses of steroids to control their CNS disease)
Hypersensitivity to any of the excipients of CB-103
Patients with unresolved nausea, vomiting, or diarrhoea of CTCAE grade > 1
Impairment of GI function or presence of GI disease that may significantly alter the absorption of CB-103
History of second or other primary cancer with the exception of:
Exclusionary concurrent medical conditions Impaired cardiac function or clinically significant cardiac diseases.
Prior Therapy
Primary purpose
Allocation
Interventional model
Masking
79 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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