Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adenoid Cystic Carcinoma
- Breast Cancer
- Cholangiocellular Carcinoma
- Colorectal Cancer
- Desmoid Tumour
- Glomus Tumor, Malignant
- Non Hodgkin Lymphoma
- Sarcoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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: dose...
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: dose escalation in Part A of the study 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 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.
Tracking Information
- NCT #
- NCT03422679
- Collaborators
- Not Provided
- Investigators
- Not Provided