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

Cellestia Biotech AG16 sites in 6 countries79 target enrollmentDecember 5, 2017

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

InterventionsCB-103

DrugsCB-103

Overview

Phase: Phase 1
Intervention: CB-103
Conditions: Breast Cancer
Sponsor: Cellestia Biotech AG
Enrollment: 79
Locations: 16
Primary Endpoint: Dose Limiting Toxicity (DLT)
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 5, 2017

End Date

November 11, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cellestia Biotech AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

CB-103

CB-103 capsules will be administered orally in treatment cycles of 28-days each.

Intervention: CB-103

Outcomes

Primary Outcomes

Dose Limiting Toxicity (DLT)

Time Frame: 28 days

Number of patients with dose limiting toxicity during the first cycle. DLT is defined as a severe adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications, that occurs ≤ 28 days following the first dose of CB-103 (Cycle 1).