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Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

NCT03422679•Cellestia Biotech AG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Disease
•* Patients with histologically or cytologically confirmed solid tumours (breast cancer (triple negative breast cancer \[TNBC\], ER+/-, HER2+/-), gastrointestinal (GI) cancers (resistant to oxaliplatin or irinotecan-based therapy colorectal cancer \[CRC\]), osteosarcoma, adenoid cystic carcinoma (ACC), and malignant glomus tumour) that are surgically unresectable, locally advanced, or metastatic and whose disease has progressed on at least one line of systemic therapy (with the exception of ACC patients who are allowed to be systemic treatment-naïve) and for whom no established therapeutic alternatives exist. Any other solid cancer (including lymphoma) with a confirmed NOTCH1-4 activating mutation or genetic lesion.
•* Relapsed or refractory (r/r) T-cell acute lymphoblastic leukaemia (T-ALL) or lymphoma (T-LBL) with a confirmed NOTCH pathway activation. Refractory patients are defined as T-ALL/T-LBL patients with ≥ 5% bone marrow blasts, and/or concomitant extramedullary involvement, who have not achieved a CR after standard induction/consolidation therapy attempt.
•2. Demography: men and women ≥ 18 years old
•3. Adequate organ function and laboratory results
•4. Adequate contraceptive measures
•5. Signed informed consent

Exclusion Criteria

•1. Medical History
•1. Patients with symptomatic CNS metastases (neurologically unstable or requiring increasing doses of steroids to control their CNS disease)
•2. Hypersensitivity to any of the excipients of CB-103
•3. Patients with unresolved nausea, vomiting, or diarrhoea of CTCAE grade \> 1
•4. Impairment of GI function or presence of GI disease that may significantly alter the absorption of CB-103
•5. History of second or other primary cancer with the exception of:
•* Curatively treated non-melanomatous skin cancer
•* Curatively treated cervical cancer or breast carcinoma in situ
•* Other primary solid tumour treated with curative intent and no known active disease present and no treatment administered during the last 2 years.
•2. Exclusionary concurrent medical conditions Impaired cardiac function or clinically significant cardiac diseases.
+6 more criteria

Locations (17)

Sarcoma Oncology Research Center

Santa Monica, California, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

MD Anderson

Houston, Texas, United States

Centre Hospitalier Lyon-Sud

Lyon, France

Hôpital Saint-Louis

Paris, France

Charite- Universitaetsmedizin Berlin- Campus Benjamin Franklin

Berlin, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Nationales Centrum für Tumorerkrankungen Heidelberg

Heidelberg, Germany

Seoul National University Hospital

Seoul, South Korea

Severance Hospital - Yonsei Cancer Center

Seoul, South Korea

Key Dates

Start Date

December 5, 2017

Primary Completion Date

November 11, 2022

Completion Date

November 11, 2022

Last Updated

January 16, 2024

Enrollment

ACTUAL participants

Conditions

Breast CancerColorectal CancerAdenoid Cystic CarcinomaNon-hodgkin LymphomaGlomus Tumor, MalignantHepatocellular CarcinomaOsteosarcomaT-ALL

Interventions

CB-103

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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