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

  • STATUS
    Recruiting
  • days left to enroll
    88
  • participants needed
    165
  • sponsor
    Cellestia Biotech AG
Updated on 26 January 2021
platelet count
cancer
calcium
lymphoma
hodgkin's disease
amylase
metastatic disease
systemic therapy
carcinoma
breast cancer
warfarin
anticoagulants
small molecule
lipase
growth factor
potassium
serum bilirubin
serum bilirubin level
cytotoxic chemotherapy
metastasis
hormone therapy
HER2
blood transfusion
carcinoma in situ
chemotherapy regimen
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
sarcoma
cb-103
t-cell lymphoma
peripheral t-cell lymphoma
anaplastic large cell lymphoma
marginal zone lymphoma
large b-cell lymphoma
mammogram
hodgkin lymphomas
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 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.

Details
Condition Malignant neoplasm of prostate, Non-Small Cell Lung Cancer, Cervical Cancer, Adenocarcinoma, Hodgkin's Disease, Adenoid Cystic Carcinoma, Colorectal Cancer, Connective and Soft Tissue Neoplasm, Cholangiocarcinoma, Multiple Myeloma, Rectal disorder, Lymphoma, Breast Cancer, Aggressive fibromatosis, Ovarian Cancer, Glioblastoma Multiforme, melanoma, skin cancer, Lymphoma, Sarcoma, Gastric Cancer, Metastatic Melanoma, Non-Hodgkin's Lymphoma, All Solid Tumors, Colon Cancer Screening, Prostate Cancer, Early, Recurrent, Rectal Disorders, Solid Tumors, Colon cancer; rectal cancer, Breast Cancer Diagnosis, Recurrent Ovarian Cancer, Advanced or Metastatic Solid Tumours, Sarcoma (Pediatric), Desmoid Tumors, Prostate Cancer, Malignant Melanoma, Malignant Adenoma, Stomach Cancer, Soft Tissue Sarcoma, Glomus Tumor, Malignant, Glomus Tumor, Malignant, Glomus Tumor, Malignant, Glomus Tumor, Malignant, breast carcinoma, colorectal neoplasm, non-hodgkin's lymphoma (nhl), sarcomas, soft tissue sarcomas, cancer, breast, colorectal cancers, cancer, colorectal, colorectal tumor, tumors, colorectal, desmoid tumor, Glomus Tumor, Malignant
Treatment CB-103
Clinical Study IdentifierNCT03422679
SponsorCellestia Biotech AG
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Disease
Patients with histologically or cytologically confirmed solid tumours that are surgically unresectable, locally advanced, or metastatic and whose disease has progressed on at least one line of systemic therapy and for whom no standard curative therapy exists
The following solid tumour indications are allowed to be enrolled into Part A of this study (dose escalation) based on known involvement of the NOTCH pathway activation in these indications: Breast cancer (triple negative breast cancer [TNBC], ER+/-, HER2+/-), gastrointestinal (GI) cancers (colorectal cancer [CRC], cholangiocellular carcinoma [CCC]), sarcomas (osteosarcoma, liposarcoma, rhabdomyosarcoma, fibrosarcoma), desmoid tumours, adenoid cystic carcinoma, and malignant glomus tumour
Patients with histologically or cytologically confirmed, advanced haematological malignancies) whose disease has relapsed or progressed upon standard therapy and for whom at that point no standard therapy exists: Non-Hodgkin lymphomas (NHL): Follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma, marginal zone B cell lymphoma (MZCL), splenic marginal zone lymphoma (SMZL), mantle cell lymphoma (MCL), peripheral T-cell lymphoma (PTCL), anaplastic large cell lymphoma (ALCL)
Demography Men and women 18 years old on the day of signing informed consent
Organ function and laboratory results
Patients must have the following laboratory values
a.ANC 1.5x10^9/L (solid tumour indications) or 1.0x10^9/L (haematological
malignancies) b.Haemoglobin (Hgb) 10 g/dL ( 100 g/L) c.Platelet count 75 x
L (no platelet transfusion or growth factor support in the preceding 7d)
d.Total serum bilirubin 1.5xULN e.ALP 2.5xULN (if abnormalities are due to the
underlying malignancy and known bone metastases, then ALP must be 5xULN)
f.AST/SGOT and ALT/SGPT 2.5xULN (if abnormalities are due to the underlying
malignancy and known hepatic metastases, AST and ALT must be 5xULN) g.Serum
creatinine 1.5xULN (if serum creatinine > 1.5xULN, then serum creatinine
clearance (CrCl) 50 mL/min h to k: Potassium, Total calcium (corrected for
serum albumin), Magnesium and Phosphorus levels: within normal limits or
correctable with supplements l.Serum albumin concentration 30 g/L m.Serum
amylase and serum lipase ULN n.PTT 1.5 x ULN and INR 1.3 (unless receiving
therapeutic anticoagulants)
\. Contraceptive measures
Women of childbearing potential and men must agree to use at least two highly effective forms of contraception throughout the entire clinical trial period and for 90d post-treatment completion
Men whose partners could be of childbearing potential must routinely use a condom throughout the clinical trial period and for 90d posttreatment completion. The partner should also use a reliable form of contraception. 5. Signed informed consent
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
Exclusionary concurrent medical conditions Impaired cardiac function or clinically significant cardiac diseases
Prior Therapy
Cytotoxic chemotherapy within 3 weeks
Any investigational treatment (including NOTCH signaling inhibitors and prior treatment with CB-103) within 4 weeks of scheduled CB-103 dosing day 1
Concurrent enrolment in another therapeutic clinical trial involving ongoing therapy with any investigational or marketed product or placebo
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
Current medications
Drugs which prolong QT interval
Acid reducing agents
Patients receiving warfarin and phenytoin that cannot be discontinued at least one week prior to start of treatment with CB-103 and for the duration of the study
Anticoagulants
Demography
Patients who are pregnant or breast feeding
Others - Patients who are unable or unwilling to comply with all study requirements for clinical visits, examinations, tests, and procedures
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