Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer

• Status: Terminated
• Trial end date: 2017-08-30
• Target enrollment: 0
• Participant gender: All

Summary

During this open label study patients will receive IMM-101 in conjunction with a recognised standard of care for metastatic or unresectable cancer for the patient's specific tumour type.

The primary objective of the study is to provide safety data for IMM-101 in combination with a number of selected standard of care regimens.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immodulon Therapeutics Ltd
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Cetuximab; Cyclophosphamide; Fluorouracil; Folic Acid; Gemcitabine; Ipilimumab; Irinotecan; Leucovorin; Levoleucovorin; Nivolumab; Oxaliplatin; Paclitaxel; Pembrolizumab

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.