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

  • STATUS
    Recruiting
  • days left to enroll
    27
  • participants needed
    200
  • sponsor
    Cellestia Biotech AG
Updated on 25 March 2022
platelet count
cancer
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lymphoma
hodgkin's disease
amylase
metastatic disease
systemic therapy
carcinoma
breast cancer
warfarin
anticoagulants
small molecule
lipase
growth factor
potassium
bone marrow procedure
serum bilirubin
serum bilirubin level
cytotoxic chemotherapy
metastasis
oxaliplatin
hormone therapy
HER2
irinotecan
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carcinoma in situ
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phenytoin
aptt
follicular lymphoma
cancer chemotherapy
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
solid tumour
alopecia
triple negative breast cancer
erbb2
breast carcinoma
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cb-103
t-cell lymphoma
peripheral t-cell lymphoma
anaplastic large cell lymphoma
marginal zone lymphoma
ototoxicity
large b-cell lymphoma
mammogram
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fibrosarcoma
liposarcoma

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.

Details
Condition Breast Cancer, Colorectal Cancer, Adenoid Cystic Carcinoma, Non-hodgkin Lymphoma, Glomus Tumor, Malignant, Hepatocellular Carcinoma, Osteosarcoma, T-ALL
Treatment CB-103
Clinical Study IdentifierNCT03422679
SponsorCellestia Biotech AG
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Demography: men and women ≥ 18 years old
Adequate organ function and laboratory results
Adequate contraceptive measures
Signed informed consent
Exclusionary concurrent medical conditions Impaired cardiac function or clinically
significant cardiac diseases
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
EXCLUSION CRITERIA
Medical History
Patients with symptomatic CNS metastases (neurologically unstable or requiring increasing doses of steroids to control their CNS disease)
Hypersensitivity to any of the excipients of CB-103
Patients with unresolved nausea, vomiting, or diarrhoea of CTCAE grade > 1
Impairment of GI function or presence of GI disease that may significantly alter the absorption of CB-103
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
Prior Therapy
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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