A Study of IMM 101 in combination with various standard cancer treatments in patients with advanced cancer or cancer which cannot be removed by surgery.
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]Metastatic Cancer or Unresectable CancerMedDRA version: 19.1Level: PTClassification code 10028980Term: NeoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2016-001459-28-GB
- Lead Sponsor
- Immodulon Therapeutics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2
Patients are eligible to be included in the study if they:
1. Have metastatic or unresectable cancer and are considered by their physician to be indicated for a new line of SOC chemotherapy, as listed
2. Are ineligible for a disease specific clinical study with IMM 101
3. Have an estimated life expectancy greater than 3 months (from Day 0)
4. Give signed informed consent for participation in the study
5. Have an Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) Performance Status of =2 at Day 0.
6. Have adequate bone marrow, hepatic and renal function including the following:
a.Haemoglobin (Hb) =9.0g/dL, absolute neutrophil count =1.5 x 109/L, platelets =75 x 109/L
b.Total bilirubin =1.5 x upper limit of normal (ULN), excluding cases where elevated bilirubin can be attributed to Gilbert's Syndrome
c. Aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]), alanine transaminase (ALT; serum glutamate pyruvate transaminase [SGPT]) =5 x ULN
d. Creatinine =1.5 x ULN
e. Serum albumin >28g/L
f. International normalised ratio (INR) <1.5 or a prothrombin time/partial thromboplastin time (Pt/PTT) within normal limits
g. C reactive protein (CRP) <20 mg/L for patients with solid tumours
7. Are aged =18 years.
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
Patients will be ineligible if one or more of the following statements are applicable:
1. Patient has previously received treatment with IMM 101
2. Patient is currently part way through a course of chemotherapy
3. Patient is receiving concomitant treatment with another investigational product
4. Patient has received an investigational drug within the 4 weeks prior to IMM-101 administration
5. Patient has significant cardiovascular disease as defined by:
a. History of congestive heart failure requiring therapy
b. History of unstable angina pectoris or myocardial infarction up to 6 months prior to study entry
c. Presence of valvular heart disease
d. Presence of a ventricular or supra ventricular arrhythmia requiring ongoing treatment
e. Left ventricular ejection fraction (LVEF) <50% (or less than the institutional norm)
6. Patient has any previous or concurrent malignancy. Patients will not be excluded if they have adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non melanoma skin cancer, or if previous malignancy was more than 5 years prior to Screening and there are no signs of recurrence
7. Patient has co existing active infection or medical condition which, in the Investigator’s judgement, will substantially increase the risk associated with the patient’s participation in the study
8. Patient has uncontrolled hypercalcaemia (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE] v4.0[1] >Grade 1)
9. Patient is pregnant or a breast feeding woman. Female patients with reproductive potential must have a negative serum pregnancy test (ß human chorionic gonadotropin [ß hCG]) within 72 hours prior to start of the study. Both women and men must agree to use a medically acceptable, effective method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable, effective methods of contraception include intrauterine device (IUD), intrauterine hormone releasing system (IUS), oral contraceptive (progestogen only oral contraception that does not inhibit ovulation is not an acceptable method), bilateral tubal occlusion, vasectomised partner, and subdermal implant
10. Patient has used depot corticosteroids in the 6 weeks before initiation of Screening (signing of the informed consent form [ICF])
11. Patient has had chronic use of systemic corticosteroids (>10 mg per day of prednisolone or equivalent for a period of 2 weeks or more) and/or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporin) within the 2 week period before the first administration of IMM-101
12. Patient has received a blood transfusion within 4 weeks prior to Screening
13. In the opinion of the Investigator, the patient is unable or unwilling to comply with the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to provide safety data for IMM 101 in combination with a number of selected chemotherapy regimens;Secondary Objective: The secondary objectives of the study are to provide:<br>Safety and tolerability data for extended admininstration (beyond 28 weeks) of IMM 101 in combination with a number of selected chemotherapy regimens.<br>Preliminary data regarding the activity of IMM 101 (in terms of response to treatment) in combination with recognised SOC in a number of different tumour types.<br>Disease outcome data. <br>Monitoring of selected markers of tumour burden and immunological status in patients taking IMM-101<br>;Primary end point(s): Safety and Tolerability as measured by<br>• AEs<br>• Laboratory abnormalities<br>• Local injection site reactions<br>;Timepoint(s) of evaluation of this end point: Up to and including 30 days after the end of the patients participation in the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Activity as defined by<br>• Response to treatment, (defined as immune related Stable Disease [irSD], immune related Partial Response [irPR] and immune related Complete Response [irCR]) as assessed by the Investigator<br>• Overall survival (OS) <br>• Immunological markers (Serum: micro ribonucleic acid [miRNA] panel, circulating metabolites. FACS: immune cell quantifications: TruCulture: cytokines, chemokines, immune mediators, functional immune cell assays, tumour markers) <br>•Additional evaluations may be considered as driven by the evolving understanding of the mechanism of action, technical feasibility, and any other clinical or immunological information that may become available.<br>;Timepoint(s) of evaluation of this end point: Response to treatment will be measured at Week 28.<br>Overall survival will be measured at the end of study<br>Other secondary endpoints will be measured periodically throughout the study