Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03422679|
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Colorectal Cancer Cholangiocellular Carcinoma Sarcoma Desmoid Tumour Adenoid Cystic Carcinoma Non-hodgkin Lymphoma Glomus Tumor, Malignant||Drug: CB-103||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Advanced or Metastatic Solid Tumours and Haematological Malignancies Characterised by Alterations of the NOTCH Signalling Pathway|
|Actual Study Start Date :||December 5, 2017|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
CB-103 capsules will be administered orally as a continuous once daily (QD) dosing during the treatment period of Part A (escalation) and Part B (expansion).
Capsules, taken once daily during treatment period A and B. Treatment cycle is 28 days.Starting dose is 15 mg.
- Part A: Dose limiting toxicity (DLT) [ Time Frame: 28 days ]Number of patients with dose limiting toxicity
- Part B: antitumour efficacy [ Time Frame: up to 12 months ]Best overall response rates of each tumor type using appropriate response Evaluation Criteria
- Part A and B: incidence of all adverse events and serious adverse events (safety and tolerability) [ Time Frame: up to 12 months ]Number of participants with adverse events as a measure of safety and tolerability
- Part A and B: pharmacokinetic - Cmax [ Time Frame: PK profiling in cycle 1 and 2 (cycle duration: 28 days) ]Maximum plasma concentration
- Part A and B: pharmacokinetic - tmax [ Time Frame: PK profiling in cycle 1 and 2 (cycle duration: 28 days) ]Time to Cmax
- Part A and B: pharmacokinetic - AUC [ Time Frame: PK profiling in cycle 1 and 2 (cycle duration: 28 days) ]Area under the curve during 8 and 24 hours
- Part A and B: pharmacokinetic - t1/2 [ Time Frame: PK profiling in cycle 1 and 2 (cycle duration: 28 days) ]elimination half-life
- Part A: preliminary antitumour efficacy [ Time Frame: up to 6 months ]Overall response rates of each tumor type using appropriate response evaluation criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422679
|Contact: Michael Bauer, PhD||+41 61 firstname.lastname@example.org|
|Academic Medical Center||Not yet recruiting|
|Amsterdam, Netherlands, 1105 AZ|
|Maastricht, Netherlands, 6202 AZ|
|UMC Utrecht Cancer Center||Recruiting|
|Utrecht, Netherlands, 3508 GA|
|Instituto Oncológico Baselga. IOB||Recruiting|
|Barcelona, Spain, 08023|
|Vall d'Hebron Institute of Oncology (VHIO)||Recruiting|
|Barcelona, Spain, 08035|
|Hospital Ramón y Cajal||Recruiting|
|Madrid, Spain, 28034|
|Oncology Institute of Southern Switzerland||Recruiting|
|Bellinzona, Switzerland, 6500|