A study to investigate the safety and efficacy of CXD101 in combination with nivolumab in previously treated patients with colorectal cancer that has spread to other parts of the body

Phase 1

• Conditions: Metastatic, Previously-Treated, Microsatellite-Stable Colorectal Carcinoma; MedDRA version: 21.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10010036 Term: Colorectal carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004509-42-GB
• Lead Sponsor: Celleron Therapeutics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-02
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 55

Inclusion Criteria

-Written informed consent
-Biopsy-confirmed MSS, Mismatch Repair proficient (MMR-P) CRC
-Previous first and second line treatment/adjuvant therapy, including use of oxaliplatin and irinotecan unless documented intolerance of these
-Measurable disease: longest diameter=10mm (short axis =15mm for nodal lesions)
-Age >= 18 years
-Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
-Predicted life expectancy > 3 months
-Adequate organ and bone marrow function: Hb> 10.0g/dL (may be transfused to this level), neutrophils> 1.5x10^9/L and platelets> 100x10^9/L
-Female patients with reproductive potential must have a negative urine and serum pregnancy test prior to starting treatment.
-Both women of reproductive potential and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 5 months after discontinuation of treatment
-All males with partners of childbearing potential or whose partners are pregnant must use barrier contraception for the duration of dosing and for 5 months post-dosing.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

Exclusion Criteria

-Pregnant or breast feeding
-Pre-existing auto-immune conditions
-Medical conditions requiring systemic immunosuppression
-Previous treatment with an HDAC inhibitor or PD1/PDL1 inhibitor
-Other chemotherapy, radiotherapy, or investigational therapy within 4 weeks prior to the Screening /Baseline Assessment
-Unresolved clinically significant toxicity from a previous treatment
-History of recent active chronic inflammatory bowel disease and/or bowel obstruction
-Renal function: Serum creatinine >= 1.5 x ULN, or creatinine clearance < 60mL/min (Cockcroft-Gault formula)
-Liver function: AST > 3.0; OR total bilirubin >1.5 x ULN. For subjects with involvement of metastatic liver disease: AST > 5.0 x ULN; OR total bilirubin > 3.0 x ULN
-Clinically significant myocardial infarction, severe/unstable angina pectoris, congestive heart failure NYHA Class III or IV, or pulmonary disease within 6 months
-Symptomatic brain metastasis, uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
-Clinically significant active infection requiring antibiotic or antiretroviral therapy
-History of malignancy other than MSS CRC, unless there is the expectation that the malignancy has been cured, and tumour specific treatment for the malignancy has not been administered within the previous 5 years
-History of pneumonitis, immune hepatitis or myocarditis, or current uncontrolled thyroid disease
-Current positive serology for Hepatitis B or C virus
-History of any allergy to excipients of the Investigational Medicinal Products (sodium citrate dihydrate, sodium chloride, mannitol, pentetic acid, Polysorbate 80, sodium hydroxide, hydrochloric acid, hydroxypropyl methylcellulose)
-Receipt of any live vaccine 30 days or fewer prior to administration of first dose IMP
-Inability to comply with the study protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified