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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03422679
Other study ID # CB103-C-101
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date December 5, 2017
Est. completion date November 11, 2022

Study information

Verified date January 2024
Source Cellestia Biotech AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
CB-103
Hard gelatine capsules taken orally during treatment period. Treatment cycle is 28 days.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Cellestia Biotech AG

Countries where clinical trial is conducted

United States,  France,  Germany,  Korea, Republic of,  Spain,  Switzerland, 

References & Publications (1)

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

Outcome

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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