NCT03422679

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

A Phase I/IIA, Multi-Centre, Open-Label, Dose-Escalation Study With Expansion Arms to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CB-103 Administered Orally in Adult Patients With Locally Advanced or Metastatic Solid Tumours and Haematological Malignancies Characterised by Alterations of the NOTCH Signalling Pathway

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Cellestia Biotech AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Breast Cancer
• Colorectal Cancer
• Adenoid Cystic Carcinoma
• Non-hodgkin Lymphoma
• Glomus Tumor, Malignant
• Hepatocellular Carcinoma
• Osteosarcoma
• T-ALL

Interventions

Type	Name	Description
DRUG	CB-103	Hard gelatine capsules taken orally during treatment period. Treatment cycle is 28 days.

Timeline

• Start date: 2017-12-05
• Primary completion: 2022-11-11
• Completion: 2022-11-11
• First posted: 2018-02-06
• Last updated: 2024-01-16
• Results posted: 2024-01-16

Locations

17 sites across 6 countries: United States, France, Germany, South Korea, Spain, Switzerland

Regulatory

• FDA-regulated drug study