Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT03009058
Eligibility Criteria:
Inclusion Criteria:
* Metastatic or unresectable cancer and considered by their physician to be indicated for a new line of SOC as listed in the protocol
* Are ineligible for a disease specific clinical study with IMM-101
* Have an estimated life expectancy greater than 3 months (from Day 0)
* Give signed informed consent for participation in the study
* Have an Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) Performance Status of ≤2 at Day 0.
* Have adequate bone marrow, hepatic and renal function
Exclusion Criteria:
* Patient has previously received treatment with IMM-101
* Patient is currently part way through a course of chemotherapy or immunotherapy
* Patient is receiving concomitant treatment with another investigational product
* Patient has received an investigational drug within the 4 weeks prior to IMM 101 administration
* Patient has significant cardiovascular disease
* Patient has any previous or concurrent malignancy (excluding 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)
* Patient has co existing active infection or medical condition which will substantially increase the risk associated with the patient's participation in the study
* Patient has uncontrolled hypercalcaemia
* Patient has previously experienced an allergic reaction to any mycobacterial product.
* The patient has a history of non-infectious pneumonitis that required steroids or current pneumonitis
* Patient has received live vaccine within 30 days of planned start of study medication
* Patient is pregnant or a breast feeding woman.
* Patient is unwilling to use a medically acceptable, effective method of contraception throughout the treatment period and for at least 6 months after discontinuation of treatment.
* Patient has used depot corticosteroids in the 6 weeks before initiation of Screening
* Patient has had chronic use of systemic corticosteroids within the 2 week period before the first administration of IMM-101
* Patient has received a blood transfusion within 4 weeks prior to Screening
* In the opinion of the Investigator, the patient is unable or unwilling to comply with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03009058
Study Brief:
Protocol Section:
NCT03009058