Breast Cancer Clinical Trial
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 Locally Advanced or Metastatic Solid Tumours and Haematological Malignancies Characterised by Alterations of the NOTCH Signalling Pathway
Verified date | January 2024 |
Source | Cellestia Biotech AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a phase I/II, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of CB-103.
Status | Terminated |
Enrollment | 79 |
Est. completion date | November 11, 2022 |
Est. primary completion date | November 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. 3. Prior Therapy - In patients with solid tumours cytotoxic chemotherapy within 3 weeks - In T-ALL/T-LBL patients, prior anticancer therapy less than 2 weeks prior to starting therapy or 5 half-lives (whichever is longer) with exceptions. - Radiation therapy within 2 weeks of scheduled CB-103 dosing day 1 - Immunotherapy, biological therapies, targeted small molecules, hormonal therapies within 3 weeks of scheduled CB-103 dosing day 1 - Unresolved toxicity CTCAE grade > 1 from previous anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity, lymphopenia), or incomplete recovery from previous surgery. |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Lyon-Sud | Lyon | |
France | Hôpital Saint-Louis | Paris | |
Germany | Charite- Universitaetsmedizin Berlin- Campus Benjamin Franklin | Berlin | |
Germany | Universitätsklinikum Frankfurt | Frankfurt | |
Germany | Nationales Centrum für Tumorerkrankungen Heidelberg | Heidelberg | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital - Yonsei Cancer Center | Seoul | |
Spain | Catalan Institute of Oncology | Barcelona | |
Spain | Hospital Quirón Barcelona | Barcelona | |
Spain | Vall d'Hebron Institute of Oncology (VHIO) | Barcelona | |
Spain | Hospital Ramón y Cajal | Madrid | |
Switzerland | Oncology Institute of Southern Switzerland | Bellinzona | |
Switzerland | Kantonsspital St.Gallen | Saint Gallen | |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | MD Anderson | Houston | Texas |
United States | Sarcoma Oncology Research Center | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Cellestia Biotech AG |
United States, France, Germany, Korea, Republic of, Spain, Switzerland,
Hanna GJ, Stathis A, Lopez-Miranda E, Racca F, Quon D, Leyvraz S, Hess D, Keam B, Rodon J, Ahn MJ, Kim HR, Schneeweiss A, Ribera JM, DeAngelo D, Perez Garcia JM, Cortes J, Schonborn-Kellenberger O, Weber D, Pisa P, Bauer M, Beni L, Bobadilla M, Lehal R, Vigolo M, Vogl FD, Garralda E. A Phase I Study of the Pan-Notch Inhibitor CB-103 for Patients with Advanced Adenoid Cystic Carcinoma and Other Tumors. Cancer Res Commun. 2023 Sep 14;3(9):1853-1861. doi: 10.1158/2767-9764.CRC-23-0333. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose Limiting Toxicity (DLT) | 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). |
28 days | |
Secondary | Overall Response Rate | Number of patients with an overall response rate (CR+PR assessed by RECSIT v1.1 or CR or CRi by NCCN guidelines) up to 24 months | 24 months |
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